Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: randomised, controlled feasibility trial in primary care in rural Ethiopia

doi:10.21203/rs.3.rs-4564665/v1

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Research Article

Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: randomised, controlled feasibility trial in primary care in rural Ethiopia

https://doi.org/10.21203/rs.3.rs-4564665/v1

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Background: We adapted problem-solving therapy (PST) to support improved treatment of antenatal depression in maternal care platforms in Ethiopia. In this study, we aimed to: (1) assess acceptability, fidelity, feasibility and potential efficacy of PST for antenatal depression in rural Ethiopia, and (2) examine the feasibility of procedures of a randomised, controlled study design, to inform a future, fully-powered randomised controlled trial (RCT).

Methods: We recruited fifty consecutive women attending primary healthcare-based antenatal care in two PHC facilities in (Bui and Kella), based on pre-established eligibility criteria. A randomised, controlled feasibility trial design with two parallel groups was employed. The intervention arm received four sessions of a contextually adapted version of PST. Enhanced Usual Care (EUC) involved antenatal care counselling, and information about sources of support. Assessments were conducted at baseline and nine weeks after randomisation. We used a locally validated version of the Patient Health Questionnaire-9 (PHQ-9) to assess antenatal depressive symptoms. A range of other outcomes, including functioning (WHODAS-12), anxiety (GAD-7) and process outcomes were assessed. Descriptive statistics were employed to summarise process indicators, participant characteristics and trial outcome measures.

Results: Out of a total of 335 antenatal women approached for initial eligibility assessment over a period of 20 days, 154 (46%) met initial eligibility to proceed to screening. After screening and the consent process, we randomised the remaining 50 eligible women into PST and EUC arms; 64% completed the intervention. Almost all outcome measures favoured the intervention arm compared to the EUC arm. Trial procedures such as participant recruitment and concealment were feasible. Supervision reports indicated that healthcare workers (HCWs) adhered to most of the content of the intervention except in situations when women reported not having problems or worries. Supervision reports indicated that HCWs appreciated skills gained in PST. However, they commented on the need to shorten trainer demonstrations of some sessions while focusing on trainees’ practical exercises and using video recorded role play.

Conclusion: Participant recruitment, screening, randomization, masking, as well as the intervention delivery process, were feasible. Future design of efficacy trials need to emphasise practical exercises to support training.

Trial registration: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578. The protocol has also been published: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8

antenatal depression

Problem Solving therapy

feasibility trial

Ethiopia

1) Some of the challenges that might have affected the feasibility of the intervention and its preliminary effectiveness include: 1) women’s attribution of problems to either poverty or problems with their husbands, 2) women becoming distracted by their children, 3) women’s confidence to discuss in Amharic and/or audio recording, 4) HCWs’ focus on recording women’s worries instead of listening and 5) the cultural practice of postnatal confinement limiting some participants from completing all four sessions or attending an outcome assessment.

2) The feasibility of participant recruitment and randomisation was evidenced with our ability to approach 17 women per day, of whom nearly half met eligibility criteria. Randomization to PST and EUC arms was feasible and acceptable, as were masking outcome assessors and investigators to allocation status as well as baseline and outcome assessments nine weeks later. Although this feasibility study was not powered to evaluate effectiveness, changes in mean clinical outcome scores such as GAD-7 and PCL-5 and hypothesised mediators (perceived social support, self-efficacy, mastery) favoured the PST arm over EUC. Each PST session lasted an average of 41 minutes which was longer than intended. Techniques such as ‘worry time’ and relaxation exercises were appreciated, supporting the appropriateness of the PST model. Most (64% of women in the PST arm) attended all the intervention sessions. Participants’ dropping –out of the study for reasons other than moving away from the study site were rare and acceptability of the intervention was increased through integration into existing ANC in PHC facilities. However, only an average of 58% of HCWs attained the expected ENACT score, indicating lower than expected competency.

3) The study demonstrated the feasibility of recruitment, randomisation and concealment of participants and the intervention delivery process. Future efficacy trials should re-consider gestational age for recruitment, women postnatal confinement and session recording. The session content may need to be reduced to enable this intervention to be integrated into ANC.

Depression in the antenatal period substantially contributes to maternal morbidity worldwide (1). In low- and middle-income countries (LMICs), maternal depression is estimated to adversely affect about 16% of pregnant women (2, 3) and has been associated with functional impairment (4–6) such as reduced self-care (7–9), greater household food insecurity (10), and somatic complaints (5, 11, 12). After childbirth, depression has also been found to be associated with delayed initiation of breast-feeding (13), poor mother-infant attachment, maternal and child undernutrition (13, 14), and poor child health (13). In our previous work in rural Ethiopia, depression during pregnancy was associated with increased perinatal physical health complications (15), increased use of emergency healthcare (16), and unplanned (emergency) institutional delivery (17).

Although improved detection and treatment of antenatal depression integrated into maternal care platforms, particularly within primary healthcare (PHC) settings, has been recommended (5, 11, 12), this is not prioritised in many LMICs (18). Evidence-based guidance recommends treating depressed women with antidepressants and/or psychotherapies in PHC-based maternal care services. However, antidepressants are only appropriate for moderate-severe depression (19, 20) and medication has low acceptability in pregnant women (21, 22). Furthermore, lower levels of depressive symptoms that do not necessarily meet criteria for a diagnosis of major depressive disorder and that can be treated effectively with psychological treatments (23–26) have been shown to be associated with functional impairment and adverse effects on the woman and the fetus(27, 28).

In Ethiopia, mental healthcare remains highly centralised. Mental health specialists, located in urban hospitals (over 80% of the population lives in rural areas) focus on treating people with severe mental illness, leaving a large treatment gap (96%) for perinatal depression (29). The Federal Ministry of Health is seeking to expand access to mental health care in Ethiopia through integration in PHC and maternal care platforms (30), but is hampered by the lack of therapeutic options for depressed pregnant women. Culturally and contextually relevant and scalable psychological interventions are needed to address this gap.

