Skip to content

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.

Corina Aguilar-Raab, Marc N Jarczok, Marco Warth, Martin Stoffel, Friederike Winter, Maria Tieck, Judith Berg, Lobsang Tenzin Negi, Tim Harrison, Thaddeus W W Pace, Beate Ditzen

BMJ Open October 4, 2018 DOI: 10.1136/bmjopen-2017-020448 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Study protocol for a randomized controlled trial Peer reviewed
Population Couples in which the female partner has depression
Intervention Treatment as usual
Duration 10 weeks
Measures Hamilton Depression Rating Scale, Beck Depression Inventory, eye tracking, cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability, methylation of oxytocin-receptor-genes and serotonin-transporter-genes, self-ratings of relationship quality and empathy
Topics Depression
Keywords Saliva Humans Hydrocortisone Receptors, oxytocin Interleukin-6 Empathy Interpersonal relations Couples therapy Dna methylation Heart rate Female Interleukin-1beta Eye movement measurements Alpha-amylases Cognitive behavioral therapy Study protocol
Registration NCT03080025
Key findings The protocol proposes to test whether a 10-week couples-adapted Cognitively Based Compassion Training (CBCT®-fC) reduces depressive symptoms (primary outcome: Hamilton Depression Rating Scale) and improves distress, social interaction skills, and neurobiological stress regulation compared with treatment as usual. The authors note that randomized trials of such compassion training are scarce and that prior programs did not include the patient's romantic partner.

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, 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 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.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

Citations in the library

Explore topics