Evaluating effects of Community-based Social Healing Model on Ubuntu, mental health and psychosocial functioning in post-genocide Rwanda: Protocol for Cluster Randomized Control Trial

doi:10.21203/rs.3.rs-4790345/v1

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Evaluating effects of Community-based Social Healing Model on Ubuntu, mental health and psychosocial functioning in post-genocide Rwanda: Protocol for Cluster Randomized Control Trial

https://doi.org/10.21203/rs.3.rs-4790345/v1

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Background: The Community-Based Social Healing (CBSH) model by Ubuntu Centre for Peace aims to help those with traumatic experiences and mental health issues achieve better mental health. CBSH integrates BREATH-BODY-MIND™ (BBM) practices with collective narrative and rituals through Community Healing Assistants in therapeutic groups. An earlier pilot study showed significant mental health improvements among1,889 Rwandans who participated in the CBSH, including reduced depression, anxiety, and PTSD, improved work productivity and decreased intimate partner violence. The trial focuses on CBSH’s impact on Ubuntu This trial focuses on CBSH's impact on Ubuntu—a philosophy of humanness, compassion, and interconnectedness deeply rooted in the African philosophy––and mental health.

Methods/Design: This cluster randomized controlled trial, This cluster randomized controlled trial involves 54 randomly selected villages in Kirehe district, with 1080 participants allocated equally to the CBSH intervention or a wait-list control group. Outcomes are measured at the person-level, with primary outcomes being Ubuntu and mental health. Ubuntu is assessed using a context-adapted Ubuntu measurement scale. Mental health measures include the Patient Health Questionnaire for depression (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Warwick-Edinburgh Mental Wellbeing scale (WEMWS), 10-item Connor-Davidson Resilience scale (CD-RISK-10), and Patient Health Questionnaire 15-item Somatic Symptom Severity Scale (PHQ-15). Secondary outcomes include the Revised Conflict Tactics scale short form (CTS2S SHORT FORM) and the Adapted Social Capital Assessment Tool (SASCAT).

Conclusion
This Trial explores the CBSH model’s impacts on Ubuntu, mental health, and social functioning among trauma-affected Rwandans, including those impacted by the 1994 Genocide against the Tutsi, mass killings, sexual abuse, and domestic abuse. The results will be valuable for the Ubuntu Centre for Peace, policymakers, healthcare practitioners, and other stakeholders, highlighting the significance of promoting Ubuntu in addressing mental health and psychosocial trauma consequences.Top of Form

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Trial registration: ISRCTN with ID: ISRCTN17659369. It was registered on February 09, 2024.

Community-based

social healing

post-traumatic stress

Ubuntu

Mental health

mind-body

breath-based

Africa

genocide

Mental health, a key aspect of human well-being, influences thoughts, emotions, and the ability to deal with the challenges of life. Globally, 1 in 8 people are affected by mental illnesses, the most common being depression and anxiety disorders (1). Poverty, conflict, economic insecurity, political wars, urbanization, and climate change contribute to physical and mental ill-health (2). From 2000 to 2015, Africa observed a 52% increase in years lost to disability owing to mental and substance use disorders (3). Tragically, mental healthcare services delivery and utilization are scarce on the African continent. The region has approximately 99% less mental health consultation and 85% fewer mental healthcare workers than the global average (3). In Africa, mental health care is hindered by a lack of government funding, paucity of professionally trained providers, and stigmatization linked to traditional beliefs.

Thirty years have passed since Rwanda endured the atrocities of the Genocide against the Tutsis. The traumatic experiences have disturbed the social structure leaving behind psychosocial problems such as chronic fear and mistrust, social isolation and discrimination, guilt, collective angst, victimhood, and shame (4). Genocide survivors have more than double the rates of mental health disorders compared to the general population, with highest prevalence for depressive disorders (35% vs 12%) and posttraumatic stress disorder (PTSD) (27.9% vs 3.6%) (5). Also, ex-prisoner genocide perpetrators face social and family rejection, loss of social and professional identity due to long periods of incarceration, emotional suppression and hopelessness (4). Despite 62% of the population being aware of the existing mental healthcare services, only 5.3% utilize them (5). This low level of mental healthcare-seeking behaviour is a consequence of numerous barriers including lack of awareness, financial constraints, geographic access, and cultural stigma (6).

Western paradigms of mental health treatment focus more on the individual’s traumas than on communal, socio-cultural and historical aspects (7,8). In contrast, the socio-ecological model of mental health considers six levels of influence on human behaviour: individual, relationships, organizations, communities, policy, and society (9). This model aligns with the World Health Organization definition that highlights mental health as not just the absence of mental illness but also the capacity of a person to deal with stress and achieve their full potential, emotional and social well-being, resilience, and the ability to work well, thereby contributing to the community (10). The socio-ecologic model aligns with the Pan-African philosophy of Ubuntu that emphasizes the authenticity of an individual human being as part of a larger and more significant relational, communal, societal, environmental and spiritual group (11).