The World Health Organization mental health gap action programme (mhGAP) intervention guide for PHC workers recommends several brief, manualised psychological therapies for people with depression, highlighting the need to adapt interventions to the cultural context (31). In our formative qualitative work, pregnant and postpartum women and community healthcare workers perceived depressive symptoms as responses to situational challenges (32) which may thus be amenable to problem-orientated psychological interventions(33).

We selected the South African version of the PST (34), adapted and manualised Problem Solving Therapy (PST) for pregnant women with antenatal depressive symptoms in a rural Ethiopian setting (35) due to its suitability for empowering women in low-income, rural areas with problem solving skills (36). PST can be delivered by non-specialist, community and healthcare workers (25) in the context of routine maternal and child healthcare (23, 24). In meta-analyses, PST has been found to be effective for treatment of depression in comparison to no treatment (37, 38). Pragmatic trials of the South African version of PST demonstrated significant reductions in severity of depressive symptoms at 12 months (39). Furthermore, PST is simple, acceptable and effective in a low literacy population (37, 40–42). Our adaptation process was guided by the Medical Research Council (MRC) framework for development and evaluation of complex interventions (43) and the ‘ADAPT-ITT’ approach (44) to adaptation. This adaptation process comprised a series of theory of change workshops with stakeholders, adaptation workshops, in-depth interviews with women with a history of perinatal depression and healthcare providers. Once adapted, PST was demonstrated to stakeholders through role play ‘theatre testing’, after which their feedback was incorporated into further adaptations(35).

MRC guidance recommends testing any adapted intervention’s feasibility, acceptability, provider fidelity and preliminary effectiveness. Interventions should be acceptable to stakeholders with respect to culture, programme theory, timing, and human and material resource implications. Provider fidelity refers to the adherence of therapists to the planned material. In this study, we aimed to: (1) assess acceptability, provider fidelity and feasibility of contextually-adapted brief PST for antenatal depression in rural Ethiopia, and (2) examine the feasibility of procedures of a randomised, controlled study design, to inform a future, fully-powered randomised controlled trial (RCT).

Setting

We conducted the study in purposively selected PHC facilities in Bui and Kella districts, located in the eat Gurage zone of Central Southern Ethiopia, approximately 100-120km south of Addis Ababa, the capital of Ethiopia. The official language of the region and in both districts is Amharic. In both study areas, the Programme for Improving Mental Health carE (PRIME) (45) study previously worked with local leaders and stakeholders to develop and implement a task-shared mental health care plan delivered in primary and maternal health care settings.

The PHC facilities were staffed by nurses, midwives, and health officers. Each facility was linked to about five health posts: community-based health facilities staffed by health extension workers (HEWs). HEWs are community-based HCWs who provide the first antenatal contact, before referring women for further antenatal care (ANC) at a health center or primary hospital and maintain contact with women during pregnancy.

Study design

We conducted a randomised, controlled feasibility trial with two parallel groups and two time point assessments: at baseline and nine weeks after randomisation (46). We compared adapted PST with enhanced usual care (EUC). A second feasibility trial involving a sub-sample of trial participants who reported past-year exposure to intimate partner violence was nested within the trial; as detailed in the published trial protocol (47, 48).

Participants

Study participants were required to be pregnant women attending ANC services in PHC facilities. Women were eligible to take part if they: (1) endorsed elevated and disabling depression symptoms (scoring 5 or more on the locally validated Patient Health Questionnaire (PHQ-9) (49) and endorsed impaired functioning on the 10th PHQ-9 item about functional impact), (2) were aged 16 years and above, as this is the age at which married adolescent women become legally autonomous in Ethiopia, (3) were between 12 and 34 weeks gestation of pregnancy, (4) spoke Amharic (the official regional language), (5) planned to live in the study area for at least the next six months.

Women were excluded from the study if they: (1) had a condition that impaired their capacity to understand the interview (e.g. were diagnosed with severe intellectual disability or dementia), (2) presented with acute medical illness or evidence of severe mental illness, or (3) had other comorbid medical conditions such as hypertension or renal disease or diabetes, (4) endorsed the 9th item of the PHQ-9 indicating risk of suicide and scored more than 17 on the suicide schedule of the Mini International Neuropsychiatric Interview (MINI) (50), or (5) required emergency treatment.

Participant recruitment and screening

We recruited consecutive women attending PHC-based ANC in two primary care facilities from the beginning June 2021 for 20 working days. Research staff checked the initial eligibility of antenatal attendees based on information available from their clinical records (gestation, age, co-morbid conditions, residence). Eligible women were invited to provide informed consent to an initial screen for depressive symptoms associated with disability using the PHQ-9 and the PHQ-9 tenth item on functional impact. This item asks “Over the last two weeks, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?” Options are: “not difficult at all”=0, “somewhat difficult”=1, “very difficult”=2 or “extremely difficult”=3. The suicidality schedule of the Mini International Neuropsychiatric Interview (MINI) was administered to women who endorsed any frequency of suicidality on the ninth PHQ-9 item. Women at risk of suicide (scoring over 17 on the MINI) (50) were excluded from the study and referred for review by a mental health-trained primary care worker (51) who employed the WHO mhGAP intervention guide(52) to assess the risk of suicide and provide an intervention. Research staff were trained to facilitate women’s attendance at services if referred; transportation costs to access care were covered by the study.

Any woman who was eligible to take part following the initial screen received written and verbal information about the study from research staff and thumb printed on the consent sheet; underwent a structured baseline interview after receiving routine clinical care. Participants’ costs incurred to attend research interviews and PST sessions were reimbursed and time spent during research interviews was compensated. Time spent attending PST sessions was not compensated to avoid incentivising engagement with the intervention. Healthcare workers were compensated for attending training, supervision, and delivering sessions.

