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Social Interaction and Compassion in Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03080025
Acronym
SIDE
Enrollment
140
Registered
2017-03-15
Start date
2017-01-31
Completion date
2019-08-31
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Couples (Persons), Depression

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

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?

Interventions

BEHAVIORALCBCT® (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.

Sponsors

Emory University
CollaboratorOTHER
University of Arizona
CollaboratorOTHER
University Hospital Heidelberg
CollaboratorOTHER
Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Eye gaze patterns4 weeks after recruitment and 12 weeks after first testChanges in eye gaze patterns (total fixation time & fixation count) as behavioural component measured during standardised positive social interaction- pre & post training.
Depressive symptoms4 weeks after recruitment and 12 weeks after first testChange 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).
Circadian variation pattern of heart rate variability4 weeks after recruitment and 12 weeks after first testChanges in circadian variation pattern of heart rate variability pre & post training.

Secondary

MeasureTime frameDescription
Analysis of psychometrical self- and observer rating und their correlations4 weeks after recruitment and 12 weeks after first testSelf- 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 disorders4 weeks after recruitment and 12 weeks after first testSaliva 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026