Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-27 @ 11:37 PM
Study NCT ID:
NCT00862732
Status:
UNKNOWN
Last Update Posted:
2009-03-17
First Post:
2009-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Prevent Negative Thoughts of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-16', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of active suicidal ideations during the follow-up period', 'timeFrame': 'three months after the cessation of intervention'}], 'secondaryOutcomes': [{'measure': 'Impulsiveness Suicide attempts and completed suicides Client satisfaction Probability of common mental disorders Adherence to treatment regime Retention in the treatment regime Quality of life', 'timeFrame': 'three months after the cessation of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['active suicidal ideation', 'cognitive behavioural therapy', 'Sri Lanka', 'RCT'], 'conditions': ['Active Suicidal Ideations']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by trained therapists, to people with current active suicidal ideations, is efficacious as a secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by Medical Officers (Mental Health; MO (MH)) of government hospitals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 - 64 years\n* Self reported current active suicidal ideations\n* Ability to speak and write Sinhala\n\nExclusion Criteria:\n\n* An acute intent and planning of suicide\n* In-patient/out-patient treatment following an attempted suicide during the previous two-year period\n* A diagnosis of mental retardation\n* A diagnosis of sensory deficit\n* A diagnosis of alcohol abuse\n* A diagnosis of psychotic illness'}, 'identificationModule': {'nctId': 'NCT00862732', 'briefTitle': 'Study to Prevent Negative Thoughts of Life', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Research & Development Sri Lanka'}, 'officialTitle': 'A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations', 'orgStudyIdInfo': {'id': 'IRD/03-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Cognitive Behavioural Therapy', 'description': "Intervention group will receive a series of sessions of cognitive behaviour therapy. Delivery of CBT will be by three therapists; PI and two other Medical Officers. Each session will last for 30- 45 minutes and they will be delivered at the participant's residence (or at an alternative place of participant's choice) at two weeks intervals. They will be followed-up for three months from the cessation of CBT sessions.", 'interventionNames': ['Behavioral: Cognitive behavioural therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Treatment as usual', 'description': 'Will be referred to the MO(MH). They also will be followed-up for an equal length of time period as of the participants in the intervention group.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Cognitive behavioural therapy', 'type': 'BEHAVIORAL', 'description': "Will receive a series of sessions of cognitive behaviour therapy. Delivery of CBT will be by three therapists; PI and two other Medical Officers. Each session will last for 30- 45 minutes and they will be delivered at the participant's residence (or at an alternative place of participant's choice) at two weeks intervals. They will be followed-up for three months from the cessation of CBT sessions.", 'armGroupLabels': ['1 Cognitive Behavioural Therapy']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Will be referred to the MO(MH). They also will be followed-up for an equal length of time period as of the participants in the intervention group.', 'armGroupLabels': ['2 Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Battaramulla', 'country': 'Sri Lanka', 'facility': 'Institute for Research & Development', 'geoPoint': {'lat': 6.8964, 'lon': 79.9181}}], 'centralContacts': [{'name': 'Sudath Samaraweera, MBBS MSc MD', 'role': 'CONTACT', 'email': 'sudath.samara@gmail.com', 'phone': '+94777903407'}], 'overallOfficials': [{'name': 'Sudath Samaraweera, MBBS MSc MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Research & Development Sri Lanka'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Research & Development Sri Lanka', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Psychiatry, London', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Sudath Samaraweera, Principal Investigator', 'oldOrganization': 'Institute for Research & Development'}}}}