Sample size

Fifty participants (25 in the intervention and 25 in the EUC group) were recruited for this feasibility trial. A sample size of 24–50 is recommended for feasibility studies (53). The estimated sample size enabled us to detect a dropout rate of 7% with a 95% confidence interval and a 5% margin of error (54).

Randomisation, allocation concealment and masking

Women with disabling antenatal depressive symptoms were randomised to one of two arms (the PST or EUC) using simple randomization in a 1:1 ratio. A random number list was generated by the trial statistician (GM) who was independent of staff working in the field. This list was held centrally at Addis Ababa University. Upon recruitment and completion of baseline assessment, a data manager in the Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), external to the study, was telephoned and allocated each participant to a study arm (PST or EUC). The person contacting the data manager was a member of the research team based in Sodo/Kella and,not involved in assessments. Whenever a new participant was allocated to PST, research staff informed a clinician trained to deliver that arm. Intervention and control groups were anonymously coded so that data analysts remained masked to allocation status during analysis. Participating women and HCWs were not masked to allocation status due to the nature of the intervention; however, outcome assessors were masked to allocation status.

PST Intervention

PST is a commonly used psychotherapy (38, 55) that has comparable efficacy to other psychotherapies such as behavioural activation, cognitive behavioural therapy and to antidepressant medication (56, 57). Assuming circular causality between social adversities and depressive symptoms (58) the PST teaches problem-solving and coping skills (58) in three phases. We adapted PST from the South African evidence base while involving the authors (KS and BM) (34). In the first phase of our adapted PST, women are guided to identify the most important things in their life. In the second phase, they identify a list of problems that challenge attainment of important goals in their life and classify problems into three categories: ‘problems that are upsetting but not relevant to the most important things in one’s life’ (Group A), ‘problems that are important but insoluble’ (Group B) and ‘important and soluble problems’ (Group C). The details of the adaptation procedures and adaptations for this study have been published (35).

The adapted PST consisted of a PST providers’ training manual, training slides, training guides, in-session flip chart resource and session record forms. Participants randomised to the intervention arm received four individual sessions of the locally adapted and manualised PST from a trained, supervised ANC provider, along with EUC. Intervals between sessions ranged from a minimum of two days (for women whose delivery approached) to a maximum of two weeks over a period of eight weeks.

Trained healthcare workers delivered the intervention under the supervision of an Ethiopian clinical psychologist and a psychiatrist trained in psychological therapies. Five days of training in the adapted PST was delivered to the healthcare workers. Training was spread over two blocks of weekdays: one block of two and one block of three days. Care was taken to accommodate Ramadan, orthodox Easter and the Election. Ministry of Health directive on COVID-19 was followed.

Healthcare worker training consisted of: (a) a five-day classroom-based training course which included training on counselling and communication skills as well as PST-specific skills, and (2) accelerated delivery of four sessions of PST, using high-intensity supervision and feedback to build competency (59, 60). Lectures, demonstrations through facilitator role plays and small group activities were employed to make the training interactive.

Competency of providers was established using the Enhancing Assessment of Common Therapeutic factors (ENACT) scale (59, 60) administered by trained clinicians otherwise independent of the study. The healthcare workers were expected to score level 3 (“Done Well”) out of the three levels: (“Done Well”, “Done partially” and “Need improvement”) on each of the competencies. All intervention sessions were audio-recorded. Random selections of sessions were assessed by an expert. A fidelity checklist (61) was adapted and used to assess the random sample of session audio records. Supervisors provided healthcare workers with feedback on audio recorded sessions focused on intervention fidelity and core competencies in PST and communication skills.

Enhanced usual care

Participants randomised to EUC received usual ANC which focuses on advice about reproductive and family health and information about sources of support. In addition, the Federal Ministry of Health in Ethiopia has prepared evidence-aligned guidelines on how to care for mental health problems in PHC and maternal care settings (62). According to the guideline, PHC staff are expected to detect mental health problems and to provide basic mental healthcare (non-specific psychosocial care for all and supervised prescription of antidepressant medication depending on severity) (63). All HCWs participating in the trial had been trained in the World Health Organisation’s mhGAP intervention guide for a minimum of five days, as per the mental health scale-up plans of the Federal Ministry of Health. As the mhGAP-IG had not been implemented at scale in Ethiopia, this represented an enhancement in usual care (64, 65).

Participants allocated to EUC and their HCWs were informed about the results of screening and received a leaflet about well-being in pregnancy and sources of support. These women attended two contacts: the one pre-randomization baseline assessment and the follow-up assessment nine weeks after randomisation.

Baseline assessment

Baseline assessment measured: (1) demographic information, (2) Trial outcome variables (clinical outcome measures and potential hypothesized mediating variables) and (3) trial feasibility parameters (acceptability, fidelity and quality of PST training, participant recruitment and randomisation, data collection procedures and intervention delivery).

Demographic information comprised age, education, marital status, age at marriage, husband’s occupation and educational level, type of residence and pregnancy intention), obstetric history, including parity, pregnancy intention, and gestational age, past psychiatric history and list of traumatic experiences at baseline. We used an item from Ethiopian Demographic Health Survey which we had previously used in our setting (16) to assess pregnancy intention.

Main trial outcomes and hypothesised mediators

Assessments of outcome variables and hypothesised mediators were conducted at two time points: pre-intervention (T0; baseline) and nine weeks after randomisation (T1; follow-up). A third time point assessment had been proposed, at the protocol stage, to take place at 3 months post-partum. This was not carried out due to disruption related to the COVID-19 pandemic and civil conflict.

