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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Commission | Other Identifier | S-021/2016 |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of Arizona | OTHER |
| University Hospital Heidelberg | OTHER |
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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBCT® for Couples | Experimental | 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:
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| Treatment as usual (TAU) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCT® (Cognitively Based Compassion-Training) | Behavioral | 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. |
| 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 |
| 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) |
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General inclusion criteria:
General exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beate Ditzen, Prof. Dr. | Institute of Medical Psychology, University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg | Heidelberg | 69115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35580123 | Derived | Winter F, Mander J, Jarczok MN, Warth M, Negi LT, Harrison T, Ditzen B, Aguilar-Raab C. Change Mechanism of Cognitively-Based Compassion Training for Couples with Depression: An Exploratory Empirical Investigation of Process Variables. J Integr Complement Med. 2022 Jul;28(7):591-599. doi: 10.1089/jicm.2022.0497. Epub 2022 May 17. | |
| 30287601 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
| Aguilar-Raab C, Jarczok MN, Warth M, Stoffel M, Winter F, Tieck M, Berg J, Negi LT, Harrison T, Pace TWW, Ditzen B. Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples. BMJ Open. 2018 Oct 4;8(9):e020448. doi: 10.1136/bmjopen-2017-020448. |