Mindfulness-integrated Cognitive Behavior Therapy reduces pain and psychological distress, and improves equanimity, hope and post-traumatic growth during breast cancer treatment

doi:10.21203/rs.3.rs-4968979/v1

Background Chemotherapy is associated with many side effects, including pain and psychological discomforts, which affect patients' physical and psychological health.

Objectives. The objective of this study was to evaluate the effectiveness of a shortened version of Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) in managing pain and psychological distress (including depression, anxiety, and stress), improving equanimity, hope, and post-traumatic growth in patients with Stage I-III breast cancer undergoing chemotherapy.

Methods A total of 62 women were randomly assigned to either an intervention group (n=21) or a treatment-as-usual (TAU) control group (n=21), with 9 women lost to follow-up. All participants completed a battery of assessments for pain, emotional distress, hope, equanimity, and post-traumatic growth before and after the intervention, as well as at the 2-month follow-up. The intervention consisted of a short (4-week) version of the MiCBT program, which involved progressive muscle relaxation, mindfulness of breath, body scanning, and the mindfulness-based interoceptive exposure task (MIET) for pain.

Results The MiCBT program was conducted over four consecutive weeks with an emphasis on the mindfulness-based interoceptive exposure task (MIET) for pain. Compared with the TAU group, at post-treatment, the MiCBT group experienced larger and significant reductions in pain, psychological distress, depression, anxiety, and stress, and large improvements in equanimity and hope. These differences remained significant at 2-month follow-up.

Conclusion This study provides preliminary evidence that a four-week MiCBT intervention can improve the daily experiences of women with BC undergoing chemotherapy. Further research using larger samples and active control is needed to determine the generalizability of the results.

Trial registration This study was registered in the Iranian Clinical Trial Registry (registry ID: IRCT20220903055860N1, registration date: 2022-09-29).

breast cancer

pain

interoceptive exposure

Mindfulness-integrated Cognitive Behavior Therapy

MiCBT

This study provides the first evidence that a four-week MiCBT intervention can help reduce physical and psychological discomfort and increase positive aspects of daily life in women with breast cancer undergoing chemotherapy. Although we recommend the use of this program as an adjunct to standard breast cancer treatment, further research using a larger sample and active control group is needed to determine the generalizability of the results.

Breast cancer (BC) is the most common cancer worldwide, with approximately 2.3 million new cases each year (Sung et al., 2021). While advances in treatment have led to a 70–80% survival rate for new cases of BC (Wilkinson & Gathani, 2022), the side-effects and long duration of chemotherapy negatively impacts the person’s physical, psychological, and spiritual well-being. Pain affects 25–60% of women with BC (Andersen & Kehlet, 2011), and in survivors, the prevalence is approximately 35% (Jiang et al., 2019). Women with BC also experience high rates of depression, anxiety, and stress, with prevalence rates ranging from 32–78% (Alagizy et al., 2020).

In recent years, much effort has been made to manage and moderate psychological side-effects associated with cancer treatment through the use of mindfulness-based programs (MBPs) (Ladenbauer & Singer, 2022). The most commonly used MBPs for BC treatment are mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) (Olsson Möller et al., 2019). While studies have demonstrated the efficacy of MBPs in reducing psychological distress in patients with BC (Carlson et al., 2016; Park et al., 2020; Zimmaro et al., 2020), there are only few and their effectiveness for pain management has been controversial (Ball et al., 2017; Zhang et al., 2016). The various levels of discomfort and other side-effects during chemotherapy may render long-term interventions that require daily exercises difficult to implement.

Accordingly, it may be helpful to evaluate the potential benefits of a short-term and practical intervention that is unhindered by the side-effects of chemotherapy. A recent study investigating the transdiagnostic benefits of the Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) program (Francis et al., 2022) found that the benefits to participants with a wide range of psychological disorders peaked at about four weeks into the program and maintained their gains at post-treatment and follow-up. Their results show that equanimity was the principal active mechanism of change. Equanimity is the ability to accept pleasant, unpleasant, and neutral experiences while preventing habitual reactivity (Rogers et al., 2021) and is therefore beneficial in the context of pain management.

