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: Completed
• Conditions: Chronic Disease; Illness Behavior
• Intervention / Treatment: Behavioral: Expressive Writing

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No Intervention; The control condition are 3 sessions writing about individual time-management (placebo).	Behavioral: Expressive Writing; 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).	Behavioral: 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)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial adjustments	depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality	3 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Lukas Zimmerli, MD, University Hospital Zurich, Internal Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Illness Behavior
• Other Study ID Numbers: KEK-ZH 2013-0009_GUGKS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No