Ubuntu is an essential moral relational ethic in African culture that promotes right actions, values fellowship, reconciliation, friendliness, harmony, reciprocity, mutual caring, and dignity in the service of communality and justice (12). The Ubuntu way of living improves mental health by fostering social supports, nurturing environments, and peaceful coexistence (13). The quality of social relationships and supports, by increasing resilience to stress, was shown to play a significant role in decreasing depression symptoms and reducing the likelihood of developing PTSD (14,15). Additional contributors to mental healing in the context of social cooperation include empathy, emotional contagion, emotion regulation, compassion, and consoling behaviour (16–18). The African philosophy of Ubuntu, a culturally sensitive approach to the emotional and relational aspects of healing, could help close the gap in mental healthcare that persists systems that are limited to Western approaches in Rwanda and Africa.

Community-Based Social Healing (CBSH) model is a holistic intervention created by Ubuntu Centre for Peace that aims to enhance psychosocial healing and help people with mental health conditions caused by psychologically traumatic experiences including genocide, mass killings, sexual abuse, domestic abuse, and others. The CBSH integrates Breath-Body-Mind practices with collective narrative and rituals through Community Healing Assistants in therapeutic groups. A before and after evaluation of the pilot project of the CBSH intervention for 1889 participants from July 1st, 2020 to June 30th, 2021 showed significant reductions in rates of depression, anxiety, and PTSD. There was also improvement in work productivity and reduction in intimate partner violence (19). The intervention addressed trauma, mental health conditions, and relationships within families and among neighbors (19).

Breath-Body-Mind (BBM) practices restore autonomic balance, improve emotion regulation, and help resolve trauma-related symptoms through multiple mechanisms, as described by Drs. Gerbarg and Brown (16,17,20,21). Plausible mechanisms include using voluntary regulated breathing practices that activate parasympathetic pathways, reduce overactivity of the sympathetic nervous system, increase release of inhibitory neurotransmitter gamma amino-butyric acid (GABA), inhibit overactivity in the amygdala (emotion processing), and increase activity in the brain’s higher centers that mediate assessment of safety and risk, executive functions, decision-making, and interoceptions (perceptions of changes in the internal state) (16). Evidence suggests that BBM practices increase awareness of feelings, emotions, and thoughts by focusing attention and stimulating the brain's interoceptive (awareness of sensations form inside the body) pathways (20). In addition, they may stimulate pro-social neurophysiological processes that increase empathy, love, and social engagement. The net result is a positive shift in the psycho-neurophysiological state from one of defensive fear, anger, isolation, and mistrust to one in which the person feels safe, calm, connected, flexible, cooperative, and compassionate (16,17,21).

Breath-Body-Mind was chosen for the CMSH model because in previous studies and field work, including South Sudan, Uganda, and Rwanda it had demonstrated significant benefits for anxiety, depression, and PTSD, even in extremely traumatized people (22,23).

The CMSH model also incorporates local rituals, including singing, dancing and drumming which are used to create a safe space for authentic storytelling and attentive listening (24). Sharing personal narratives in a safe group setting gives participants the opportunity to re-interpret their life stories and to restore their sense of belonging, self-worth, purpose and hope (25). Therapeutic group members’ stories influence or inspire one another to challenge unhealthy perspectives and perceptions, helping to change them into healthier ones.

The CBSH model is consistent with the Ubuntu African philosophy which promotes individual wellbeing in a collective environment, supportive relationships, personal, and societal healing, and economic growth. Nevertheless, how the improvements in Ubuntu are related to mental health and other positive outcomes of the CBSH model has not been evaluated. Moreover, there is no validated, reliable Ubuntu measurement tool that reflects Rwandan culture in the Rwandan language. Therefore, this study aims to first culturally adapt and test a psychometrically reliable and valid scale for measuring Ubuntu. This study investigates the effects of CBHS on Ubuntu, mental health and psychosocial outcomes, including mental wellbeing, social capital, resilience, intimate partner violence and psychosomatic symptoms in post-genocide Rwanda.

Study objectives

To adapt, translate, and psychometrically test the reliability and validity of an existing Ubuntu scale in the Rwandan context.

To evaluate the effects of the Community-based Social Healing model on Ubuntu in Rwandan participants.

To evaluate the effects of the Community-based Social Healing model on mental health, including measures of depression, anxiety, post-traumatic stress, wellbeing, resilience, and psychosomatic symptoms in Rwandan participants.

To evaluate the effects of the Community-based Social Healing model on psychosocial functioning, including intimate partner violence and social capital in Rwandan participants.

To evaluate the extent to which Ubuntu mediates the effects of the Community-Based Social Healing on mental health, and psychosocial functioning in Rwandan participants.

