Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    NVL

Social Interaction and Compassion in Depression (SIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Emory University
University of Arizona
University Hospital Heidelberg
Information provided by (Responsible Party):
Beate Ditzen, Heidelberg University

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.


Condition or disease Intervention/treatment Phase
Depression Couples (Persons) Behavioral: CBCT® (Cognitively Based Compassion-Training) Not Applicable

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?


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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:

  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
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.



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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)


  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Corina Aguilar-Raab, Dr. sc. hum. Dipl.-Psych. +49 6221 56 8135 corina.aguilar-raab@med.uni-heidelberg.de
Contact: Marc N Jarczok, Dr. sc. hum. +49 6221 56 8135 marc.jarczok@gmail.com

Locations
Layout table for location information
Germany
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    corina.aguilar-raab@med.uni-heidelberg.de   
Contact: Marc N. Jarczok, Dr.    +49 6221 56 8436    marc.jarczok@gmail.de   
Principal Investigator: Beate Ditzen, Prof. Dr. phil. Dipl.- Psych.         
Sponsors and Collaborators
Heidelberg University
Emory University
University of Arizona
University Hospital Heidelberg
Investigators
Layout table for investigator information
Principal Investigator: Beate Ditzen, Prof. Dr. Institute of Medical Psychology, University Hospital Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Beate Ditzen, Prof. Dr. phil. Dipl.- Psych. Beate Ditzen, Heidelberg University
ClinicalTrials.gov Identifier: NCT03080025     History of Changes
Other Study ID Numbers: IMP-CBC-247
Ethics Commission ( Other Identifier: S-021/2016 )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Beate Ditzen, Heidelberg University:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders