We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Couples Coping With Multiple Chronic Medical Conditions (GUGKS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01912157
First Posted: July 30, 2013
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  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 (Participant)
Primary Purpose: Other
Official Title: Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Subjective health (SF-12) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Psychosocial adjustments [ Time Frame: 3 months ]
    depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality


Enrollment: 22
Study Start Date: July 2013
Estimated Study Completion Date: December 1, 2018
Primary Completion Date: April 1, 2017 (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).
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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912157


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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01912157     History of Changes
Other Study ID Numbers: KEK-ZH 2013-0009_GUGKS
First Submitted: July 24, 2013
First Posted: July 30, 2013
Last Update Posted: April 19, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Disease
Illness Behavior
Multiple Chronic Conditions
Disease Attributes
Pathologic Processes