Social Interaction and Compassion in Depression

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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Depression, Couples (Persons)

Intervention / Treatment
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* Behavioral: CBCT® (Cognitively Based Compassion-Training)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBCT® for Couples<br>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 | Behavioral: CBCT® (Cognitively Based Compassion-Training)<br>* 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.<br>|
| No Intervention: Treatment as usual (TAU)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4 weeks after recruitment and 12 weeks after first test | 
| 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. | 4 weeks after recruitment and 12 weeks after first test | 
| Circadian variation pattern of heart rate variability | Changes in circadian variation pattern of heart rate variability pre & post training. | 4 weeks after recruitment and 12 weeks after first test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 weeks after recruitment and 12 weeks after first test | 
| 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. | 4 weeks after recruitment and 12 weeks after first test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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