Social Interaction and Compassion in Depression (SIDE)

Heidelberg University

Status: Completed

Conditions: Couples (Persons); Depression

Treatments: Behavioral: CBCT® (Cognitively Based Compassion-Training)

Study type: Interventional

Funder types: Other

Identifiers

NCT03080025

IMP-CBC-247

Ethics Commission (Other Identifier)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 140 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

CBCT® for Couples

Experimental group

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: 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

Treatment:

Behavioral: CBCT® (Cognitively Based Compassion-Training)

Treatment as usual (TAU)

No Intervention group

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.