Due to our particular interest in the transdiagnostic applicability of MiCBT, this study used a shortened version of MiCBT in an attempt to help reduce chemotherapy side effects, including pain, depression, stress, and anxiety. The short version of MiCBT is a four-week intervention comprising progressive muscle relaxation, mindfulness of breath, body scanning, and the mindfulness-based interoceptive exposure task (MIET).

The MIET, a brief method within MiCBT, addresses distressing emotions and physical pain by encouraging individuals to focus on their present-moment experiences for 30 seconds (B. Cayoun et al., 2020). This approach targets four characteristics of sensations—mass, temperature, motion, and fluidity—aiming to reduce avoidance and emotional reactivity while enhancing self-efficacy in managing distress. Previous studies have highlighted the MIET's effectiveness in reducing pain and psychological discomfort (B. A. Cayoun et al., 2018), though its impact on breast cancer patients remains unexplored.

We first hypothesized that the MiCBT group would report significant reductions in pain and psychological distress, and increased equanimity, hope and PTG at post-treatment, and these effects would be maintained at two-month follow-up. We also hypothesized that these improvements would be greater in the MiCBT group than in the treatment-as-usual (TAU) control group.

Participants

Forty-nine women with BC aged between 19 and 70 years (M = 46.2; SD = 15.81) were recruited from Shiraz University Hospital, a tertiary medical facility located in central Shiraz, Iran, between September and December 2022. Ethical approval to conduct the study was obtained (Ref. IRCT20220903055860N1). Oncologists and other medical staff referred the participants, and all underwent screening before being included in the study.

The inclusion criteria were: (1) having a clinical diagnosis of non-metastasis BC stages I-III and receiving chemotherapy, (2) aged between 19 and 70 years, (3) having an expected clinical prognosis of one year or longer, and (4) providing written informed consent. Patients with previous experience with mindfulness interventions or any serious physical impairment or psychiatric symptoms—such as mania, delusions, and psychotic states—that could impede study participation were excluded. These comorbidities were examined separately via open-ended questions during the introductory session.

The study flow is represented in Fig. 1. Out of 96 individuals who had been introduced to the researcher by the treatment staff, registered their interest to participate, and had been pre-assessed in a brief telephone screening, 62 participants were invited for a clinical interview conducted by trained clinicians to assess inclusion criteria (Fig. 1). Of the 62 potential participants, 11 declined to participate because of conflicting schedule (n = 5), relocating (n = 1) and did not attend orientation (n = 7).

As shown in Table 1, most participants had stages I and II breast cancer. All participants were diagnosed less than a year prior to the intervention, and none had received radiotherapy or hormonal therapy (Table 1).

Table 1

*Sociodemographic and clinical characteristics.*
	MiCBT group (n = 21)	Control group (n = 21)
	Number of participants (%)	Number of participants (%)	p
Age mean (SD)	45.81 (14.46)	47.52 (17.27)	.77
Age range 19–40	8	7
41–51	4	4
52–62	6	6
63–70	3	4
Marital Status			.94
Single	6	6
Married	12	11
Divorced	2	2
Widow	1	2
Education			.63
Diploma	9	9
B.A	9	8
M.A	2	4
Ph.D	1	-
Employment Status			.39
Employee	6	3
Part-Time	3	3
Retired	1	5
Stay-at-home mother	9	7
Unemployed	2	3
Cancer Stage			.63
I	10	7
II	8	10
III	3	4
History of surgery			.78
Mastectomy	3	2
Lumpectomy	10	9
None	8	10

The pain and mental health information at pre-treatment are shown in Table 2. No significant between-group differences in pain and mental health were observed prior to treatment.

