Chronic DiseaseGUGKSNCT01912157
Couples Coping With Multiple Chronic Medical Conditions
A study testing Expressive Writing in people with Chronic Disease and Illness Behavior, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Illness Behavior
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?
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)
Read the 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)
- Conditions
- Chronic Disease, Illness Behavior
- Being tested
- Expressive Writing
- Medical subject headings
- Chronic Disease, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Placebo comparator | The control condition are 3 sessions writing about individual time-management (placebo). Receives: Behavioral: Expressive Writing |
| Expressive Writing | Active comparator | The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing). Receives: Behavioral: Expressive Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective health (SF-12)
Measured: 3 months
Secondary outcomes (1)
Psychosocial adjustments
depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion1 Apr 2017
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Zimmerli, MD, Principal investigator, University Hospital Zurich, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912157
- Sponsor's protocol ID
- KEK-ZH 2013-0009_GUGKS
- Acronym
- GUGKS
- Status last verified
- Dec 2018
- First submitted
- 24 Jul 2013
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?
- ClinicalTrials.gov ID
- NCT01912157
- Acronym / sponsor ID
- GUGKS / KEK-ZH 2013-0009_GUGKS
- Conditions
- Chronic Disease, Illness Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Placebo comparator | Behavioral: Expressive WritingThe control condition are 3 sessions writing about individual time-management (placebo). |
| Expressive Writing | Active comparator | Behavioral: Expressive WritingThe intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Mini Mental State less than 26
- Substance Abuse
- Patients in Palliative Situation
- Patients isolated due to infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive WritingThe intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing) | Behavioural | Expressive Writing, No Intervention |
Primary outcome
Subjective health (SF-12)
Time frame: 3 months
1 secondary outcome
Psychosocial adjustments
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Zimmerli, MD principal investigator
University Hospital Zurich, Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing in people with Chronic Disease and Illness Behavior, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective health (SF-12) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.