Social Interaction and Compassion in Depression - Clinical Trial for Depression | NCT03080025

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

CBCT® (Cognitively Based Compassion-Training)

About this trial

This is an interventional treatment trial for Depression focused on measuring 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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBCT® for Couples

Treatment as usual (TAU)

Arm Description

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: Developing attentional stability and clarity of the mind (Mindfulness) Cultivating insight into the nature of mental experience Cultivating self-compassion Developing impartiality Developing appreciation and affection for others Developing empathy and realizing engaged compassion

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.

Outcomes

Primary Outcome Measures

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).

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.

Circadian variation pattern of heart rate variability

Changes in circadian variation pattern of heart rate variability pre & post training.

Secondary Outcome Measures

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)

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.

Full Information

NCT ID

NCT03080025

First Posted

October 25, 2016

Last Updated

August 4, 2021

Sponsor

Heidelberg University

Collaborators

Emory University, University of Arizona, University Hospital Heidelberg

1. Study Identification

Unique Protocol Identification Number

NCT03080025

Brief Title

Social Interaction and Compassion in Depression

Acronym

SIDE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

Collaborators

Emory University, University of Arizona, University Hospital Heidelberg

4. Oversight

Data Monitoring Committee

No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBCT® for Couples

Arm Type

Experimental

Arm Description

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: Developing attentional stability and clarity of the mind (Mindfulness) Cultivating insight into the nature of mental experience Cultivating self-compassion Developing impartiality Developing appreciation and affection for others Developing empathy and realizing engaged compassion

Arm Title

Treatment as usual (TAU)

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

CBCT® (Cognitively Based Compassion-Training)

Intervention Description

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 Outcome Measure Information:

Title

Depressive symptoms

Description

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).

Time Frame

4 weeks after recruitment and 12 weeks after first test

Title

Eye gaze patterns

Description

Changes in eye gaze patterns (total fixation time & fixation count) as behavioural component measured during standardised positive social interaction- pre & post training.

Time Frame

4 weeks after recruitment and 12 weeks after first test

Title

Circadian variation pattern of heart rate variability

Description

Changes in circadian variation pattern of heart rate variability pre & post training.

Time Frame

4 weeks after recruitment and 12 weeks after first test

Secondary Outcome Measure Information:

Title

Analysis of psychometrical self- and observer rating und their correlations

Description

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)

Time Frame

4 weeks after recruitment and 12 weeks after first test

Title

Biopsychological concomitants of depressive disorders

Description

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.

Time Frame

4 weeks after recruitment and 12 weeks after first test

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beate Ditzen, Prof. Dr.

Organizational Affiliation

Institute of Medical Psychology, University Hospital Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

35580123

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.

Results Reference

derived

PubMed Identifier

30287601

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.

Results Reference

derived

Social Interaction and Compassion in Depression (SIDE)

Depression, Couples (Persons)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial