Social Interaction and Compassion in Depression (SIDE)

August 4, 2021 updated by: Beate Ditzen, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBCT® for Couples

The CBCT® (Cognitively Based Compassion-Training) for couples (CBCT®-fC) consists of a ten-week training program with a 2h group session weekly and daily home practice based on prerecorded guided mediations (Emory University, Atlanta, USA; Ozawa-de Silva & Negi, 2013). The ten weeks start with an overview and a take-home ideas for continuing practice. Furthermore the first and the 3rd module will be repeated once resulting in a total of ten weeks. Further couple- and dyadic exercises are added.

It focuses on six essential key parts for the development of compassion:

  1. Developing attentional stability and clarity of the mind (Mindfulness)
  2. Cultivating insight into the nature of mental experience
  3. Cultivating self-compassion
  4. Developing impartiality
  5. Developing appreciation and affection for others
  6. Developing empathy and realizing engaged compassion
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.
No Intervention: Treatment as usual (TAU)
Treatment as usual: Primary care according to guidelines from the S3- and national healthcare guideline "Unipolar Depression" [S3-Leitlinie und Nationale VersorgungsLeitlinie (NVL) Unipolare Depression, Ärztliches Zentrum für Qualität in der Medizin], but excluding current psychotherapy after probatory session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 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).
4 weeks after recruitment and 12 weeks after first test
Eye gaze patterns
Time Frame: 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.
4 weeks after recruitment and 12 weeks after first test
Circadian variation pattern of heart rate variability
Time Frame: 4 weeks after recruitment and 12 weeks after first test
Changes in circadian variation pattern of heart rate variability pre & post training.
4 weeks after recruitment and 12 weeks after first test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of psychometrical self- and observer rating und their correlations
Time Frame: 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)
4 weeks after recruitment and 12 weeks after first test
Biopsychological concomitants of depressive disorders
Time Frame: 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.
4 weeks after recruitment and 12 weeks after first test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Emory University
University Hospital Heidelberg
University of Arizona

Investigators

  • Principal Investigator: Beate Ditzen, Prof. Dr., Institute of Medical Psychology, University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP-CBC-247
  • Ethics Commission (Other Identifier: S-021/2016)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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