We piloted the potential primary outcome for a future, fully-powered RCT to assess efficacy of using the locally validated Amharic version of PHQ-9 (66). The PHQ-9 has been widely used as a clinical outcome measure of treatment for depression (67, 68). In Ethiopia, PHQ-9 has been validated in antenatal women (69) and in PHC settings in the neighboring district of the current study. The optimal score cut-off indicating probable depression in this context has been identified as five or more in PHC (49). At that cut-off, PHQ-9 had a sensitivity of 83.3% and specificity of 74.7% for detection of major depressive disorder. In previous studies, a 50% reduction in PHQ-9 depressive symptom scores (68) after 6–8 weeks was defined as treatment response.

We piloted potential secondary clinical outcome measures for a future RCT: Generalised Anxiety Disorder-7 scale (GAD-7 (70)), WHO Disability Assessment Scale (WHODAS (71)), post-traumatic stress disorder (PTSD) checklist for DSM-5 (PCL-5 (72, 73)).

We piloted the following measures of hypothesised mediators of PST’s effects: a five item ‘non-graphic language’ scale for intimate partner violence (IPV) (74) and the WHO multi-country study screen (75) for intimate partner violence exposure, the WHO attitudes towards gender roles scale (76), a translated multicultural mastery scale (77), a an adapted self-efficacy scale (77), the stressful life events scale (78) locally adapted Client Service Receipt Inventory (CSRI) (79) measuring the number of emergency healthcare visits and costs and the Oslo Social Support Scale (OSS-3), previously used in Ethiopia (80).

Feasibility parameters

Feasibility parameters comprised the feasibility of provider training, participant recruitment such as challenges in privacy and ethics of screening and randomisation, data collection procedures (layout, instructions, order of assessment tools), running outcome assessments and intervention delivery and acceptability of the intervention and trial procedures.

We collected both quantitative and qualitative data to examine these parameters. Quantitative data comprised: percentage dropping out of the study, number of HCWs who were competent as assessed by the ENACT scale, independent assessments of session fidelity, rates of recruitment, eligibility and agreement to screening and randomisation. Quantitative data also included the standard deviation of outcome measures and time taken to complete baseline and outcome assessments.

We assessed the acceptability of the intervention and trial procedures using qualitative data obtained from proceedings of the supervision and health worker supervision record notes and embedded supervisor notes in session fidelity and completion checklist. The supervisors were supposed to make face to face supervision after they had completed the HW supervision records and independent fidelity checklists. In four face-to-face supervisions, the supervisors have recorded proceeding notes. The issues included in the notes were related to each of the items in the HW supervision records and independent fidelity checklists. Supervisors were two clinicians who had engagement on PST adaptation workshops, theatre test and in trainer of trainers of the PST. We also employed in-depth interviews with HCW and selected participants post-trial (to be reported in a forthcoming process evaluation). Reports of qualitative data obtained from the supervision and session fidelity and completion checklist notes are reported in this report.

Data quality

We trained research assistants to become familiar with the nature and type of data to be collected. All baseline and outcome assessment tools were entered into the electronic Open Data Kit (ODK) programme at the time of collection.

Data analysis

Trial outcome measures

We calculated descriptive statistics to summarise the main trial outcome assessments at both time points for PST and EUC arms using STATA version 16. For continuous outcomes, we calculated standard deviations to inform future sample size calculations for a fully powered RCT for all participants for whom data were available (complete case analysis). The proportion of each group meeting criteria for treatment success (a 50% reduction of PHQ-9 score at T1) was described for the two arms.

Feasibility parameters such as acceptability, fidelity and preliminary efficacy of: participant recruitment, randomisation, masking, assessment procedures and intervention delivery were summarised using both numerical and text descriptions. We used descriptive tables and graphs to compare the two arms both at baseline and follow up. Finally, we adhered CONSORT Checklist (81) to report the findings of the feasibility trial.

Ethical considerations

Our feasibility trial protocol was registered on the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020;

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578. We received ethical approval from the scientific committee of CDT-Africa and the Institutional Review Board of Addis Ababa University, College of Health Sciences (IRB reference: 049/19/CDT). All participants provided written (thumbprint for non-literates) informed consent. Clinical records and consent forms were stored in a locked research office for confidentiality. Research staff checked for unreported adverse events by using telephone contacts to follow up participants who had withdrawn without reporting to the research office. i

Feasibility of participant recruitment and randomisation

Feasibility of recruitment was evidenced by research assistants approaching a total of 335 potentially eligible pregnant women over 20 working days (17 women per day). Nearly half n = 154 (46%) of women approached met eligibility criteria after pre-screening. The remaining n = 181 were ineligible (48%, n = 87 were in late gestation; 23%, n = 41 did not plan to continue living in the area; 20%, n = 37 did not speak Amharic; 13%, n = 23 were too unwell; 1%, (n = 2) did not understand the information provided and 0.5% (n = 1) was under 16 years old (Fig. 1).

Of the 154 potentially eligible women who were screened, 56 women scored below five on the PHQ-9, 11 women were excluded because recruitment targets had been met, only 12 declined to participate. Finally, n = 25 consented women were randomized to the third arm nested in this study. The remaining 50 eligible women all consented to participate and randomized to the two parallel arms. Among women randomized in the PST arm, 64% of them attended all the intervention sessions.

Table 1

Participant socio-demographic characteristics at baseline
				Allocation to study arms
Socio-demographic characteristics:		N = 50 Total N (%)		N = 25 PST n (%)		N = 25 EUC n (%)
Marital Status	Single (never married)	1 (2)		1 (4)		0 (0)
	Monogamous marriage	48 (96)		24 (96)		24 (96)
	Polygamous marriage	1 (2)		-		1 (4)
Educational status	Non-literate	12 (24)		7 (28)		5 (20)
	No formal education	4 (8)		0 (0)		4 (16)
	Primary level only	19 (38)		14 (56)		5 (20)
	Secondary level only	8 (16)		3 (12)		5 (20)
	Higher education	7 (14)		1 (4)		6 (24)
Occupation	Housewife	29 (60)		16 (64)		14 (56)
	Daily laborer	3 (6)		2 (8)		1 (4)
	Farmer	4 (8)		2 (8)		2 (8)
	Merchant/trader	7 (14)		5 (20)		2 (8)
	Self/ Government employee	5 (10)		0 (0)		5 (20
Parity	Nulliparous	18 (28)		7 (44)		11 (44)
	Primiparous	12 (32)		8 (16)		4 (16)
	Multiparous	20 (40)		10 (40)		10 (40)
Pregnancy intention	Unintended	12 (24)		6 (24)		6 (24)
Pregnancy intention	Intended	38 (76)		19 (76)		19 (76)
stressful life events	None	17 (34)		7 (29)		10 (40)
stressful life events	One or more	32 (65)		17 (71. )		15 (60)
Summary of continuous variables			(mean, SD)		(mean, SD)
Age			(27.1, 6.2)		(26.4, 6.1)
Age at Marriage			(20.2, 3.4)		(20.0, 3.5)
household size			(4.1, 2.0)		(4.5, 2.5)

Almost all (n = 49, 98%) participants were married, 38% had completed primary level education, 56% were housewives, 40% multiparous, 76% had intended to become pregnant and 65% had experienced one or more stressful life events within the last six months (Table 1). The average household size was 4.1 and 4.5 for PST and EUC arms respectively. The average age at the time of marriage was 20.2 and 20.0 years for PST and EUC respectively. The average age of participants was 27.1 and 26.2 years in the PST and EUC arms respectively.

Feasibility of data collection procedures and outcome measures

The layout, instructions and order of assessment tools were acceptable. There were no challenges in privacy and ethics of screening participants or carrying out outcome assessments. It was possible to mask outcome assessors and those carrying out data analysis. No missing data were reported for baseline and outcome assessment measures.

The primary and secondary clinical outcome measures for the PST and EUC arms are presented in the Fig. 2. Out of women followed up, a greater number of women in the PST arm (67%) fulfilled the definition of treatment success (response; 50% reduction in PHQ-9 score) compared to women in the TAU arm (60%). However, more women in the EUC arm (40%) no longer met criteria for depression than women in the PST arm (33%) post-intervention. There was no consistent difference in arms in terms of response, remission or mean score on PHQ-9. At follow up, the mean PHQ-9 score was slightly higher among the EUC groups compared to the PST. The mean GAD-7 and PCL-5 scores were lower for the PST arm compared to the EUC post intervention at follow up. The increasing slope of the GAD-7 and PCL-5 mean scores in the EUC arm and the negative slope for these variables in the PST arm potentially suggests that the positive role of PST on these outcome measures.

Mean perceived social support appeared to increase more for the PST arm than the EUC arm post-trial, but self-efficacy appeared to increase more in the EUC than the PST arm. The mean IPV score appeared to be slightly lower for the PST arm compared to the EUC arm both baseline and follow up assessments.

The mean multicultural mastery score increased from baseline to follow up for the PST arm while it decreased for the EUC arm. Mean WHODAS scores decreased from baseline to follow up in both arms.

Table 2

Change in outcomes across the study arms
OUTCOME:	Assessment time	PST Arm: mean, SD	TAU arm (mean, SD)
PHQ-9 Score	Baseline (n = 25)	8.48, 2.22	8.16, 2.79
PHQ-9 Score	Outcome (n = 18)	4.60, 5.30	3.80, 5.12
Generalised Anxiety Disorder-7 scale score	Baseline (n = 25)	9.72, 4.54	9.32, 3.01
Generalised Anxiety Disorder-7 scale score	Outcome (n = 18)	9.11, 2.47	9.70, 5.66
WHO Disability Assessment Scale score	Baseline (n = 25)	25.04 5.98	24.84, 5.94
WHO Disability Assessment Scale score	Outcome (n = 18)	22.72, 9.63	23.35, 9.09
PTSD symptom checklist score	Baseline (n = 25)	9.84, 15.23	5.36, 6.14
	Outcome (n = 18)	4.00, 5.87	7.65, 12.08
Non graphic language IPV scale score	Baseline (n = 25)	2.52, 3.11	2.68, 2.35
Non graphic language IPV scale score	Outcome (n = 18)	2.50, 3.70	2.65, 4.28
Perceived Social support	Baseline (n = 25)	10.92, 1.93	10.60, 2.14
	Outcome (n = 18)	11.17, 2.00	10.65, 1.89
Efficacy of coping depression scale score	Baseline (n = 25)	13.64, 5.85	13.76, 5.79
Efficacy of coping depression scale score	Outcome (n = 18)	14.72, 5.94	16.4, 4.56
Multicultural Mastery scale score	Baseline (n = 25)	31.88, 6.72	33.28, 6.83
Multicultural Mastery scale score	Outcome (n = 18)	35.05, 5.42	32.9, 8.38
Attitude towards gender roles scale score	Baseline (n = 25)	27.08, 21.41	25.72, 6.48
Attitude towards gender roles scale score	Outcome (n = 18)	23.39, 4.30	25.20, 5.04

Feasibility of intervention delivery

Appropriateness

Supervision notes consistently indicated that coping strategies such as ‘worry time’, thinking stop and relaxation exercises were beneficial, supporting the appropriateness of the problem-solving therapy both from the perspectives of providers and service recipients. Nevertheless, the timing of childbirth prevented some participants from completing all four intervention sessions or attending outcome assessments nine weeks post-randomisation. This arose because of the cultural practice of postnatal confinement for 10–21 days in the family home.

Table 3

Time taken for each session
Session	session duration
Session	Minimum	Maximum	Mean	Number of sessions timed
Session 1	0:21:05	0:56:00	0:40:45	10
Session 2	0:37:00	1:09:00	0:47:48	7
Session 3	0:16:14	0:58:42	0:40:53	15
Session 4	0:34:00	0:45:00	0:37:39	4

On average, all sessions took longer than the expected 30 minutes, especially session 2 (mean: 47.5 minutes) (Table 3).