Study hypotheses

Participation in CBSH is associated with significant improvements in Ubuntu compared to no intervention

Participation in CBSH is associated with significant improvements in mental health, including measures of depression, anxiety, post-traumatic stress, wellbeing, resilience, and psychosomatic symptoms compared to no intervention.

Participation in CBSH is associated with significant improvements in psychosocial functioning, including decreased intimate partner violence and increased social capital compared to no intervention.

The improvement of Ubuntu correlates with improvements in mental health and psychosocial functioning.

Trial design

This is a cluster Randomized Controlled Trial. Participants were recruited from randomly selected villages. Selected village clusters were randomly allocated to either the intervention group (i.e., ones receiving the CBSH intervention), or to the wait-list control group (i.e., waiting for the intervention). The randomization to either the intervention or control group was done using Microsoft Excel. No placebo or other active treatment is offered to the control group. The control group will have access to treatment as usual through their primary healthcare provider. This clinical trial study design and report follows the standard Protocol Items: recommendations for Interventional Trials (SPIRIT) 2013 statement (26).

Study setting

This trial is being conducted from December 2023 to January 2025 in 54 randomly selected villages in the Kirehe district, Eastern Province, Rwanda. Kirehe district has high rates of mental health conditions (22.1%) and suicidality (27,28). Moreover, there are no Non-Governmental Organizations, community-based social healing, or mental health organizations working in that region.

Selection of eligible study villages

For this study, 54 villages will be selected randomly from the Ubuntu Center for Peace list of all 612 villages in Kirehe district using Microsoft Excel software, obtained from the Ubuntu Centre for Peace organization. The list of villages obtained is in an excel document with 4 columns: A (District), B (Sector), C (cell), and D (Village). Sectors, cells, and villages are in alphabetic order. We will create a column of randomized values for each village, Column E, using the command = Rand ( ). Then, we copy and paste Values in the next column, F, to have fixed random values. Column E of random values was deleted and replaced by the fixed random values. Next, the values were ranked from highest to lowest. Finally, the 54 highest ranked villages were selected to be part of the study. To ensure that there would not be spillover and/or crossover effects, the villages were at least 1km apart from each other. For that, the Ubuntu Centre for Peace evaluated whether the villages were too close. If some selected villages were too close to one another, the lowest ranked among them was removed and the next highest-ranked village on the list was selected.

Community Healing Assistants (CHAs)' selection and participants’ recruitment

The trial participants were recruited by Community Healing Assistants (CHAs), who are community members. CHAs were selected from the 54 villages that are part of the study. They were always selected in pairs, meaning that 27 CHA pairs were selected out of 27 villages that are randomly selected out of the 54 villages.

Participants were recruited through trained Community Healing Assistants (CHAs). CHAs know most of troubled people in their community. In addition, they asked the village leaders to recommend people in the village who are troubled and who could benefit from the CBSH program. They targeted mainly genocide survivors, ex-prisoners genocide perpetrators, couples experiencing family conflicts or violence, single mothers, people in extreme poverty. They then visited them at their home, explained everything about the program one-on-one and invited them to join it. CHAs selected 20 participants per village, following the intervention selection criteria. One pair of CHAs recruited participants from their own village and from one additional village. Participants from all 54 villages were selected, making a total of 1080 participants.

Participants’ eligibility criteria

Inclusion criteria:

18 years and older
Recruited by the CHAs
Residing in Kirehe district during the study period

Exclusion criteria:

Candidates who are unable to communicate, with hearing and speech disability with no translator.
Candidates who are mentally and intellectually incapacitated and are unable to understand and respond to the questions.
People who have already participated in CBSH intervention or similar programs.

Ethical considerations:

This trial has been ethically approved by the Institutional Review Board of the College of Medicine and Health Sciences at the University of Rwanda. The trial has been registered with ISRCTN (ID: ISRCTN1765936, registered on February 09, 2024). Trained data collectors, all clinical psychologists, will be provided with detailed explanations regarding the study, the objectives, and instructions for obtaining informed consent prior to participation. The participant candidates will be informed that their participation in the study is voluntary and that they have the right to withdraw anytime with no repercussions. Participants assigned to the wait-list control group will participate in the intervention after the final round of data collection. Each study participant is assigned an identification code. The identification code will be used on all test measure documents. The names of the participants will not appear on test measures or on data sheets. A Master List of the participants’ names and their associated codes will only be accessed by the PI. To protect participants’ confidentiality, all collected data will be anonymized and be stored along with other documents related to the study, in a password-protected computer only accessible to the research team.

2.4. Randomization

Villages allocation to intervention and control

The random assignment of the villages to either intervention or control group was done at the level of the villages after all participants have been selected, using Microsoft Excel. Each pair of CHAs have selected participants in two villages, i.e., their own village and the paired village. Randomization into intervention and control groups was done for each pair of villages allocated to a pair of CHAs.

