Couples Coping With Multiple Chronic Medical Conditions

NCT ID: NCT01912157

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-12-28

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Chronic Disease Illness Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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No Intervention

The control condition are 3 sessions writing about individual time-management (placebo).

Group Type PLACEBO_COMPARATOR

Expressive Writing

Intervention Type BEHAVIORAL

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

Expressive Writing

The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing).

Group Type ACTIVE_COMPARATOR

Expressive Writing

Intervention Type BEHAVIORAL

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

Interventions

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Expressive Writing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukas Zimmerli, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Internal Medicine

Locations

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University Hospital Zurich, Internal Medicine

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH 2013-0009_GUGKS

Identifier Type: -

Identifier Source: org_study_id