Provider competency

PST training was completed with no staff dropping out. Training feedback indicated that HCWs generally appreciated the intervention and training methods. Audio-recorded sessions-based regular supportive supervision and feedback received from the trainer supervisors gave the HCWs the opportunity to discuss challenging cases. HCWs were supposed to score 3 in each of ENACT items as a test of their competency during their accelerated training (Table 4). However, an average of only 58% of the HCWs scored three in each ENACT item. Most HCWs were independently rated as competent in verbal communication skills (n = 19 sessions out of 36 rated), building trust (n = 30 out of 35 sessions rated), empathy, warmth and genuineness (n = 28 out of 35 sessions rated) and promotion of realistic change (n = 33 out of 35 sessions rated) or used local terms when delivering the intervention (n = 11 sessions out of 14 rated). However, relatively few HCWs (n = 7 out of 35 sessions rated) explained confidentiality to women, or asked for feedback and suggestions (n = 17 out of 35). HCWs also scored lower for exploration, interpretation and normalisation of women’s feelings and in assessing recent life events’ effect on women’s well-being.

Table 4

ENACT scores of HCWs across sessions (**Total N = 36)**
	Frequency for Options of ENACT items
Building relationship	Needs improvement	Partially Done	Well Done	Total
Verbal communication skills	1	16	19	36
Building Trust	0	5	30	35
Explaining confidentiality	20	8	7	35
During intervention skills
Exploration, interpretation and normalization of feelings	0	20	16	36
Empathy, warmth and genuineness	0	7	28	35
Promotion of realistic hope for change	0	2	33	35
Use of local terms in delivering the intervention	0	3	11	14
Asking for feedback and suggestions	2	16	17	35
Assessment skills
Assessing recent stressful life events	0	14	18	32
Assessing problems solving skills	2	6	26	34
Harm to self, harm to others, and harm from others	15	8	4	27
Assessing potential community or social networks	6	6	8	20
Total	46	111	217	374
Ratio of ENACT item options to total sessions	12.3	29.7	58.0	100.0

The ANC staff was over-stretched during the COVID-19 pandemic at the time of training. For example, the trial coordinator reported her observation of two HCWs attending the training getting tired after their workload on the night shifts. Supervisors noted that the quality of sessions and fidelity to the intervention increased as health workers gained more experience.

HCWs reported that the use of face masks in a large room without microphones lowered the audibility of the trainers. Trainees also reported that trainer demonstrations of sessions could have been shortened, increasing time for trainee role plays and practical exercises.

Although several HCWs adhered to the intervention procedures, supervisors reported that some HCWs needed more practice to improve basic counselling skills, including reflective listening, expressing empathy and asking open ended questions without directly advising women:

“More practice of basic counselling skills; reflective listening, empathetic understanding has been advised. Directives/advising which doesn’t exist in the PST protocol should be minimised”, Supervisor

Supervisors noted that HCWs forgot to explain the content of each session, mixed up problems and the most important things in life or omitted to ask about the most important things in the lives of participating women. One supervisor noted poor preparation by some HCWs:

“He has attended the standard PST [training]. I have no concern about delivering PST but due to his low preparation when delivering this session, he has committed confusions when he explains issues. For example, he explains the ‘most important things in your life as ‘most significant concerns in life”, Supervision notes.

“Yes, she has attended the standard PST [training] but she did not outline the three phases of PST at the beginning.”, Supervision notes.

“Yes, [one] HCW was reading a lot from [the] flipchart which indicates limited preparation”, Supervision notes.

The supervisor noted that HCWs experienced difficulties when women could not suggest any solutions for their problems:

“I felt hopeless unable to help her solve the problem she is in. Recording is pointless for me at this point; I want to help/support those mothers even in the future. I mean what is the point of giving her the session if she is not going to have some sort of solution at the end of the day (she came for the second session looking nice though)” Supervision notes.

“A mother who was unable to speak about her problem and come up with a solution, I was in a situation where I had to do all the talking. What to do in such cases?” Supervision notes.

Provider fidelity

Trainer supervisor notes indicated that several HCWs implemented PST as planned (“generally, depression during pregnancy was not mentioned, otherwise this HCW had done a great job to implement PST”). Supervisors praised HCWs’ adherence to session introductions, such as introducing PST and discussing confidentiality. However, during independent fidelity assessment, supervisors noted that some aspects of intervention content were not adhered to in certain circumstances, for example when participants responded that they had no problems. Supervisors noted that this usually occurred when initial explanations and inquiries had been brief; they encouraged HCWs to explore women’s lives further in such situations. One supervisor commented that some HCWs emphasised the six steps of problem solving and overlooked other therapeutic skills such as breathing exercises.

One HCW admitted that they skipped and forgot some elements and procedures of PST for the first woman they treated; challenged whether to give the women additional homework if homework for the preceding session had not been completed. However, this improved for the second and third women they engaged with. The independent fidelity assessors noted that some HCWs struggled to categorise women’s worries and concerns when they were all linked to poverty or problems with their husbands. For example, one participant said: “once I am financially secure, everything will be fine”. Supervision notes indicated that thanking the woman for her attendance, helping women to identify their problems, defining problems and clarifying the purpose of audio recording were well done.

Acceptability

HCWs were compensated 2000 birr (37 USD) per woman who received the intervention, including training and supervision attendance. Pregnant women were reimbursed 70–140 birr for travel expenses incurred by attending sessions. Dropping-out of the study for reasons other than moving away from the study site were infrequent. Supervisors also reported their observation in supervision notes about HCW feedback. Most HCWs were happy in taking part in delivery of PST and gaining its skills:

“We are happy for getting additional skills, PST and basic counseling. We are pleased to work counselling for a woman in need. Because of PST, we admitted our deficiency of counselling skills and the training and practicing PST creates an insight for this. We are seeing progress-happy faces of woman, even with 2 or 3 sessions. So, we want to use [it] for our routine practice in the future.”, HCW views from supervision notes.

