Couples Coping With Multiple Chronic Medical Conditions (GUGKS)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014