Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT01912157
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Couples Coping With Multiple Chronic Medical Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D055809', 'term': 'Illness Behavior'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-28', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective health (SF-12)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Psychosocial adjustments', 'timeFrame': '3 months', 'description': 'depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Disease', 'Illness Behavior']}, 'descriptionModule': {'briefSummary': '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.\n\nIntervention : 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)', 'detailedDescription': '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).\n\nPrimary endpoint: subjective health (SF 12 questionnaire) Secondary endpoint: psychosocial adjustments (depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 18 or older\n* multimorbid condition (two or more chronic medical conditions)\n* patients living with romantic partner\n* very good oral and written command in German\n* written consent for participation by patient and partner\n\nExclusion criteria:\n\n* Pregnancy\n* Mini Mental State less than 26\n* Substance Abuse\n* Patients in Palliative Situation\n* Patients isolated due to infectious diseases\n* Patients participating in other clinical trials within the last 4 weeks before inclusion'}, 'identificationModule': {'nctId': 'NCT01912157', 'acronym': 'GUGKS', 'briefTitle': 'Couples Coping With Multiple Chronic Medical Conditions', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?', 'orgStudyIdInfo': {'id': 'KEK-ZH 2013-0009_GUGKS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'No Intervention', 'description': 'The control condition are 3 sessions writing about individual time-management (placebo).', 'interventionNames': ['Behavioral: Expressive Writing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Expressive Writing', 'description': 'The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing).', 'interventionNames': ['Behavioral: Expressive Writing']}], 'interventions': [{'name': 'Expressive Writing', 'type': 'BEHAVIORAL', 'description': 'The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)', 'armGroupLabels': ['Expressive Writing', 'No Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Internal Medicine', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Lukas Zimmerli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}