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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01912157
Other study ID # KEK-ZH 2013-0009_GUGKS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date December 28, 2018

Study information

Verified date December 2018
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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)


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 28, 2018
Est. primary completion date April 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Expressive Writing
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)

Locations

Country Name City State
Switzerland University Hospital Zurich, Internal Medicine Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective health (SF-12) 3 months
Secondary Psychosocial adjustments depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality 3 months
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