Table 2

*Pain and mental health information at pre-treatment*
Characteristic	Number of participants (%)		p
	MiCBT group (n = 21)	Control group (n = 21)
Pain location in last 2 weeks			.9
Head and neck	6 (29)	5 (24)
Breast	8 (38)	9 (43)
Stomach and back	5 (24)	6 (29)
Legs	2 (10)	1 (5)
Psychological distress (K-10)			.55
Likely to be well	2 (10)	1 (5)
Mild distress	6 (29)	7 (33)
Moderate distress	9 (43)	8 (38)
Severe distress	4 (19)	5 (24)
Depression			.22
Normal to Mild	16 (76)	19 (90)
Moderate to Severe	5 (24)	2 (10)
Anxiety			.83
Normal to Mild	14 (67)	16 (76)
Moderate to Severe	7 (33)	5 (24)
Stress			.56
Normal to Mild	16 (76)	18 (86)
Moderate to Severe	5 (24)	3 (14)

Sample Size

Power analysis was performed using the G*Power 3.1.9.4 software (Faul et al., 2007). Assuming a repeated-measures ANOVA design with two groups and three measurement time points, and considering a medium effect size of f = 0.25 (Cohen, 1988), an alpha level of 0.05, a desired power of 0.80, and a moderate correlation among repeated measures of 0.50, the power analysis demonstrated that a total sample size of 42 participants (21 per group) was appropriate.

Procedure

Profiles of all BC patients who were under treatment in one of the three hospitals at the time of recruitment were provided to the researcher through the treatment staff. The researcher provided general information about the research program to patients by phone and invited them to attend an introductory session at the Taadol Clinic.

During the introductory session, patients were informed about the goals and procedure of the study and were assessed for eligibility by a brief semi-structured clinical interview. This provided demographic information and details of previous mental health conditions and mindfulness training. Those who met inclusion criteria received an information letter and informed consent form. The patients who provided written informed consent for participation were included in the study. Assessments in both groups were performed before randomization (T1, baseline), at post-treatment (T2, 1 month following baseline), and at follow-up (T3, 3 months following baseline). All assessments at baseline, post-treatment and follow-up in both intervention and control groups were conducted online.

Randomization. Before collecting data, participant identification numbers were randomly assigned in a 1:1 ratio to either an intervention group or a control group using a computer-generated random number sequence. This process was conducted by an independent researcher who was not involved in recruitment or intervention procedures.

Intervention. Participants in the intervention group underwent a four-week MiCBT program, consisting of attending a weekly 90-minute group (See Supplementary File 1 for details of the intervention). The intervention was designed based on the MiCBT protocol, which is a structured 10-session intervention that is usually implemented in four distinct stages (B. A. Cayoun et al., 2018).

In the first session, progressive muscle relaxation was implemented to provide rapid relief from muscle tension and sense of self-efficacy. The second session involved the practice of mindfulness of breath, which requires focusing attention on natural, uncontrolled breathing for 30 minutes. This exercise is associated with an increase in both metacognitive awareness and cognitive flexibility (B. A. Cayoun & Shires, 2020). The third session introduced body scanning. In the fourth session, the MIET was introduced and used outside the meditation periods as a pain management and reduction technique in day-to-day activities. (see Supplementary File 1 for detailed instruction).

During the group session, participants were informed that some of their unpleasant sensory experiences were common side-effects of chemotherapy, and that the exercises they were about to perform were not aimed at eliminating these side-effects. Rather, the purpose of the training was to help manage and moderate their psychological discomfort.

Control group. Participants in the control group were assessed and only received the conventional medical cancer treatment during the study period at Shiraz Hospital, where systematic psychological interventions are not offered. They were asked to inform the research team if they received any psychological interventions during the study. Until follow-up, no one in the control group reported receiving a psychological intervention.

Primary Outcome Measures

Brief Pain Inventory. The Brief Pain Inventory (Cleeland & Ryan, 1991) is a 12-item self-report questionnaire produces an overall score ranging from 0 to 120, with 0 representing no pain and 120 representing the most intense pain imaginable. The psychometric properties were evaluated in adults with cancer, with good internal consistency (Cronbach’s alpha = .88 for overall scale, respectively) (Vakilzadeh & Nakhaee, 2006). In the measures section, the overall scale of the Brief Pain Inventory was used.

Psychological distress. The Kessler Psychological Distress Scale (Kessler-10)(Kessler et al., 2002) is a self-completed measure used to assess psychological distress with respect to negative emotional states, with a sensitivity of 86% (Ilie et al., 2020). It is a well-validated ten-item measure using a 5-point Likert scale that produces an overall score ranging from 0 to 40. It has good internal consistency (Cronbach’s alpha = .88) (Sampasa-Kanyinga et al., 2018).