Using Microsoft Excel, all 54 villages were listed per pair of CHAs making it 3 columns: A (2 CHAs), B (CHAs own village), C (CHAs’ second village). Random values were created in the next Column D using command = Rand(). The values were copied and pasted fixed values in Column F. Then, the fixed values were copied in the Column G and modified by subtracting 0.5. If the resulting number was positive, indicating that it's above 0.5, the CHA's own village was selected for intervention while the other village becomes the control. Conversely, if the resulting number was negative, indicating it's below 0.5, the second village was designated for intervention, with the other village serving as the control. Consequently, CHAs have equal chances of serving their own village or another village for whom they selected the participants. This procedure was repeated until 27 villages were allocated to either case or control; the remaining villages were then allocated to whichever group (i.e., case or control) that was not yet completed. This process was conducted by external Researchers from the University of Rwanda.

The intervention

Explanation of the comparators

The trial participants in the intervention group receive CBSH, while those in the control group are on a waiting list. This is done to assess the impact of CBSH on Ubuntu and the secondary outcomes in comparison to a wait-list control. In adherence to ethical standards, participants assigned to the waiting list (control groups) will also participate in the CBSH after the final evaluation of the trial. While waiting to participate in the CBSH, the control group will have access to their usual care through their existing primary healthcare services (care as usual).

Intervention description

The Community-Based Social Healing (CBSH) model is a scalable, culturally sensitive, non- stigmatizing, accessible and cost-effective community mental health approach. This model is being implemented by the Ubuntu Center for Peace, a Non-profit Organization that strives to bring people living with the consequences of trauma experiences, including common mental health conditions to a more flourishing life.

The CBSH model includes a manualized program of BREATH-BODY-MIND™ (BBM) practices, allowing people to share individual narratives in a safe group setting, and engage in local social rituals. These sessions are provided by Community Healing Assistants (CHAs) who are members of the same community as the participants (i.e., village), and who are recruited by the Ubuntu Center for Peace. The CHAs receive a 6-week training that covers Breath-Body-Mind techniques, the theory of emotional anatomy that describes childhood traumatic experiences associated with sacrificing one’s authenticity and adapting to situations to keep connections to the caretaker and how these traumas and adaptations affect individuals as they grow. They learn about trauma and Post-Traumatic Stress Disorders (PTSD), depression, anxiety disorders and their causes; Sexual and Gender-based Violence (SGBV), non-violent communication, five love languages, JOHARI windows, Tree of Life, evolving from trauma to wholeness, social entrepreneurship and how to recruit participants affected by trauma and common mental conditions. Additionally, they learn how to collect data and are equipped with smart phones as well as with group facilitation skills. CHAs then facilitate healing practices through therapeutic groups. The CHAs are supervised and mentored by professional psychologists.

Each therapeutic group is comprised of 18–20 people who meet once a week for 2–3 hours, over a period of 15 weeks. They then transition to long-term support or self-help groups and create additional socio-economic activities including lending circles, solidarity work, and business or farming cooperatives to sustain healing, health, and resilience.

Setting, Principles and Processes of the Healing Practices

Participants sit in the circle at a participant’s home or local church, office or school and set up principles that they all abide by including confidentiality, equal participation, democracy, mutual respect and dignity. The setting and principles create a feeling of belonging and connection and a sense of equality. They allow a smooth process in the healing journey as described below.

The session begins with local rituals, dancing and/or singing followed by group sharing (checking in). Participants talk about what they experienced during the week. The theme for the day is introduced. Next, the group does a Breath-Body-Mind sequence for 40 minutes followed by a structured group sharing process related to the theme of the day. The session ends with coherent breathing.

Breath-Body-Mind sequence

Activating practices:

Body Tapping or Shaking with or without music. No more than 5 minutes.

Two forms of Ha breath – arm movements while making a loud “Ha” sound for one or two rounds of 10 breaths performed at 20 breaths per minute (bpm).

Balancing and Calming Practices using arm movements synchronized with breathing:

4-4-6-2 Breath (inhale 4 counts, hold breath 4 counts, exhale 6 counts, hold 2 counts) with synchronized Qigong arm movements.

Balancing and Calming Practices using arm movements synchronized with coherent breathing at 5 bpm

Either 4–4 Breath (inhale 4 counts, exhale 4 counts) with Arm Circles or

Painting the Waterfall with arm movements and visualization.

Weeks 6 or 7 introduce Sky and Earth Qigong movements synchronized with coherent breathing (5 bpm).

Open Joints (Joint Mobility Exercises) Sessions#1, #6, and optionally as needed.