“Yes, she [HCW] found that the training is an additional useful skill to her routine activities. Since she is not familiar with this kind of psychosocial training, more rehearsal and preparation was recommended. No concern reported about delivering PST”, Supervision notes

Engagement

Supervisors observed that women sometimes became distracted by their children during sessions (“The baby of the women has been very distracting throughout the session”, Supervisor). Although Amharic is the official language of the region some participants did not seem confident to speak in Amharic during sessions. One HCW worker mentioned that some women just cried, but most spoke up if spoken to in their local language:

“Generally, the sessions with this participant doesn’t go very well which might be due to language barrier. She has been frequently talking in her local language and the HCW frequently requested her to speak in Amharic language. The HCW did not well internalise the structure of PST. Thus, he did not adhere to the structures of the PST as presented at the flipchart”, Supervision note.

While several women spoke about their problems, some HCWs reported that women denied problems once the audio recording of the session started: “I had to let go (didn’t record the first session) one mother who declined to take part saying she has no problem”. HCWs pointed out that women’s fear of their private matters being exposed to third parties was the reason refusing to disclose their problems:

“They tell me lots of deep personal issues after we finish the session and the audio recorder is off. When we ask the problem they have most people automatically go to the economical/financial problems they have. Maybe the more we talk to them and explain they will tell us the other problems we are looking for”, HCW.

Some HCWs asserted that some women required lots of probing before opening up. Some HCWs reported confusion about the need to continue intervention sessions for women who engaged with problem solving in early sessions. Some participating women came to the health center from remote areas and were in a hurry to complete sessions. For example, one HCW asserted that she worried about making the woman late and rushed during sessions while giving information and direction,

Fidelity checklists indicated that most HCWs encouraged the women to join the discussion by thanking them. However, some HCWs did not provide encouragement. In the middle of the first session, HCWs engaged women in identifying, explaining and categorising their worries and concerns into three types of problems (“yes, she well engaged the woman here [in categorising the problem]”. Nevertheless, the supervisor commented that some HCWs were not actively listening and recording women’s worries and problems:

[The HCW] disregards some of the reported problems. At this point, she was directive and deliver guidance and advising instead of identifying worries and problems.

The aspects where there were lowest levels of fidelity were thanking the participant for attending sessions, choosing the problem that can be changed and working through the six problem solving steps, outlining the three phases of PST and explaining the take home activity. For example, one upervisor noted that some HCWs did not introduce and explain the six-step approach while others focused on lecturing about the six-step approach instead of practicing it to solve women’s identified problems (“she didn’t introduce the six steps approach”).

Safety

No serious adverse event (SAE) or adverse events occurred during the trial. Clinical records and consent forms were stored in a locked research office for confidentiality. Research staff used telephone contacts to follow up participants who withdrew without reporting to the research office, in order to check for unreported adverse events.

The importance of tailoring existing evidence-based interventions for the context where they will be delivered is increasingly acknowledged (31, 43, 82). We adapted PST for women with antenatal depression in a rural Ethiopian setting (35) where there is a large mental health treatment gap linked to high social adversity. In this study, we demonstrated the feasibility of trial procedures and the possibility of integrating four sessions of PST into ANC in rural Ethiopia. We explored potential contextual factors and causal mechanisms that may influence intervention delivery procedures. This is an essential step towards planning a future fully-powered RCT.

The feasibility of participant recruitment and randomisation was evidenced with our ability to approach 17 women per day, of whom nearly half met eligibility criteria. Randomization to PST and EUC arms was feasible and acceptable, as were masking outcome assessors and investigators to allocation status as well as baseline and outcome assessments nine weeks later. Although this feasibility study was not powered to evaluate effectiveness, changes in mean clinical outcome scores such as GAD-7 and PCL-5 and hypothesised mediators (perceived social support, self-efficacy, mastery) favoured the PST arm over EUC.

Some of the challenges that might have affected the feasibility of the intervention and its preliminary effectiveness include: 1) women’s attribution of problems to either poverty or problems with their husbands, 2) women becoming distracted by their children, 3) women’s confidence to discuss in Amharic and/or audio recording, 4) HCWs’ focus on recording women’s worries instead of listening and 5) the cultural practice of postnatal confinement limiting some participants from completing all four sessions or attending an outcome assessment.

Each PST session lasted an average of 41 minutes which was longer than intended (83). The session content may need to be reduced to enable this intervention to be integrated into ANC. Techniques such as ‘worry time’ and relaxation exercises were appreciated, supporting the appropriateness of the PST model. Most (64% of women in the PST arm) attended all the intervention sessions. Participants’ dropping –out of the study for reasons other than moving away from the study site were rare and acceptability of the intervention was increased through integration into existing ANC in PHC facilities. Feasibility of training and provider competency were evidenced by HCWs’ completion and appreciation of training, with no drop-outs. Several HCWs could implement PST as planned. For example, supervisors praised HCWs’ adherence to session introductions. The intervention was shown to be safe where there was no serious adverse event (SAE) or adverse events occurred during the trial.

However, only an average of 58% of HCWs attained the expected ENACT score, indicating lower than expected competency which supports previous findings in the same setting in Ethiopia (84). Perhaps this points to the need to consider eligibility criteria to be established for providers, or some sort of apprenticeship/pre-trial assessment. Ensuring provider fidelity and competency remains a common challenge of task-sharing. Our finding of poorer than expected competency, despite accelerated case training and rigorous supervision, supports previous studies in Ethiopia (84). However, our findings about improved provider skills across sessions is supported by similar findings in Kenya (85) which explains the role of experience and practice-based training for the development of new skills.