Depression Anxiety and Stress Scales. The Depression Anxiety and Stress Scales-21 (DASS-21) (Lovibond & Lovibond, 1995) is a self-report questionnaire comprising 21 items and is widely utilized to measure the symptoms severity of depression, anxiety, and stress. Participants are required to score each item on a four-point Likert scale, indicating the degree to which it applies to them over the past week. Higher scores correspond to increased levels of distress. The Cronbach alpha reliability coefficients for DASS-21 were very good (overall = .95; depression = .91, anxiety = .87; and stress = .88) (Lee, 2019).

Secondary Outcome Measures

Hope. The Hope Scale (Snyder et al., 1991) is a 12-item self-report questionnaire designed to measure dispositional hope. Participants rate each item on a 5-point Likert scale, with higher scores indicating higher levels of hopefulness. The reliability and validity of this scale have been demonstrated (Cheavens et al., 2019). Internal consistency (Cronbach’s alpha = .78), was found to be acceptable in a sample of adult participants with cancer (Berendes et al., 2010).

Equanimity. The Equanimity Scale 16 (ES-16) (Rogers et al., 2021) is a 16-item self-report questionnaire that evaluates experiential acceptance and non-reactivity, on a 5-point Likert scale. The scale has been shown to have good validity and internal consistency (Cronbach’s alpha = .88), and good test-retest reliability (r = .87). The ES-16 has demonstrated a moderate correlation with life satisfaction (r = .34) and a strong correlation (r = .67) with the Distress Tolerance Scale (Rogers et al., 2021).

Post Traumatic Growth. The PTG Inventory-Revised (PTGI-R) (Tedeschi et al., 2017), which is a 21-item self-report inventory that measures an individual's perception of positive changes following a traumatic life experience. The responses are recorded on a 6-point Likert scale (Tedeschi et al., 2017). The reliability for the normative and cancer patient samples was high (r = .90 and r = .95 respectively) (Garland et al., 2007), and has good internal consistency (Cronbach’s alpha = .96) (Aydin & Kabukçuoğlu, 2020).

Statistical Analysis.

The clinical characteristics of the participants were analyzed by t-test and Chi-square test to examine any differences between groups at baseline. Repeated-measure ANOVA was used to explore changes in pain and secondary outcomes across time, between groups, and Group x Time interaction. The study involved a 2 x 3 mixed design. Repeated measures models with two levels of treatment variables (MiCBT and control group) and three time points (T1, T2, and T3) were used to examine the effectiveness of this intervention in pain, psychological distress, equanimity, hope, and PTG. We used False Discovery Rate (FDR) with p value set at .05 to control for multiple comparisons (Benjamini & Hochberg, 1995). Statistical analyses were conducted using SPSS, Version 26.

Participants

The study proceeded with 49 participants who provided written informed consent and were randomized into either the intervention group (n = 24) or the control group (n = 25). Three participants in the intervention group (attrition rate: 12.5%) were excluded due to health complications (n = 2) and attending less than 2 sessions (n = 1), and 4 participants in the control group (attrition rate: 16%) were excluded due to not attending the follow-up session and were considered dropouts. As shown in Table 1, no significant between-group differences were observed in the demographic and clinical characteristics (see Table 1 and Table 2).

Primary Outcomes

The means and standard deviations are in Table 3. There were no significant baseline differences in pain levels or psychological distress between groups and both groups made improvements over time, as shown in Fig. 2 (see Supplementary File 2 for detail). However, the model revealed significant between-group differences F _(1,40) = 15.67, p < .001, η² = .28, within-group differences F _(2,80) = 167.43, p < .001, η² = .94, and interaction effect F _(2,80) = 11.78, p < .001, η² = .22 in pain severity. As shown in Table 4, the model also revealed significant between-group differences, within-group differences and interaction effects in psychological distress, depression, anxiety and stress.