Group Sharing Process

Coherent Breathing is performed after the Group Sharing Processes:

starts with two deep relaxing breaths: slow inhale and long exhale with deep sighing sound

top-down muscle relaxation

coherent (or resonant) breathing is gentle, natural breathing at 5 bpm, in and out through the nose with equal duration of the inspiratory and expiratory phases. This technique is practiced at the end of the healing session, before participants go home. The length of coherent breath practice starts with 7–8 minutes and increases gradually up to 20 min.

ends with bottom-up Body Scan.

Group Sharing Processes

Week 1–4

Creation of a safe space for the therapeutic groups. CHAs help the healing or therapeutic groups create group safety contracts, for example, all participants agree to maintain the confidentiality of the other participants. They employ methodologies and relevant exercises that help participants become more aware of their fears and identify situations that prevent them from feeling safe and emotionally vulnerable. This phase helps participants create bonds between them in their healing journey.

Week 5–7

Enhancing trust and emotional vulnerability amongst participants through specialized exercises and practices, becoming more aware of and progressively sharing their deep emotional traumas that led to guilt, shame, resentment, fear, denial, and doubt.

Week 8: Introduction of the Tree of Life as a tool to help structure storytelling/ personal narratives and to provide a metaphor for healing. Different parts of the tree symbolize key aspects of our lives: roots symbolize our historical background; the trunk symbolizes our current lives; branches symbolize our families and friends, leaves symbolize how we nourish ourselves – physically, emotionally, mentally, and spiritually; ripe fruits symbolize our accomplishments; green fruits symbolize our hopes and dreams; and thorns symbolize our challenges and barriers to healing and self-actualization.

Week 9–13

Participants tell and retell their stories in smaller groups of 4–6 people each, using the symbolism of the Tree of Life. As they share their personal narratives, they reinterpret the meaning of their traumatic events, feel seen, heard, and acknowledged, listen to one another with empathy, learn from one another, humanize one another, and feel part of a secondary family with a new vision.

Week 14–15

Group participants focus on the future, discussing the transition to a self-help group. They start exploring socio-economic activities that they want to integrate in their healing journey, such as cooperatives, solidarity work, lending circles, and more, to sustain healing, health and resilience. They are empowered with basic leadership skills to manage their self-help groups effectively.

Graduation ceremony and transition to self-help groups

At the completion of 15 weeks, participants celebrate together, but family members who were not part of the healing program are not invited. They invite government authorities and other dignitaries. During the graduation celebration, they practice BBM and share testimonials. With a candle ceremony, participants make commitments for what they will do through the long-term support group.

Supportive supervision and mentorship

At least once a month, a psychologist supervises the CHAs while they are facilitating healing sessions in their groups. In addition, psychologists provide a one-day refresher training with feedback from all CHAs, every 4 weeks.

Criteria for discontinuing or modifying allocated interventions

The CBSH has been implemented in different regions in Rwanda and both qualitative and quantitative data was collected with good evidence that this intervention causes no harm. Participants in the intervention can always end their participation at their own free choice. A participant can be removed from a therapeutic group by the group leaders, if he or she does not adhere to the rules and regulations of the group, including breaching confidentiality. For the trial, the participation of those assigned to the intervention will only be discontinued if the participant requests to withdraw from the study (as our main analysis is based on the Intention-to-Treat principle).

Strategies to improve adherence to intervention.

During the weeks of intervention, participants are encouraged to adhere to the group sessions by the CHAs. There is a protocol implemented by CHAs with the support of psychologists who supervise them. If a participant does not show up for one session, the CHA contacts the person to find out why they did not come and encourages them to come to the next session. They note the reason underlying the participant’s absence and share this information with the supervisor. If the person does not show up for more than one session, the CHA visits them and finds out why they didn’t come. The CHA responds based on guidance by the supervisor. CHAs’ supervisors call them weekly and visit them monthly to ensure quality monitoring and retention strategy. A participant is considered to have fully participated in a CBSH group if he/she attended at a minimum NUMBER of sessions. Active participants continue to participate in the healing group practices and complete the 15 weeklong program.

Relevant concomitant care permitted or prohibited during the trial

There are no planned concomitant interventions that will take place in the area where the CBSH intervention will be conducted. The participants will be free to participate in any other intervention program that may arise during the trial period without requiring permission from the CHAs. To ensure control over co-intervention bias, we will monitor whether the participants are involved in similar group therapy programs (29).

Provisions for post-trial care

This study poses no risk to the participants, except the risk of potential discomfort due to discussing participants’ personal matters. In addition, clinical psychologists are available to provide psychological support in case of any crises during the intervention. The participants will not receive any monetary compensation. Participants in the control group will be waitlisted and will have the opportunity to participate in the CBSH intervention after the final evaluation. Participants in the intervention groups will continue receiving support through the long-term CBSH group activities. They will also have access to their usual local primary care providers.

Outcome Measures

Socio-demographic characteristics will be obtained using the sociodemographic questionnaire.

