Couples Coping With Multiple Chronic Medical Conditions (GUGKS)

This study is currently recruiting participants.
Verified July 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01912157
First received: July 24, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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)


Condition Intervention
Chronic Disease
Illness Behavior
Behavioral: Expressive Writing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Subjective health (SF-12) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial adjustments [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: No Intervention
The control condition are 3 sessions writing about individual time-management (placebo).
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)

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912157

Contacts
Contact: Lukas Zimmerli, MD +41 (0)44 255 11 11 lukas.zimmerli@usz.ch

Locations
Switzerland
University Hospital Zurich, Internal Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Lukas Zimmerli, MD University Hospital Zurich, Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01912157     History of Changes
Other Study ID Numbers: KEK-ZH 2013-0009_GUGKS
Study First Received: July 24, 2013
Last Updated: July 29, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014