Post-hoc tests, adjusted by the FDR, revealed a significant difference in pain level in the MiCBT group than in the control group at both T2 (M = 12.57, SD = 1.9, d = 2.03) and T3 (M = 6.47, SD = 2.4, d = .83) (p's < .01). Additionally, there was a significant difference in Kessler scores for the MiCBT group at T2 (M = 3.66, SD = .84, d = 1.34), and T3 (M = 4.85, SD = .67, d = 2.24), than in the control group (p's < .001).

Similarly, depression, anxiety and stress scores were significantly lower in the MiCBT group at T2 and T3, than in the control group (p's < .001). Post-hoc analysis of the control group’s data indicated a significant difference in pain, psychological distress, and stress from T1 to T2 (p's < .01) and a significant difference from T1 to T3 in pain, psychological distress, depression, anxiety and stress (p's < .05) (see Supplementary File 2).

Secondary Outcomes

The model revealed significant between-group, within-group and Group × Time interaction in equanimity, hope, and PTG (Table 4). Post-hoc tests, adjusted by the FDR, revealed a significant difference in equanimity and hope level in the MiCBT group than in the control group at both T2 and T3 (p's < .001). While the between-group difference in PTG was not statistically significant at T2 (M = 6.28, SD = 3.4, d = .56, p < .07), there was a significantly greater improvement at T3 in the MiCBT group than in the control group (M = 16.57, SD = 3.31, d = 1.44, p < .001). In addition, post-hoc tests indicated a significantly difference at both T2 and T3 in the control group than T1 in equanimity, hope and PTG (p's < .01) (see Supplementary File 2).

Table 3

*Mean and standard deviation for each dependent variable, time and group.*
Outcomes	Time		MiCBT			Control
		Mean	SD	(95% CI)	Mean	SD	(95% CI)
Pain	Time 1	59.71	6.13	56.57,62.84	60.86	7.96	57.72,63.99
	Time 2	44.9	6.36	42.18,47.62	57.48	5.98	54.75,60.19
	Time 3	35.57	7.22	32.13,39	42.05	8.31	38.61,45.48
Kessler	Time 1	15.95	5	13.69,18.2	16.81	5.22	14.55,19.06
	Time 2	10.09	2.36	8.89,11.29	13.76	3.04	12.55,16.96
	Time 3	6.57	2.39	5.61,7.52	11.43	1.91	10.47,12.38
Depression	Time 1	10.52	2.96	9.3,11.74	10.05	2.57	8.82,11.27
	Time 2	5.71	1.95	4.92,6.5	9.29	1.61	8.49,10.07
	Time 3	4.62	2.06	3.73,5.5	6.48	1.96	5.58,7.36
Anxiety	Time 1	8.24	2.93	6.94,9.52	7.67	2.92	6.37,8.95
	Time 2	5.14	2.93	4.05,6.23	7.95	1.91	6.86,9.04
	Time 3	3.52	1.83	2.89,4.15	6.52	.87	5.89,7.15
Stress	Time 1	14.76	4.85	12.77,16.75	14.19	4.13	12.2,16.17
	Time 2	8.95	3	7.73,10.16	12.86	2.47	11.64,14.07
	Time 3	6.24	3.37	4.85,7.62	10.14	2.9	8.75,11.53
Equanimity	Time 1	34.48	5.75	31.9,37.05	33.33	5.92	30.75,35.9
	Time 2	49.95	3.54	47.17,52.72	35.14	8.16	32.36,37.91
	Time 3	55.95	6.62	53.22,58.68	41.05	5.71	38.31,43.77
Hope	Time 1	29.1	5.6	26.94,31.24	27.9	3.99	25.75,30.05
	Time 2	36.76	3.11	35.38,38.14	33.62	3.15	32.23,35
	Time 3	44.81	7.35	41.77,47.84	39.76	6.39	36.72,42.8
Post- traumatic growth	Time 1	43.05	10.49	38.58,47.51	40.57	9.75	36.1,45.03
	Time 2	50.57	14.69	45.7,55.43	44.29	5.22	39.42,49.14
	Time 3	72.95	12.18	68.21,77.68	56.38	9.05	51.64,61.11

Table 4

*Regression analysis and effect size for Within-Subject Effects, Between-Subject Effects and Time × Group interaction outcomes*
	Within-Subject Effects			Between-Subject Effects			Time × Group interaction
Measure	F	p	η²	F	p	η²	F	p	η²
Pain	167.43	.001	.8	15.67	.001	.28	11.78	.001	.22
Kessler	69.02	.001	.63	14.33	.001	.26	2.27	.014	.11
Depression	78.61	.001	.66	9.62	.004	.19	14.3	.001	.26
Anxiety	25.89	.001	.39	9.79	.003	.19	12.18	.001	.23
Stress	60.91	.001	.6	7.6	.009	.16	10.23	.001	.2
Equanimity	94.41	.001	.7	52.01	.001	.56	27.48	.001	.4
Hope	137.84	.001	.77	4.63	.03	.1	2.69	.087	.06
PTG	120.98	.001	.75	9.32	.004	.18	55.97	.001	.22

The main aim of this study was to explore the effectiveness of a shortened (four-week) version of the 10-session MiCBT program in reducing pain and psychological distress in women with non-metastatic BC undergoing chemotherapy. The second aim of the study was to examine the potential improvement in equanimity, hope and PTG following this short intervention.

Within-subject data supported our first hypothesis, showing a linear decrease in pain scores for the MiCBT group over three months. This adds support to previous findings that interoceptive awareness and acceptance effectively relieve pain and distress (Park et al., 2020; Zimmaro et al., 2020). The interoceptive desensitization produced by the MIET during MiCBT has been shown to be particularly effective in reducing persistent (B. Cayoun et al., 2020) and acute pain (Hanley et al., 2023). While the full MiCBT program addresses avoidance and interpersonal factors, the shortened version (Stage 1 MiCBT) focuses solely on interoceptive exposure and equanimity. This suggests that mere interoceptive exposure with equanimity and its consequent reappraisal of pain-related self-efficacy were sufficient to produce the analgesic effect.

As previously shown (e.g., Cayoun et al., 2020), promoting unconditional experiential acceptance and preventing emotional reactivity to pain sensations during the practice of equanimity also enhanced psycho-emotional variables. In this study, participants in the MiCBT reported fewer symptoms of depression, anxiety and stress compared to the TAU group. In addition to the expected emotion-regulation effects of mindfulness meditation (B. A. Cayoun & Shires, 2020), the MIET likely facilitated the reappraisal of the inaccurate belief that pain is uniquely a side-effect of chemotherapy and cannot be changed through personal skills (B. Cayoun et al., 2020). The participants’ empowering experience of self-produced analgesia may have also enhanced their sense of self-efficacy and increased their ability to manage side-effects of chemotherapy. In turn, this may have had a carry-on effect in increasing hope, physical activity, resilience, and healthy coping strategies, thereby reducing psychological distress (Arefian & Asgari-Mobarakeh, 2024; Gao et al., 2019).

Although no data were collected on potential adverse effects of MiCBT, none of the participants reported any adverse effect or additional discomfort of the meditation or the MIET during the study or at post-treatment. However, the potential occurrence of adverse effects among those who dropped was not examined. It is possible that some participants have dropped out because of the discomfort resulting from the interoceptive exposure procedure used to cultivate equanimity.

The results also supported our second hypothesis, as these improvements were significantly greater in the MiCBT group than in the control group. While both MiCBT and TAU groups exhibited improvements over time, the MiCBT group consistently demonstrated larger effect sizes at all time points. The systematic improvements in the control group may be best attributed to natural recovery, as discussed below.

In the present study, despite careful randomization, the participants in the MiCBT group collectively rated their equanimity level prior to intervention as being slightly higher than that of those in the control group, resulting in a statistically significant difference at baseline, although with a small effect size. Future studies measuring equanimity will need to control for social desirability. Rogers et al.’s (Rogers et al., 2021) found that equanimity in the general population was positively correlated with social desirability. However, in the present study, the very large magnitude of change over time and between the groups suggests that attending the MiCBT program clearly improved patients’ equanimity and its ability to buffer the effects of depression, anxiety, and stress, as previously shown (Rogers et al., 2021).