Primary outcome measures

The Ubuntu measurement scale developed by Itayi Mutsonziwa’s (PhD thesis) has 3 indicators: humanness, interconnectedness, and compassion with 6, 5, and 8 items respectively (30). The 9-item Ubuntu scale by Terblanché-Greeff and Nel will also be used for convergent validity testing (31).

The effects of the CBSH Model on Mental health will be assessed using:

The Patient Health Questionnaire (PHQ-9) for depression (32).

The Generalized Anxiety Disorder assessment (GAD-7) for anxiety (33).

The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) for posttraumatic stress disorder (34).

Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing scale (WEMWS) (35).

Resilience will be assessed using the 10-item Connor-Davidson Resilience scale (CD-RISK-10) (36).

Psychosomatic symptoms will be assessed using the Patient Health Questionnaire 15-item Somatic Symptom Severity Scale (PHQ-15) (37).

Secondary outcome measures

The effects of the CBSH Model on psychosocial functioning will be evaluated using the following:

Intimate partner violence will be assessed using the Revised Conflict Tactics scale short form (CTS2S SHORT FORM) (38).

Social capital will be measured using the Adapted Social Capital Assessment Tool (SASCAT) (39)

Participant timeline

The schematic chart and study schedule are shown in Figs. 1 and table 1.

Figure 1. shows when the test measures will be obtained from both groups. The baseline data is collected at T1 after villages are randomly selected and participants recruited, but before they are randomly allocated to either intervention or control group. The endline data is collected at T2, immediately after the intervention and at T3, the follow up data collection is collected six months after the intervention.

Table 1

The Community-based social healing (CBSH) trial work plan
	Study period
Time point	Enrollment		Allocation	Post-allocation
ENROLLMENT:	Dec-2023	Jan-24	Feb-24	Mar-24	Apr-24	May-24	June-24	Jul-24	Jan-25
Screening	Dec 13 – Jan 26
Informed consent		Jan 29 – Feb 7
Allocation			Feb 7
INTERVENTIONS:
CBSH				March 1 – June 23
ASSESSMENTS:
Baseline tests		Jan 29 – Feb 7
15-week tests							June 24-July 10
Final tests									6–17

Table 1. shows the protocol schedule starting with the participants’ enrollment in the Community-based Social Healing (CBSH) intervention and ending with the final assessments.

Sample size

The objective of the sample calculation for this research proposal is to determine the required total sample size and cluster size considering the cluster randomized controlled trial (cRCT) design. The research aims to investigate the effect of the intervention, considering an intra-cluster correlation coefficient (ICC) of 0.13, which was based on previous pilot study data. Each cluster was designed to contain 20 individuals, and an effect size of 0.2 was considered. This effect size was chosen to ensure the study's sensitivity in detecting even small effects if they exist, reflecting the research team's commitment to robustly evaluate the intervention's impact. An expectation of two individuals to be lost to follow-up in each cluster was included in the calculation, based on previous experiences with the implementation of the intervention. Using standard statistical formulas, the study determined that a total sample size of approximately 1,080 individuals will be necessary to achieve the desired statistical power of 0.80 and a significance level of alpha = 0.05 while accounting for attrition. To evenly distribute participants between the control and intervention groups, an allocation of 27 clusters to each group is proposed, ensuring a balanced study design. This calculation highlighted the importance of incorporating real-world experiences and statistical rigor into the design of this study, especially in the context of cluster randomized trials.

Assignment of interventions: randomized allocation

Sequence generation

All computer-generated randomization sequence numbers were generated using Microsoft excel. The random selection of 54 villages in Kirehe is detailed in the “Selection of eligible study villages” section. The allocation of villages to intervention or control groups is detailed in the “Randomization” section.

Concealment mechanism

The allocation of villages to intervention and control will be performed after the baseline data collection. The allocations were concealed from the CHAs until the beginning of the intervention to avoid biased selection of participants and from the participants to avoid the influence of knowledge of the group they would belong to (39).

Assignment of interventions: blinding

It is not possible to blind the subjects or CHA facilitators to the intervention in mind-body studies, as we do not organize a placebo activity for the control group. However, data will be anonymized (i.e. all identifying information will be removed and a participant number will be used instead of the names. Consequently, data collectors will be blind to the group assignment.

Data collection and management

Plans for assessment and collection of outcomes

The Ubuntu measurement scales were validated through translation and back-translation and content reviewed by subject matter experts and beneficiaries. Through two Focus Group Discussions, they determined that the scales were appropriate culturally for Rwanda and didn’t make any changes. Trial data will be collected using a team of 16 data collectors who were trained for two days about study objectives, ethical considerations, data quality and the questionnaires. They use standardized questionnaires on mental health, social capital, resilience, intimate partner violence and somatic symptoms. Prior to the actual data collection, questionnaires will be tested by data collectors for clarity and data accuracy. Data collections will take about 1 hour per participant.

