- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912157
Couples Coping With Multiple Chronic Medical Conditions (GUGKS)
Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?
Handling of complex health situations (as defined by multimorbidity) in partnership: communication between romantic partners; subjective illness perception; coping with stressful experiences due to multimorbidity.
Intervention : Expressive Writing about subjective illness perception vs. Writing about individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire) Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of partnership and others)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coping in complex health situations (as defined by multimorbidity) and the role of relationship processes for psycho-social adaption: The study investigates interpersonal emotion regulation, disclosure, and illness perceptions in couples with a multimorbid patient. The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing), the control condition are 3 sessions writing about individual time-management (placebo).
Primary endpoint: subjective health (SF 12 questionnaire) Secondary endpoint: psychosocial adjustments (depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Age 18 or older
- multimorbid condition (two or more chronic medical conditions)
- patients living with romantic partner
- very good oral and written command in German
- written consent for participation by patient and partner
Exclusion criteria:
- Pregnancy
- Mini Mental State less than 26
- Substance Abuse
- Patients in Palliative Situation
- Patients isolated due to infectious diseases
- Patients participating in other clinical trials within the last 4 weeks before inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: No Intervention
The control condition are 3 sessions writing about individual time-management (placebo).
|
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)
|
Active Comparator: Expressive Writing
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing).
|
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective health (SF-12)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial adjustments
Time Frame: 3 months
|
depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lukas Zimmerli, MD, University Hospital Zurich, Internal Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH 2013-0009_GUGKS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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