Hope and PTG also improved over time, suggesting that the intervention not only reduced aversive mood and cognitions, but also increased positive aspects of participants’ lives. PTG is positively associated with mental health, hope, resilience, and improved adaptation to cancer (Liu et al., 2020). Acceptance of the disease, good coping strategies, social support, and helpful cognitive processes are all important factors in facilitating PTG in patients with BC (Zhai et al., 2019). This is consistent with the transdiagnostic functionality of MiCBT, which helps develop non-judgmental acceptance of present experience, including pain, and promotes a sense of agency over adversity across life domains (B. A. Cayoun, 2015).

Table 3 indicates a decrease in pain and psychological discomfort in the control group, likely due to expected recovery with TAU (Battaglini et al., 2021). However, the lack of active control makes any reliable assumption difficult. Including a measure of social desirability could have assisted in detecting this possible bias. Despite improvements, TAU participants' scores remained in the moderate severity range, indicating a continued need for care. Factors such as cancer type, treatment, and chemotherapy drugs influence side effects (Arefian & Asgari Mobarakeh, 2023), and the lack of control for participants' surgical history may have affected outcomes. Additionally, most participants had cancer stages below 3, suggesting they might experience fewer side effects and faster recovery, while those with a history of surgery or higher cancer stages may face prolonged effects (Xie et al., 2020), potentially explaining differences in effect sizes compared to previous studies.

Limitations and Future Directions

While there was sufficient statistical power for this study, the small sample size increased the susceptibility to outliers. Our access to more participants who met inclusion criteria was limited by our location, and future studies will require larger samples to reduce the probability of type II errors and inflated effect sizes. The lack of active control in the present study also reduced the strength of the results and did not allow to control for such extraneous variables as expectancy effects and social desirability. Moreover, the type, dose, and cycle of chemotherapy may also impact symptoms, and there may be effects of internal and external resources on patients’ well-being.

Moreover, comparing the full 10-session MiCBT program with this shortened version will be important given that the full program addresses interpersonal and social dynamics, and train individuals in self-compassion (B. A. Cayoun et al., 2018). The effects of both versions would be ideally evaluated over a longer follow-up period. Also, investigating the reasons for the attrition rate and receiving feedback from participants regarding the acceptability of the intervention would help inform future MiCBT studies. While program completers reported no additional discomfort either during or following treatment, it is not clear whether those who dropped out experienced adverse effects. Future studies will need to ensure that those who may experience adverse effects receive appropriate information and care.

To the best of our knowledge, this is the first study demonstrating the effectiveness of a short version of MiCBT in reducing a wide spectrum of symptoms in women with BC undergoing chemotherapy. Notwithstanding the above limitations, these early results show the promising well-being gains and clinical benefits of using a four-week MiCBT program as an adjunct treatment with BC survivors.

Ethical approval:

This study was performed according to the Declaration of Helsinki. Ethical approval for the study was approved by the Research Ethics Committees of Isfahan University with an approval ID IR.UI.REC.1401.059 and was registered in the Iranian Clinical Trial Registry (registry ID: IRCT20220903055860N1).

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Funding:

No funds, grants, or other support was received.

Conflicts of interest:

The authors declare that they have no conflicts of interest.

Author Contribution

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [Mohsen Arefian] and [Karim Asgari]. The first draft of the manuscript was written by [Mohsen Arefian] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgement

We would like to express our sincere gratitude to Dr. Bruno Cayoun for his invaluable guidance throughout the various stages of this intervention and the preparation of this manuscript.

Data availability statement:

The data of this study are available from the corresponding author upon reasonable request.

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No competing interests reported.

Mindfulness-integrated Cognitive Behavior Therapy reduces pain and psychological distress, and improves equanimity, hope and post-traumatic growth during breast cancer treatment

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Abstract

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Significance statement

Introduction

Method

Participants

Sample Size

Procedure

Primary Outcome Measures

Secondary Outcome Measures

Statistical Analysis.

Results

Participants

Primary Outcomes

Secondary Outcomes

Discussion

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Ethical approval:

Funding:

Author Contribution

Acknowledgement

Data availability statement:

References

Additional Declarations

Supplementary Files

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Version 1