Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT02593734
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000639', 'term': 'Amitriptyline'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions(CGI)', 'timeFrame': '6 weeks'}, {'measure': 'Global Assessment of functioning(GAF)', 'timeFrame': '6 weeks'}, {'measure': 'De-chaining,', 'timeFrame': '6 weeks', 'description': 'The number of days in each week that the patient was NOT restrained with physical restraints such as chains'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Mood Disorders,', 'Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '29433613', 'type': 'DERIVED', 'citation': 'Ofori-Atta A, Attafuah J, Jack H, Baning F, Rosenheck R; Joining Forces Research Consortium. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial. Br J Psychiatry. 2018 Jan;212(1):34-41. doi: 10.1192/bjp.2017.12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.', 'detailedDescription': 'The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.\n\nIn the proposed study, residents of the sanatorium at the Mount Horeb Prayer Center located in Mamfe, Ghana will be screened for psychiatric disorders by a psychiatrist. Those who are diagnosed with a psychiatric disorder requiring treatment (schizophrenia, or mood disorder) and who meet the other inclusion criteria (see below) will be randomly assigned to receive a daily dose of the appropriate psychotropic drug (according to standard procedures of care) as well as regular prayer camp treatment (intervention group) or to receive only regular prayer camp treatment (control group). After randomization, the patients in the intervention group will receive the bundled treatment for 6 weeks, while control group patients will receive regular prayer camp treatment, e.g. encouragement to pray. Psychiatrists blinded to group assignments will assess outcomes over a 6 - 8 week period. Following this, patients will be referred for continued care with health care facilities as close to their homes as possible on discharge and if they so desire. At the start of the intervention, pastors and attendants at the prayer camp will be qualitatively assessed through a semi-structured interview concerning their attributions of mental illness causation. They will be assessed -0, -6 weeks after and again -12 weeks after intervention. The investigators hypothesize that patients who receive the bundled intervention will have improved mental health outcomes and functioning and that prayer camp staff will develop more positive attitudes toward conventional medicine and will begin to conceptualize mental health disorders as treatable illnesses, rather than only as a spiritual disorder. The results will provide empirical evidence for or against an integrated model of community based care which encompasses the medical and spiritual. This is the first intervention study in Sub-Saharan Africa to promote the use of psychotropic drugs in a traditional or spiritual healing setting. Its findings may inform the implementation of national policies governing collaboration between primary health care and faith healing centers, expanding access to and improving the quality of mental health care services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\> 18 years,\\<70\n2. Will benefit from treatment\n3. Not suffering from physical condition\n4. Resident at the prayer camp\n5. Not likely to be discharged from camp within six weeks\n6. Speaks either English or twi\n7. Able to give consent\n8. Not already on medication\n\nExclusion Criteria:\n\n1. likely to be discharged within 6 weeks of commencement of medication\n2. Patients already on medication'}, 'identificationModule': {'nctId': 'NCT02593734', 'acronym': 'JFR', 'briefTitle': 'Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana', 'organization': {'class': 'OTHER', 'fullName': 'University of Ghana Medical School'}, 'officialTitle': 'Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana', 'orgStudyIdInfo': {'id': 'JFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'The intervention is prescription and dispensing by a nurse of oral antipsychotic or antidepressant medication as clinically indicated. The mediations to be selected from include oral olanzapine, risperidone, amitryptaline or fluoxetine at doses prescribed by the treating psychiatrist.', 'interventionNames': ['Drug: olanzapine', 'Drug: risperidone', 'Drug: amitryptaline', 'Drug: fluoxetine']}], 'interventions': [{'name': 'olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'oral antipsychotic drug therapy', 'armGroupLabels': ['Experimental']}, {'name': 'risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': 'oral antipsychotic drug therapy', 'armGroupLabels': ['Experimental']}, {'name': 'amitryptaline', 'type': 'DRUG', 'otherNames': ['Elavil'], 'description': 'oral antidepressant drug therapy', 'armGroupLabels': ['Experimental']}, {'name': 'fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': 'oral drug therapy for depression', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00233', 'city': 'Mamfe', 'country': 'Ghana', 'facility': 'Mount Horeb Prayer Centre', 'geoPoint': {'lat': 5.93848, 'lon': -0.11986}}], 'overallOfficials': [{'name': 'Angela L Ofori-Atta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ghana Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ghana Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}