Social Interaction and Compassion in Depression

NCT ID: NCT03080025

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-08-31

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?

Conditions

Depression; Couples (Persons)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CBCT® (Cognitively Based Compassion-Training)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Beate Ditzen

Prof. Dr. phil. Dipl.- Psych. Beate Ditzen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beate Ditzen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Psychology, University Hospital Heidelberg

Locations

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

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35580123 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30287601 (View on PubMed)

Other Identifiers

Ethics Commission

Identifier Type: OTHER

Identifier Source: secondary_id

IMP-CBC-247

Identifier Type: -

Identifier Source: org_study_id