Social Interaction and Compassion in Depression

Not Applicable

Completed

• Conditions: Depression; Couples (Persons)

• Registration Number: NCT03080025
• Lead Sponsor: Heidelberg University

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?

Study Timeline

• Study First Submitted: 2016-10-25
• Study Start: 2017-01
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Primary Completion: 2019-04
• Study Completion: 2019-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eye gaze patterns	4 weeks after recruitment and 12 weeks after first test	Changes in eye gaze patterns (total fixation time \& fixation count) as behavioural component measured during standardised positive social interaction- pre \& post training.
Circadian variation pattern of heart rate variability	4 weeks after recruitment and 12 weeks after first test	Changes in circadian variation pattern of heart rate variability pre \& post training.
Depressive symptoms	4 weeks after recruitment and 12 weeks after first test	Change in depression score (observer rating Hamilton Depression Rating Scale \[HDRS\], self-rating Becks Depression Inventory \[BDI\]) after CBCT® (Cognitively Based Compassion Training) for couples in comparison to control TAU-group (treatment as usual).

Secondary Outcome Measures

Name	Time	Method
Analysis of psychometrical self- and observer rating und their correlations	4 weeks after recruitment and 12 weeks after first test	Self- and observer ratings are: Berliner Social Support Skalen (BSSS) Compassionate Love Scale (CLS) Empathy Quotient (EQ) EuroQol five dimensions questionnaire (EQ5D) Evaluation of Social Systems (EVOS) UCLA-LS (HES) Inventory Interpersonal Probleme (IIP) Kentucky Inventory of Mindfulness Skills (KIMS) Partner Burden in Depression (PBD) Partnership Questionnaire (PFB) Patient Health Questionnaire (PHQ-9) Self Compassion Scale (SCS) Trier Inventar zum chronischen Stress (TICS)
Biopsychological concomitants of depressive disorders	4 weeks after recruitment and 12 weeks after first test	Saliva cortisol \& alpha amylase, HbA1c, immune reactivity (Interleukin 1 beta \[IL1b\], Interleukin 6 \[IL6\], C-reactive protein \[CRP\]) and in epigenetical parameters (OXTR, SLC6A4) pre \& post training.

Trial Locations

Locations (1)

Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany