Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-28 @ 9:31 AM
Study NCT ID:
NCT04230135
Status:
TERMINATED
Last Update Posted:
2022-05-25
First Post:
2020-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'An insufficient number of participants could be recruited, and drop-out rates were very high (80%)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological distress', 'timeFrame': 'Six weeks', 'description': 'Hopkins Symptom Checklist-25 (HSCL-25)'}, {'measure': 'Treatment adherence', 'timeFrame': 'Six weeks', 'description': 'Completing at least three (out of five) sessions of Hap-pas-Hapi;'}], 'secondaryOutcomes': [{'measure': 'Functional impairment (health and disability)', 'timeFrame': 'Six weeks', 'description': 'WHO Disability Assessment Schedule (WHODAS 2.0)'}, {'measure': 'Well-being', 'timeFrame': 'Six weeks', 'description': 'The WHO Wellbeing Index (WHO-5)'}, {'measure': 'Post-traumatic stress disorder', 'timeFrame': 'Six weeks', 'description': 'The PTSD checklist, 8 items version (PCL-8)'}, {'measure': 'Self-defined problems', 'timeFrame': 'Six weeks', 'description': 'The Psychological Outcome Profiles (PSYCHLOPS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Distress']}, 'descriptionModule': {'briefSummary': "We aim to compare two different levels of cultural adaptation of an Internet- and mobile-based intervention for the treatment of depression called Hap-pas-Hapi among Albanian-speaking immigrants in Switzerland and Germany. One arm will include the generic (minimally adapted) version of Hap-pas Hapi. The other arm will include a version of Hap-pas-Hapi that was adapted to the target population's cultural concepts of distress. Both versions include five sessions and the same therapeutic techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Electronic informed consent documented by time-stamped agreement to a set of consent questions\n* Albanian-speaking\n* Male and female participants aged above 18\n* Kessler Psychological Distress Scale (K10), Albanian version score \\>15\n* Access to Smartphone (iOS or Android) or web-browser\n\nExclusion Criteria:\n\n* People living outside Germany or Switzerland\n* Serious suicidal thoughts or plan (self-assessed with a corresponding question)'}, 'identificationModule': {'nctId': 'NCT04230135', 'briefTitle': 'Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': "Randomised Controlled Trial to Test to What Extent the Adaptation of a Smartphone-based Self-help Programme to Albanian Immigrants' Cultural Concepts of Distress Enhances Its Acceptability and Efficacy", 'orgStudyIdInfo': {'id': 'Hap-pas-Hapi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Generic (surface adaptation)', 'description': 'The generic version of Hap-pas-Hapi includes only surface adaptations (i.e., adaptation of text and illustrations that are inacceptable or non-meaningful for the target group)', 'interventionNames': ['Device: Hap-pas-Hapi']}, {'type': 'EXPERIMENTAL', 'label': 'Adapted (deep structure adaptation)', 'description': "For the experimental intervention, Hap-pas-Hapi was adapted to Albanian immigrants' cultural concepts of distress (CCD). An ethnopsychological study was conducted for this purpose, since evidence on CCD in South Eastern Europe is scarce. Based on this study, three deep-structure adaptations were done: i) the symptom narrative provided by the narrator in the app was re-written to reflect Albanian immigrants' CCD; ii) a new explanatory model builder was implemented to address the target group's fatalistic beliefs; and iii) a goal-setting task was programmed to address the target group's socio-centric notion of the self.", 'interventionNames': ['Device: Hap-pas-Hapi']}], 'interventions': [{'name': 'Hap-pas-Hapi', 'type': 'DEVICE', 'description': 'Hap-pas-Hapi is a Smartphone-based intervention for the treatment of psychological distress. It includes five sessions and uses a narrative approach. Behavioural activation is the main active therapeutic agent in the intervention, along with stress management, positive self-talk, mood tracking, social support, and relapse prevention.', 'armGroupLabels': ['Adapted (deep structure adaptation)', 'Generic (surface adaptation)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Freie Universität Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '8050', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Freie Universität Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}