Clinical trial NCT03080025: Social Interaction and Compassion in Depression
Official title: The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Couples (Persons)
Keywords: CBCT® (Cognitively Based Compassion-Training)
Psychobiological Evaluation
Real Time Social Interaction
Eye-Tracking
Heart Rate Variability
IL-6
IL-1b
Cortisol
Alpha-Amylase
Randomised Controlled Trial
Compassion
Empathy
Relationship Quality
Interpersonal Relations
Stress
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Arizona
name: University Hospital Heidelberg
First posted: 2017-03-15
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how a CBCT® (Cognitively Based Compassion-Training) for couples affect aspects of health and especially social interactions in depressed female patients and their romantic partners. compare healthy and depressed couples during an instructed positive real-time social interaction in the laboratory.

Furthermore the investigators aim to examine how social behavior and psychobiological indicators of health during real-time social interaction in the laboratory might be improved through CBCT® for couples.

Detailed description: Objects:

Will a CBCT® (Cognitively Based Compassion-Training) for couples reduce the depressive symptomatic and the partners´ burden as well as improve behavioral, endocrine, physiological and immune responses during a real time social interaction in the laboratory.

Do couples with a depressed female partner differ from healthy control couples in behavioral, endocrine, physiological and immune responses during a instructed positive real-time social interaction in a laboratory setting?

Eligibility criteria: General inclusion criteria:

* being in a heterosexual relationship for two years or more
* agreement to participate in the study
* recurrent depression (ICD-10 F33.0 or F33.1, depressed females of the patient couples only)
* agreement of the patient couples to be randomized into the two treatment arms
* no mental disorders (healthy control group only)

General exclusion criteria:

* severe acute and chronic psychological ( suicidal tendency, acute affective bipolar disorders) or physical disorder (chronic diseases, severe diseases such as endocrinological, neurological, nephrological or hepatic disorders)
* being pregnant
* heavy smoking (more than 20 cigarettes daily) or alcohol abuse
* substance related abuse and addiction
* enrolling current couple therapy
* enrolling current individual therapy (except of probatory phase)
* enrolling current mindfulness or compassion based group training

Primary outcomes:
measure: Depressive symptoms
timeFrame: 4 weeks after recruitment and 12 weeks after first test
measure: Eye gaze patterns
timeFrame: 4 weeks after recruitment and 12 weeks after first test
measure: Circadian variation pattern of heart rate variability
timeFrame: 4 weeks after recruitment and 12 weeks after first test
Secondary outcomes:
measure: Analysis of psychometrical self- and observer rating und their correlations
timeFrame: 4 weeks after recruitment and 12 weeks after first test
measure: Biopsychological concomitants of depressive disorders
timeFrame: 4 weeks after recruitment and 12 weeks after first test
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg
Study officials:
affiliation: Institute of Medical Psychology, University Hospital Heidelberg
name: Beate Ditzen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winter F, Mander J, Jarczok MN, Warth M, Negi LT, Harrison T, Ditzen B, Aguilar-Raab C. Change Mechanism of Cognitively-Based Compassion Training for Couples with Depression: An Exploratory Empirical Investigation of Process Variables. J Integr Complement Med. 2022 Jul;28(7):591-599. doi: 10.1089/jicm.2022.0497. Epub 2022 May 17.
citation: Aguilar-Raab C, Jarczok MN, Warth M, Stoffel M, Winter F, Tieck M, Berg J, Negi LT, Harrison T, Pace TWW, Ditzen B. 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.