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

BMJ Open. 2018 Oct 4;8(9):e020448. doi: 10.1136/bmjopen-2017-020448.

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.

Keywords: mindfulness- and compassion based intervention; psychobiological indicators of health; study protocol.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cognitive Behavioral Therapy / methods*
  • Couples Therapy / methods*
  • DNA Methylation
  • Depression / therapy*
  • Empathy*
  • Eye Movement Measurements
  • Female
  • Heart Rate
  • Humans
  • Hydrocortisone / metabolism
  • Interleukin-1beta / blood
  • Interleukin-6 / blood
  • Interpersonal Relations*
  • Male
  • Psychiatric Status Rating Scales
  • Randomized Controlled Trials as Topic
  • Receptors, Oxytocin / genetics
  • Saliva / metabolism
  • Serotonin Plasma Membrane Transport Proteins / genetics
  • alpha-Amylases / metabolism

Substances

  • Interleukin-1beta
  • Interleukin-6
  • OXTR protein, human
  • Receptors, Oxytocin
  • SLC6A4 protein, human
  • Serotonin Plasma Membrane Transport Proteins
  • alpha-Amylases
  • Hydrocortisone

Associated data

  • ClinicalTrials.gov/NCT03080025