DepressionSIDENCT03080025
Social Interaction and Compassion in Depression
A study testing CBCT® (Cognitively Based Compassion-Training) in people with Depression and Couples (Persons), run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Couples (Persons)
- What is being tested?
- CBCT® (Cognitively Based Compassion-Training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut of Medical Psychology at the Center for Psychosocial Medicine, University Hospital Heidelberg
Heidelberg, 69115
About this study
Official title: The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners
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.
Read the 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?
- Conditions
- Depression, Couples (Persons)
- Being tested
- CBCT® (Cognitively Based Compassion-Training)
- 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
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT® (Cognitively Based Compassion-Training)Behavioural
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):
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
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 Receives: Behavioral: CBCT® (Cognitively Based Compassion-Training) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 4 weeks after recruitment and 12 weeks after first test
Secondary outcomes (2)
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)
Measured: 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.
Measured: 4 weeks after recruitment and 12 weeks after first test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startJan 2017
- Primary completionApr 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of Arizona, University Hospital Heidelberg
- Responsible party
- Principal investigator, Beate Ditzen, Heidelberg University
- Investigators
- Beate Ditzen, Prof. Dr., Principal investigator, Institute of Medical Psychology, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080025
- Sponsor's protocol ID
- IMP-CBC-247
- Other IDs
- Ethics Commission
- Acronym
- SIDE
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2016
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35580123Aguilar-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.
PubMed 30287601
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners
- ClinicalTrials.gov ID
- NCT03080025
- Acronym / sponsor ID
- SIDE / IMP-CBC-247
- Conditions
- Depression, Couples (Persons)
- Keywords
- CBCT® (Cognitively Based Compassion-Training), Psychobiological Evaluation, Real Time Social Interaction, Eye-Tracking, Heart Rate Variability, IL-6, IL-1b, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Emory University, University of Arizona, University Hospital Heidelberg
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBCT® for Couples | Experimental | Behavioral: CBCT® (Cognitively Based Compassion-Training)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 |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBCT® for Couples |
Primary outcome
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.
2 secondary outcomes
Analysis of psychometrical self- and observer rating und their correlations
Time frame: 4 weeks after recruitment and 12 weeks after first test
Biopsychological concomitants of depressive disorders
Time frame: 4 weeks after recruitment and 12 weeks after first test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Derived from this study: PubMed 35580123Winter 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.
- Derived from this study: PubMed 30287601Aguilar-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Ditzen, Prof. Dr. principal investigator
Institute of Medical Psychology, University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT® (Cognitively Based Compassion-Training) in people with Depression and Couples (Persons), run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 4 weeks after recruitment and 12 weeks after first test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.