Social Interaction and Compassion in Depression

Depression Clinical Trial

— SIDE  

Official title:

The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080025
• Other study ID #: IMP-CBC-247
• Secondary ID: Ethics Commissio
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2019

Study information

• Verified date: August 2021
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• CBCT® (Cognitively Based Compassion-Training)
The CBCT® (Cognitively Based Compassion-Training) as a secular approach was established as a structured protocol. The therapeutic tools are based on systemic approaches & techniques, which contains a resource- & solution orientation and the approach of Gottman's model of healthy relationships (e.g. trust and commitment - based on that - elements like "the positive perspective"). Four dyadic exercises are introduced to enhance positive reciprocity between the romantic partners (based on concepts of couple communication training): a) Building mindful ability to talk, b) building mindful ability to listen (without reacting initially), c) appreciation in action - indulging the partner, d) "noticing, how the partner is doing something good for me" - gratefulness in action verbally/non-verbally. Finally, the "empathy exercise" has been added inspired by CBASP therapy for chronic major depression.

Locations

Country	Name	City	State
Germany	Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg	Heidelberg

Sponsors (4)

Lead Sponsor	Collaborator
Heidelberg University	Emory University, University Hospital Heidelberg, University of Arizona

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	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).	4 weeks after recruitment and 12 weeks after first test
Primary	Eye gaze patterns	Changes in eye gaze patterns (total fixation time & fixation count) as behavioural component measured during standardised positive social interaction- pre & post training.	4 weeks after recruitment and 12 weeks after first test
Primary	Circadian variation pattern of heart rate variability	Changes in circadian variation pattern of heart rate variability pre & post training.	4 weeks after recruitment and 12 weeks after first test
Secondary	Analysis of psychometrical self- and observer rating und their correlations	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)	4 weeks after recruitment and 12 weeks after first test
Secondary	Biopsychological concomitants of depressive disorders	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.	4 weeks after recruitment and 12 weeks after first test