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Completed

NCT Number: NCT03080025

Social Interaction and Compassion in Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Couples (Persons)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Heidelberg, 69115, Germany

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBCT® (Cognitively Based Compassion-Training)

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Emory University
  • University Hospital Heidelberg
  • University of Arizona

Registry information

Official study title

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

Acronym: SIDE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2017
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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