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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
  1. Corina Aguilar-Raab1,1,
  2. Marc N Jarczok1,2,
  3. Marco Warth1,
  4. Martin Stoffel1,
  5. Friederike Winter1,
  6. Maria Tieck1,
  7. Judith Berg1,
  8. Lobsang Tenzin Negi3,
  9. Tim Harrison4,
  10. Thaddeus W W Pace5,6,7,
  11. Beate Ditzen1
  1. 1 Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany
  2. 2 Department of Psychosomatic Medicine and Psychotherapy, University Clinic Ulm, Ulm, Germany
  3. 3 Department of Religion, Emory-Tibet Partnership, Center for Contemplative Science and Compassion-Based Ethics, Emory College, Emory University, Atlanta, Georgia, USA
  4. 4 Emory-Tibet Partnership, Center for Contemplative Science and Compassion-Based Ethics, CBCT® Teacher Training, Emory University, Atlanta, Georgia, USA
  5. 5 College of Nursing, University of Arizona, Tucson, Arizona, USA
  6. 6 Department of Psychiatry, College of Medicine, University of Arizona, Tucson, Arizona, USA
  7. 7 Department of Psychology, College of Science, University of Arizona, Tucson, Arizona, USA
  1. Correspondence to Dr Corina Aguilar-Raab; corina.aguilar-raab{at}med.uni-heidelberg.de

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.

  • study protocol
  • mindfulness- and compassion based intervention
  • psychobiological indicators of health

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • CA-R and MNJ contributed equally.

  • Contributors CA-R and MNJ drafted the first version of the manuscript sharing the first authorship as they contributed equally. MT and JB supported this process. BD, LTN, TH and TWWP delivered feedback on a first version of the paper—LTN and TH focusing especially on the CBCT-fC part. CA-R, MNJ, MW, FW and TWWP critically revised the second version of the manuscript for important intellectual content with regard to psychobiological assessments, and additionally TWWP did the English copyediting. While revising the manuscript, MS was engaged specifically with rewriting the parts on epigenetics. CA-R, MNJ and BD contributed to the design of the study. All authors have approved the final version of the manuscript.

  • Funding The study is mainly funded by the Institute of Medical Psychology, University Hospital Heidelberg and partly by the Mind and Life Organization as well as by the Deutsche Gesellschaft für Systemische Therapie, Beratung und Familientherapie. Further funding is pending.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Ethics Committee of the Medical Faculty Heidelberg, Heidelberg University, Germany (S-021/2016).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Research data will be made available for future research by other researchers anonymously via the Competence Centre for Research Data (Heidelberg University) using the platform heiDATA (the university’s research data repository) in line with its Research Data Policy adopted by Heidelberg University: http://www.data.uni-heidelberg.de/services.html. Confidential information of all participants is subject to data protection. Data will only be passed on to third parties in a deidentified format (ie, all protected health information removed).