Social Interaction and Compassion in Depression (SIDE)
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|ClinicalTrials.gov Identifier: NCT03080025|
Recruitment Status : Unknown
Verified March 2017 by Beate Ditzen, Heidelberg University.
Recruitment status was: Recruiting
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Couples (Persons)||Behavioral: CBCT® (Cognitively Based Compassion-Training)||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: 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:
Behavioral: 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.
No Intervention: 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.
- Depressive symptoms [ Time Frame: 4 weeks after recruitment and 12 weeks after first test ]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 [ Time Frame: 4 weeks after recruitment and 12 weeks after first test ]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 [ Time Frame: 4 weeks after recruitment and 12 weeks after first test ]Changes in circadian variation pattern of heart rate variability pre & post training.
- Analysis of psychometrical self- and observer rating und their correlations [ Time Frame: 4 weeks after recruitment and 12 weeks after first test ]
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 [ Time Frame: 4 weeks after recruitment and 12 weeks after first test ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080025
|Contact: Corina Aguilar-Raab, Dr. sc. hum. Dipl.-Psych.||+49 6221 56 firstname.lastname@example.org|
|Contact: Marc N Jarczok, Dr. sc. hum.||+49 6221 56 email@example.com|
|Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg||Recruiting|
|Heidelberg, Germany, 69115|
|Contact: Corina Aguilar-Raab, Dr. sc. hum. Dipl.- Psych. +49 6221 56 8135 firstname.lastname@example.org|
|Contact: Marc N. Jarczok, Dr. +49 6221 56 8436 email@example.com|
|Principal Investigator: Beate Ditzen, Prof. Dr. phil. Dipl.- Psych.|
|Principal Investigator:||Beate Ditzen, Prof. Dr.||Institute of Medical Psychology, University Hospital Heidelberg|