Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-31 @ 3:09 PM
Study NCT ID:
NCT02968667
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Learned Helplessness', 'timeFrame': 'Up to 6 months', 'description': 'Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)'}], 'secondaryOutcomes': [{'measure': 'Psychiatric symptoms', 'timeFrame': 'Up to 6 months', 'description': 'Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)'}, {'measure': 'recovery assessment scale', 'timeFrame': 'Up to 6 months', 'description': 'Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)'}, {'measure': 'Empowerment level', 'timeFrame': 'Up to 6 months', 'description': 'Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 6 months', 'description': 'Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.', 'detailedDescription': 'A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual \\[TAU\\] (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult aged 16 years or more\n* Able to read and write in an Arabic\n* Able to consent\n* Diagnosed with schizophrenia\n* Volunteers\n\nExclusion Criteria:\n\n* Learning disability\n* Not able to read or write'}, 'identificationModule': {'nctId': 'NCT02968667', 'briefTitle': 'The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fakeeh College for Medical Sciences'}, 'officialTitle': 'The Effectiveness of Hopelessness and Helplessness on Recovery Rate Among People Diagnosed With Schizophrenia', 'orgStudyIdInfo': {'id': 'FakeehCMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention group received 6 weeks of empowerment program', 'interventionNames': ['Behavioral: Empowerment']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Medications'}], 'interventions': [{'name': 'Empowerment', 'type': 'BEHAVIORAL', 'description': '6 weeks of empowerment program and supported face to face discussion', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakeeh College for Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Abd Alhadi Hasan', 'investigatorAffiliation': 'Fakeeh College for Medical Sciences'}}}}