Internalising the structure and concepts of PST may require more intensive training and supervision. However, COVID-19-relatedpressures and clinically overloaded ANC HCWs in the area were barriers. Faster than anticipated recruitment of eligible participants led to referral of participants for sessions as soon as HCWs had completed accelerated cases, limiting the time available for in-depth supervision, reflection and learning from those cases. Long trainer demonstrations of role plays could be improved by introducing video recorded role play demonstrations followed by more time for trainee role play practice.

The faster rate of recruitment than expected is explained by a relatively high prevalence of disabling perinatal depressive symptoms (86) and wide treatment gap in the study area (87) supporting the importance of contextualizing psychological interventions. The feasibility of trial procedures such as randomisation, masking and acceptability of outcome assessments is explained by care taken to plan a study design acceptable to this context(46). Positive preliminary effectiveness of the intervention on mental health outcomes and hypothesised mediators can be explained by improved HCW skills of the empathetic, supportive and compassionate care to participants. Despite a small sample, bigger improvements in the intervention arm in anxiety and PTSD symptoms relative to depression is an interesting finding indicating the potential that depression symptoms may be linked to traumatic experiences. Training HCWs to deliver this rigorously contextualised intervention (35) may have improved women’s experiences of supportive and compassionate ANC. Our study was limited by compensating HCWs, which may have impacted their motivation to follow the intervention manual.

Recruitment, randomisation and concealment of participants and the intervention delivery process were feasible. Future efficacy trials should consider the lessons obtained from this feasibility study like consideration for future trial to reduce gestational age for recruitment.

ANC: Antenatal care

CDT-Africa: Center for Innovative Drug Development for Therapeutic Trials – Africa

DSM-IV: Diagnostic Statistical Manual–IV

EUC: Enhanced Usual Care

ENACT: Enhancing assessment of common therapeutic factors

GAD-7: Generalized Disorder Anxiety

HEWs: Health extension workers

MINI: Mini International Neuropsychiatric Interview

MhGAP: mental health Gap Action Programme

PCL-5 PTSD Checklist for DSM-5

PHC: Primary health care

PHQ-9: Patient health questionnaire-9

PST: Problem solving therapy

PRIME: Programme for Improving Mental Health carE

ODK: Open Data Kit (programme)

OSS-3: Oslo Social Support with 3 items

RCT: Randomised controlled trial

SNNPR: Southern nations and nationalities and peoples’ region

SAE: Serious Adverse Event

WHODAS: World health Organization disability scale

Ethics approval and consent to participate

Our feasibility trial protocol was registered on the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020;

Consent for publication

Not applicable

Availability of data and materials

The datasets generated and/or analysed during the current study are not publicly available until we could publish the forthcoming study, but are available from the corresponding author on reasonable request.

Competing interests

Investigators contributing to this work were supported by Debre Markos University and Injibara Universities (TB), a King’s IoPPN Clinician Investigator Scholarship (RK); the NIHR Global Health Research Group on Homelessness and Mental Health in Africa (NIHR134325) and the SPARK project (NIHR200842) and Wellcome Trust (222154/Z20/Z and 223615/Z/21/Z) to CH; joint research grant funding from the Medical Research Council (MRC), Wellcome Trust NIHR and United Kingdom’s Department for International Development (MR/M014290/1; MR/R018464/1) (KS, BM).

Funding

This work received funding from the United Kingdom’s National Institute for Health and Care Research (NIHR) as part of the NIHR Global Health Research Unit on Health System Strengthening in Sub-Saharan Africa (ASSET), King’s College London (GHRU 16/136/54) (CH, RK, TB) using UK aid from the UK Government. The work was also funded through the DELTAS Africa Initiative [DEL-15-01] (TB, CH, KS), an independent funding scheme of the African Academy of Sciences’ Alliance for Accelerating Excellence in Science in Africa, with support from the New Partnership for Africa’s Development Planning and Coordinating Agency with funding from the Wellcome Trust and UK government.

In addition, investigators contributing to this work were supported by Debre Markos University and Injibara Universities (TB), a King’s IoPPN Clinician Investigator Scholarship (RK); the NIHR Global Health Research Group on Homelessness and Mental Health in Africa (NIHR134325) and the SPARK project (NIHR200842) and Wellcome Trust (222154/Z20/Z and 223615/Z/21/Z) to CH; joint research grant funding from the Medical Research Council (MRC), Wellcome Trust NIHR and United Kingdom’s Department for International Development (MR/M014290/1; MR/R018464/1) (KS, BM).

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health and Care Research or the Department of Health and Social Care, England, or any other of the funders.

For the purposes of open access, the author has applied a Creative Commons Attribution (CC BY) licence to any Accepted Author Manuscript version arising from this submission.

Authors' contributions:

Conceived the study (TB, RK, HC, KS, BM, FG); revised the protocol (TB, RK, HC, KS, BM, SH, GM, LH), took part in data collection: TB, RK, HC, KS, BM, EF, AM; took part in data analysis TB, RK, HC, KS, BM, GM; wrote the first draft TB, RK, HC, KS, BM. All co-authors read the manuscript.

Acknowledgements

We would like to thank all participants, Sodo and Kella district health officials for their technical support to attain this study.

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Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: randomised, controlled feasibility trial in primary care in rural Ethiopia

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Abstract

Figures

Key messages regarding feasibility

Background

Methods

Setting

Study design

Participants

Participant recruitment and screening

Sample size

Randomisation, allocation concealment and masking

PST Intervention

Enhanced usual care

Baseline assessment

Main trial outcomes and hypothesised mediators

Feasibility parameters

Data quality

Data analysis

Trial outcome measures

Ethical considerations

Results

Feasibility of participant recruitment and randomisation

Feasibility of data collection procedures and outcome measures

Feasibility of intervention delivery

Appropriateness

Provider competency

Provider fidelity

Acceptability

Engagement

Safety

Discussion

Conclusion

Abbreviations

Declarations

Ethics approval and consent to participate

Consent for publication

Availability of data and materials

Competing interests

Funding

Authors' contributions:

Acknowledgements

References

Supplementary Files

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