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

IntroductionPositive 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 analysisCouples 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, α-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 disseminationEthical 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.

Mindfulness‐Based Couple Interventions: A Systematic Literature Review

“…Besides mindfulness, other contemplative practices such as compassion have been recently designed as contemporary forms of secular trainings with a specific relational focus (Aguilar‐Raab et al, 2018; CCSCBE, 2019; Collins et al, 2018). Compared with mindfulness, compassion directly emphasizes social interconnectedness and has been shown to further prosocial attitudes and behavior (Gilbert, 2014; Leiberg et al, 2011; Quaglia et al, 2020).…”

Instructed Partnership Appreciation in Depression: Effects on Mood, Momentary Relationship Satisfaction, and Psychobiological Arousal

“…Sample size calculations for the SIDE studies were tailored for the conduction of the subsequent RCT that would further include the DCs who participated in the present study. Analyses with G*Power ( 97 ) were described in the study protocol and revealed an optimal total sample size of N = 50 DCs, accounting for assumed attrition ( 73 ). In the present study, we aimed at recruiting an equal amount of N = 50 additional NDCs for the comparison of PAT responses.…”

“…The SIDE studies contained a cross-sectional, first part in which self-report, psychobiological, and eye-tracking data was collected from DCs and NDCs, and an interventional, second part where participating DCs were randomized to either a 10-week Cognitively Based Compassion Training (CBCT ® ) for couples or to a control treatment. Procedures and methods of this randomized controlled trial (RCT) can be found in the published study protocol (73). No protocol was pre-registered for the cross-sectional part, which is reported here, but many of the present methods (e.g.…”

“…For the purpose of sample characteristics description and statistical control of unintended variability in the outcome data, several psychometric scales were assessed once at either lab day 1 or 2. A complete list of all scales collected in the SIDE studies can be found in the RCT's protocol (73). The following scales were used in the present study: The Patient Health Questionnaire (PHQ-9), the Partnership Questionnaire (PFB), the Berlin Social Support Scale (BSSS), and the Trier Inventory for Chronic Stress (TICS).…”

“…We became aware of this imbalance between groups at an early stage of the study and identified the high percentage of participants in a students' age in the NDCs as a possible reason. While the financial incentive may have been appealing particularly for younger, healthy subjects, DCs' participation in the SIDE studies may have been driven more by the opportunity to benefit from the subsequent CBCT ® couple therapy (73). Despite the development of strategies to recruit older couples in the NDCs group (e.g.…”