Plans to promote participant retention and complete follow-up

There is a participant retention protocol that will be implemented by CHAs with the support of psychologists who supervise them. These plans and protocol are detailed in the section “Strategies to improve adherence to intervention”.

Data management

Detailed notes will be taken during qualitative preparatory data collection and will be accessible to the research team. Quantitative data will be collected in Kobo toolbox, an electronic data management system, and will be extracted for statistical analysis. The data will be managed by a researcher who will check the quality of the data during and after data collection as well as clean it. All files related to the research such as attendance list, ID logs and informed consent forms will be kept in a secure place throughout the research. All data and information will be stored in a password-protected computer, only accessible to the research team.

Confidentiality

All qualitative and quantitative data, and other documents related to the study will be anonymized and stored in a password-protected computer only accessible to the research team. In addition, confidentiality is a vital component of the principles of the intervention. In the first therapeutic group session, participants commit themselves to respecting and preserving one another’s confidentiality for their safety.

Data collection

Both qualitative and quantitative data will be collected. First, qualitative data was collected for content validation of the Ubuntu measurement scales. The tools were translated into Kinyarwanda and back translated. A team of three people (two translators and one back-translator) met to review the questionnaire and come to a consensus, which culminated in the final Ubuntu scales in the Kinyarwanda language. The translated tools were then used at preparatory workshops. One workshop was attended by the Community-Based Social Healing (CBSH) Subject Matter Experts (SMEs) including academics and senior staff of the Ubuntu Center for Peace; the other workshop was with beneficiaries. Content validity was tested in terms of understandability, relevance, and comprehensiveness of the proposed measurement tools for examining the relevance of indicators and item-by-item evaluation. This was done to ensure effective contextualization of the Ubuntu measurement tools in Rwanda.

For the quantitative data, a team of 16 data collectors will be recruited and trained for two days on the ethics for human research, research objectives, questionnaire content, and electronic data capture. This was followed by practical sessions to ensure accurate, reliable, consistent collection of data. Quantitative data will be collected and analyzed using an electronic data management system (Kobo toolbox). After training, a one-day questionnaire testing will be done, in which each data collector interviews two participants. This ensures that data collectors are comfortable with the questionnaires and that the questions are understandable to the participants. It also allows us to correct any mistakes in the questionnaire design and/or set up in the electronic data management system. The interviews will last approximately one hour. Data collection is done prior to the first group sessions, followed by one endline and one follow up round of data collection, immediately after the intervention (endline) and 6 months after the intervention (follow up).

5.7. Statistical methods

Psychometric testing

Confirmatory Factor Analysis (CFA) will be performed on the Ubuntu measurement tool to examine factorial validity on the entire baseline sample. The CFA model will be evaluated by examining the model fit indices (i.e., non-significant chi-square, values close to .95 or greater for GFI, CFI, and TLI, and values close to or less than 0.8 for RMSEA), the magnitude of the factor loadings, and correlations among the latent variables. Further, discriminant and convergent validity will be calculated. Cronbach’s alpha (a) and mean inter-item correlation (MIIC) will be used to evaluate the tools’ internal consistency. Items will be removed for final analysis if they have poor psychometric characteristics. Specifically, items with factor loadings below 0.4, low item-total correlations (less than 0.3), or high cross-loadings will be considered for removal. Additionally, items that negatively impact the Cronbach’s alpha or have mean inter-item correlations outside the acceptable range (0.15 to 0.50) will also be candidates for removal.

Primary analysis

Pearson correlation analyses will be conducted to examine the strength of associations between all facets of Ubuntu variables and mental health, mental wellbeing, and other secondary outcomes to deal with multicollinearity concerns. We will employ a linear mixed-effects model to assess the treatment effect, incorporating both fixed effects related to the intervention and random effects representing village-specific variations, participants’ age, gender/sex, and location. Age will be considered as a continuous fixed effect, so it will be z-scored in the models. By considering the interdependence within villages, this approach allows us to accurately evaluate the intervention's influence on the primary outcome (Ubuntu) and secondary outcomes (mental health and mental wellbeing, social capital, resilience, intimate partner violence and psychosomatic symptoms). The main effects and interaction effects will be examined for age, gender, and location. The Akaike Information Criterion (AIC) will be used to compare and select the models with the lowest AIC score. Furthermore, different types of models (simple mediation, multiple parallel mediation models, and Structural Equation Models (SEM) using the MPlus software) will be used to examine different hypothesized mediating effects of Ubuntu. Finally, as we regard this study as discovery research, we will also analyze in an exploratory fashion whether the model fit of SEM models are better when we turn around the mediation relationship and consider Ubuntu as the main outcome and mental health, mental wellbeing, social capital, resilience, intimate partner violence and psychosomatic symptoms as mediating variables.

