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Cognitively-Based Compassion Training (CBCT®) in Breast Cancer Survivors: A Randomized Clinical Trial Study.

ABSTRACT: CONTEXT:Breast cancer (BC) requires a significant psychological adaptation once treatment is finished. There is growing evidence of how compassion training enhances psychological and physical well-being, however, there are very few studies analyzing the efficacy of compassion-based Interventions on BC survivors. OBJECTIVE:To study the efficacy of the Cognitively-Based Compassion Training (CBCT) protocol in a BC survivor sample on quality of life, psychological well-being, fear of cancer recurrence, self-compassion, and compassion domains and mindfulness facets. Furthermore, enrollment, adherence, and satisfaction with the intervention were also analyzed. METHODS:A randomized clinical trial was designed. Participants (n = 56) were randomly assigned to CBCT (n = 28) or a treatment-as-usual control group (TAU; n = 28). Pre-post intervention and 6-month follow-up measures took place to evaluate health-related quality of life, psychological well-being; psychological stress, coping strategies, and triggering cognitions; self-compassion and compassion; and mindfulness in both intervention and wait-list groups. RESULTS:Accrual of eligible participants was high (77%), and the drop-out rate was 16%. Attendance to CBCT sessions was high and practice off sessions exceeded expectations). CBCT was effective in diminishing stress caused by FCR, fostering self-kindness and common humanity, and increasing overall self-compassion scores, mindful observation, and acting with awareness skillsets. CONCLUSION:CBCT could be considered a promising and potentially useful intervention to diminish stress caused by FCR and enhance self-kindness, common humanity, overall self-compassion, mindful observation, and acting with awareness skillsets. Nevertheless, future randomized trials are needed and a process of deeper cultural adaptation required.

SUBMITTER: Gonzalez-Hernandez E

PROVIDER: S-EPMC6142100 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Cognitively-Based Compassion Training (CBCT<sup>®</sup>) in Breast Cancer Survivors: A Randomized Clinical Trial Study.

Gonzalez-Hernandez Edgar E Romero Rocio R Campos Daniel D Burychka Diana D Diego-Pedro Rebeca R Baños Rosa R Negi Lobsang Tenzin LT Cebolla Ausiàs A

Integrative cancer therapies 20180422 3

<h4>Context</h4>Breast cancer (BC) requires a significant psychological adaptation once treatment is finished. There is growing evidence of how compassion training enhances psychological and physical well-being, however, there are very few studies analyzing the efficacy of compassion-based Interventions on BC survivors.<h4>Objective</h4>To study the efficacy of the Cognitively-Based Compassion Training (CBCT) protocol in a BC survivor sample on quality of life, psychological well-being, fear of ...[more]

PMID: 29681185

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Project description:INTRODUCTION:Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners' health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient's neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of "Cognitively Based Compassion Training (CBCT®)". However, randomised trials are still scarce. Previous programmes did not involve participation of the patient's romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress. METHODS AND ANALYSIS:Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10?week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, ?-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy. ETHICS AND DISSEMINATION:Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry. TRIAL REGISTRATION NUMBER:NCT03080025.

Project description:BackgroundCancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physical, social, and spiritual well-being both during and after primary cancer treatment. The purpose of this in-progress pilot trial is to determine acceptability and preliminary efficacy (as reflected by effect sizes) of CBCT® (Cognitively-Based Compassion Training) compared with a cancer health education (CHE) attention control to improve the primary outcome of depressive symptoms and secondary outcomes of other HRQOL domains (e.g., anxiety, fatigue), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related outcomes in both cancer survivors and informal caregivers.MethodsForty dyads consisting of solid tumor survivors who have completed primary treatments (chemotherapy, radiation, surgery) and their informal caregivers, with at least one dyad member with ≥ mild depressive symptoms or anxiety, will be recruited from Tucson, Arizona, USA. Survivor-caregiver dyads will be randomized together to complete either CBCT or CHE. CBCT is a manualized, 8-week, group meditation-based intervention that starts with attention and mindfulness and builds to contemplative practices aimed at cultivating compassion to the self and others. The goal of CBCT is to challenge unexamined assumptions about feelings and behaviors, with a focus on generating spontaneous self-compassion and increased empathic responsiveness and compassion for others. CHE is an 8-week, manualized group intervention that provides cancer-specific education on various topics (e.g., cancer advocacy, survivorship wellness). Patient-reported HRQOL outcomes will be assessed before, immediately after (week 9), and 1 month after CBCT or CHE (week 13). At the same time points, stress-related biomarkers of inflammation (e.g., plasma interleukin-6) and saliva cortisol relevant for survivor and informal caregiver wellness and healthcare utilization will be measured.DiscussionIf CBCT shows acceptability, a larger trial will be warranted and appropriately powered to formally test the efficacy of this dyadic intervention. Interventions such as CBCT directed toward both survivors and caregivers may eventually fill a gap in supportive oncology care programs to improve HRQOL and healthcare utilization in both dyad members.Trial registrationClinicaltrials.gov, NCT03459781 . Prospectively registered on 9 March 2018.

Project description:ImportanceCaregivers of people with mental illness are at increased risk of developing depression, anxiety, and stress.ObjectiveTo investigate the effect of a compassion cultivation training (CCT) program on decreasing caregiver psychological distress.Design, setting, and participantsThis waitlist-controlled randomized clinical trial was conducted in 2 different community settings in Denmark. Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment. Enrollment occurred between May 2018 and March 2019. A repeated measurement model was used to examine the impact of the intervention. The primary analysis was based on the intention-to-treat principle. Data analysis was conducted from June 4 to July 7, 2020.InterventionsParticipants were randomized 1-to-1 to an 8-week CCT course or waitlist control. Block randomization was used with 40 participants in each block.Main outcomes and measuresThe main outcome was reduction in psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS). Baseline, postintervention, and 3- and 6-month follow-up measurements were collected.ResultsAmong 192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the CCT intervention and 82 participants in the waitlist control group. At baseline, the mean (SD) DASS scores for the intervention vs control groups were 10.89 (8.66) vs 10.80 (8.38) for depression, 6.89 (6.48) vs 6.68 (5.33) for anxiety, and 14.96 (7.90) vs 15.77 (7.40) for stress. The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24 [95% CI, -3.99 to -0.48]; P = .01; stress, -4.20 [95% CI, -6.73 to -1.67]; P = .001), the 3-month follow-up (adjusted mean difference: depression, -3.78 [95% CI, -6.40 to -1.17]; P = .005; anxiety, -2.50 [95% CI, -4.27 to -0.73]; P = .006; stress, -3.76 [95% CI, -6.32 to -1.21]; P = .004), and the 6-month follow-up (adjusted mean difference: depression: -4.24 [95% CI, -6.97 to -1.52]; P = .002; anxiety, -2.12 [95% CI, -3.96 to -0.29]; P = .02; stress: -3.79 [95% CI, -6.44 to -1.13]; P = .005).Conclusions and relevanceThese findings suggest that CCT was superior to the waitlist control in supporting caregivers' mental health. Statistically and clinically significant reductions in psychological distress were found and sustained at the 6-month follow-up. The improvements noted in this randomized clinical trial could serve to encourage implementation of future evidence-based programs for caregivers.Trial registrationClinicalTrials.gov Identifier: NCT03730155.

Dataset Information

Cognitively-Based Compassion Training (CBCT®) in Breast Cancer Survivors: A Randomized Clinical Trial Study.

Publications

Cognitively-Based Compassion Training (CBCT<sup>®</sup>) in Breast Cancer Survivors: A Randomized Clinical Trial Study.

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