Back to resultsCouples Coping With Multiple Chronic Medical Conditions (GUGKS)
Primary Purpose
Chronic Disease, Illness Behavior
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Expressive Writing
Sponsored by
About this trial
This is an interventional other trial for Chronic Disease
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
No Intervention
Expressive Writing
Arm Description
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).
Outcomes
Primary Outcome Measures
Subjective health (SF-12)
Secondary Outcome Measures
Psychosocial adjustments
depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01912157
Brief Title
Couples Coping With Multiple Chronic Medical Conditions
Acronym
GUGKS
Official Title
Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Illness Behavior
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
The control condition are 3 sessions writing about individual time-management (placebo).
Arm Title
Expressive Writing
Arm Type
Active Comparator
Arm Description
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing).
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Description
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)
Primary Outcome Measure Information:
Title
Subjective health (SF-12)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Psychosocial adjustments
Description
depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Zimmerli, MD
Organizational Affiliation
University Hospital Zurich, Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Internal Medicine
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Couples Coping With Multiple Chronic Medical Conditions
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