Interim analyses

There will be no interim analysis of primary and secondary outcomes. Data will be monitored to ensure the right format for baseline, endline and follow up data collections.

Qualitative data analysis

The detailed notes from the workshops will be analyzed in Kinyarwanda. The emerging language corrections will be applied and important missing items that represent the Rwandan Ubuntu context will be added.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data

In case of missing data, the detailed reasons will be reported. If the missing data is less than 5%, the strategy for handling it will involve employing multiple imputation techniques. This will be done using SPSS version 28.

Plans to for accessing the full protocol, anonymized participant-level data and statistical code

The public will access the full protocol upon publication. There are no other plans to access the full protocol, participant dataset and statistical codes.

Adverse event reporting and harms

Participation in this study causes no known harm or adverse event. However, responding to questions related to personal life, might cause a participant to feel uncomfortable or to experience some emotional distress. Data collectors will record adverse events that might occur and report them to the researchers in the field, using an adapted standardized stress protocol that has been used in similar studies by the research team. Psychological support and referrals can be provided by a clinical psychologist as part of the protocol.

Plans for communicating important protocol amendments to relevant parties

All amendments made to the protocol will be reported to the Institutional Review Board of the College of Medicine and Health Sciences for review and approval. The approved amendments will be signed and dated by the Principal Investigator before implementation. Deviations from the protocol will be documented in the participant file.

Dissemination Plans

The results of this study will be submitted for publication in peer-reviewed journals and disseminated at local, community and policy levels. Detailed feedback will be given to the Ubuntu Centre for Peace. Upon reasonable request, the principal investigator will provide the participant-level anonymized dataset and statistical codes.

Trial status

This is the original version of the protocol, issued in February 2024. The recruitment phase started in December 2023 and ended by January 2024. Any changes or protocol amendments will be accounted for in the public study record available on clinical trials. gov with ID: sISRCTN17659369.

This study is the first to examine the effect of CBSH model on Ubuntu among its participants, including those who have experienced psychological traumas such as genocide, mass killings, sexual abuse and domestic abuse. The previous CBSH program, a pilot study of 1899 Rwandans showed significant improvements in depression, anxiety, and PTSD (19). Moreover, this model demonstrated substantial improvements in family relationships and work productivity (19). The improvements associated with participation in the CBSH align with the Ubuntu way of living. Ubuntu fosters individual wellbeing in a collective environment, thereby creating a support system for the person and their society. This study will permit us to explore Ubuntu in the Rwandan context and psychometrically validate the adapted measurement tools. Our hypothesis is that, compared to the control group, the intervention group receiving the CBSH will have significantly greater improvements in Ubuntu, mental health, and psychosocial functioning. The results of this study could be valuable for the Ubuntu Centre for Peace in implementing the CBSH and to policymakers, healthcare practitioners, and other stakeholders. This study could strengthen the evidence base that supports the importance of fostering Ubuntu by integrating breath-centered mind-body methods, and communal group processes to address and heal psychosocial consequences of trauma. The quantitative and qualitative data generated by this work will provide a rich source of information to guide the adaptation of this CBSH model to the diverse people of Africa and other continents where interventions are sorely needed to cope with and recover more effectively from numerous natural and man-made disasters.

Acknowledgements

Not applicable

Authors’ Contributions

SJ, JBN and PLG are the trial’s principal investigators who conceptualized the study and its objectives and designed its methods. JBN designed and provided background on the CBSH methodology; PLG and RPB designed and provided background and methodology of the Breath-Body-Mind intervention. EP determined the sample size and he is the data analyst along with JN. AN and JN drafted the manuscript. JN, EP and SJ developed the data analysis plan. All authors revised and reviewed the manuscript and contributed to the final approval of the manuscript. All authors will fulfil authorship eligibility guidelines according to the International Committee of Medical Journal Editors (ICMJE).

Funding

This study was funded by the Trauma Research Foundation and Ubuntu Centre for Peace.

The Trauma Research Foundation did not play a role in study design; collection, management, analysis, and interpretation of data; writing of the report but has an agreement with the Ubuntu Center for Peace on the submission of the report for publication. Ubuntu Center for Peace contributed to deciding on the objectives of the study and providing background on the CBSH methodology and the decision to submit the report for publication.

Sponsor

N/A

Availability of data and materials

Upon reasonable request from the corresponding author, the final anonymized data set for the proposed study will be provided.

Ethics approval and consent to participate

The Institutional Review Board of the College of Medicine and Health Sciences at the University of Rwanda has granted ethical approval to this trial. The trial has already been registered with ISRCTN (ISRCTN17659369, registered on February 09, 2024). Eligible participants will be given an explanation of the study, including potential risks and benefits, and will sign informed consent forms prior to participating.

Consent for publication