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Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples.

ABSTRACT: 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.

SUBMITTER: Aguilar-Raab C

PROVIDER: S-EPMC6173246 | biostudies-other | 2018 Oct

REPOSITORIES: biostudies-other

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Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples.

Aguilar-Raab Corina C Jarczok Marc N MN Warth Marco M Stoffel Martin M Winter Friederike F Tieck Maria M Berg Judith J Negi Lobsang Tenzin LT Harrison Tim T Pace Thaddeus W W TWW Ditzen Beate B

BMJ open 20181004 9

<h4>Introduction</h4>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 acco ...[more]

PMID: 30287601

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Project description:Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans.Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C.Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes.The ClinicalTrials.gov registration number is NCT00321789.

Project description:Background: Abnormalities in the appearance of skin are commonly associated with compromised self-body perceptions, arising from physical manifestations of the skin condition that deviate from the individual's idealised body image. These body image concerns are associated with a range of psychological issues including anxiety, depression, fear of negative evaluation, and suicidal ideation. Unfortunately, stigma and embarrassment associated with these body image concerns mean that these issues are rarely discussed in clinical medical consultations. There is thus a need for highly accessible and acceptable interventions to address skin-related body image concerns. We have previously demonstrated that a web-based self-compassion focused therapeutic writing approach, the 'My Changed Body' intervention, is efficacious in addressing body image concerns of women in the breast cancer context. The aim of this experimental pilot study was to investigate the feasibility of applying the My Changed Body intervention to address visible skin-related body image concerns. Methods: Participants (N = 50) with a range of visible skin conditions provided online informed consent, then completed measures of demographic and medical history, body image disturbance, self-compassion and positive and negative affect. They were then randomly allocated either to an active control expressive writing condition (n = 25) or to the My Changed Body writing condition (n = 25). Participants were blind to their condition allocation. Immediately after completing their allocated writing exercise, participants completed self-compassion and affect measures. Results: Controlling for pre-writing body image disturbance, repeated measures ANCOVAs with fixed effects revealed that self-compassion and negative affect significantly improved after the My Changed Body writing exercise, compared to the control condition. There was no between groups difference at follow-up in positive affect. Conclusions: This study suggests that the My Changed Body writing intervention may provide benefit to individuals with visible skin conditions. A randomised controlled trial is needed to further confirm these results.

Project description:IntroductionCompassionate patient care has been associated with improved clinical outcomes for patients. However, current evidence suggests that healthcare is experiencing a compassion crisis, with physicians frequently overlooking opportunities to treat patients with compassion. Although there is evidence that compassionate care can be enhanced through training interventions, it is currently unclear what specific skills and behaviours ought to be taught and how best to transfer this information to the learner. The objectives of this systematic review are to collate the world's literature on compassion training to determine (1) the specific skills and behaviours that should be taught (curriculum), and (2) the methods of training that are most effective at improving compassionate patient care.Methods and analysisWe will perform a qualitative systematic review of studies aimed at improving compassionate patient care among physicians and physicians in training. We will comprehensively search CENTRAL, MEDLINE, EMBASE and CINAHL. Additional recommended techniques for systematic reviews of complex evidence will be performed including pursuing selected 'references of references', electronic citation tracking and consulting experts in the field. Two investigators will independently review all search results. After identification and inclusion of papers, we will use a standardised form for data extraction. We will use tables to describe the study populations, interventions tested (including specific skill/behaviours taught and training methods used), outcome measures and effects of interventions on outcome measures compared with control groups. Where appropriate, meta-analysis will be used for quantitative analysis of the data.Ethics and disseminationThe proposed systematic review does not require ethical approval since no individual patient-level data will be collected. Results of this study will contribute to the understanding of compassion training and help inform the development of compassion training curricula.Prospero registration numberCRD42018095040.

Project description:IntroductionMajor depression (MD) often has its onset during adolescence and is associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation and the underlying neural processes. Cognitive reappraisal (CR) is a particular adaptive emotion regulation strategy. Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. Specifically, we will investigate whether the CR training improves the ability to downregulate negative affect in MD individuals as assessed by behavioural and neurobiological indices, and whether training effects generalise outside the laboratory.Methods and analysisAdolescents with MD will be randomly allocated to a group that either receives a task-based training in CR or a control training. Both involve four training sessions over a time period of 2 weeks. In the CR training, participants will be instructed to downregulate negative affective responses to negative pictures via CR, while the control training involves picture viewing. During the training sessions, the Late Positive Potential, gaze fixations on negative picture aspects and affective responses to pictures will be collected. Before and after the training programmes, and at a 2-week follow-up, overall negative and positive affect, rumination and perceived stress will be assessed as primary outcomes. Analyses of variance will be conducted to test the effectiveness of the CR training with regard to both primary outcomes and task-based behavioural and neurobiological parameters.Ethics and disseminationThe study was approved by the Ethics Committee of the Medical Faculty of the LMU Munich, Germany. The results will be published in peer-reviewed journals and disseminated through conferences, social media and public events.Trial registration detailsClinicalTrials.gov NCT03957850, registered 21st May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850.

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.

Dataset Information

Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples.

Publications

Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples.

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