Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02712918
Status:
COMPLETED
Last Update Posted:
2016-03-18
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Behavioral Activation Treatment for Depression With Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of Beck's Depression Inventory-II from baseline", 'timeFrame': 'Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).'}], 'secondaryOutcomes': [{'measure': 'Credibility and Expectancies Questionnaire', 'timeFrame': 'Second day of admission. After first sessions of BATD.', 'description': 'Only BATD group'}, {'measure': 'Treatment Evaluation Inventory - Short Form', 'timeFrame': 'Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..', 'description': 'Only BATD group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Inpatient', 'Acute', 'Brief Behavioral Activation Treatment for Depression'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '11317637', 'type': 'BACKGROUND', 'citation': 'Lejuez CW, Hopko DR, Hopko SD. A brief behavioral activation treatment for depression. Treatment manual. Behav Modif. 2001 Apr;25(2):255-86. doi: 10.1177/0145445501252005.'}, {'pmid': '21324944', 'type': 'BACKGROUND', 'citation': 'Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.'}, {'pmid': '12971122', 'type': 'RESULT', 'citation': 'Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. The study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for BATD With inpatients. The current study compared BATD to Treatment as Usual in a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe depression (BDI-II \\> 28 Points).\n* Admission length of at least 3 days\n* Evaluated to benefit from depression treatment by unit psychiatrist.\n\nExclusion Criteria:\n\n* Current psychotic disorder\n* Previously diagnosis with psychotic disorder (including Bipolar disorder)'}, 'identificationModule': {'nctId': 'NCT02712918', 'briefTitle': 'Brief Behavioral Activation Treatment for Depression With Inpatients', 'organization': {'class': 'OTHER', 'fullName': 'Lovisenberg Diakonale Hospital'}, 'officialTitle': 'An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BATD_16674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Behavioral Activation Treatment for Depression', 'description': 'Behavioral treatment of depression. The study utilized the revised version of the Brief Behavioral Activation Treatment for Depression (BATD) protocol from 2011. The treatment was added to treatment as usual. Up to 10 sessions were administered.', 'interventionNames': ['Behavioral: Brief Behavioral Activation Treatment for Depression']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard care', 'description': 'Standard CARE (SC) at the inpatient unit. Mandatory: Therapeutic conversations with psychiatrist, psychologist or M.D, milieu therapy. Optional: Psychosomatic physiotherapy, therapeutic groups, psychopharmacological treatment.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Brief Behavioral Activation Treatment for Depression', 'type': 'BEHAVIORAL', 'description': 'Behavioral treatment of depression which focuses on increasing the Level of positive reinforcement through systematic and goal directed activation of behavior. Goal and values are assessed and used to determine target behaviors.', 'armGroupLabels': ['Brief Behavioral Activation Treatment for Depression']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Treatment as usual at the ward', 'armGroupLabels': ['Standard care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lovisenberg Diakonale Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo Metropolitan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Learning Disability Nurse/MSc Behavior Analysis', 'investigatorFullName': 'Martin Myhre', 'investigatorAffiliation': 'Lovisenberg Diakonale Hospital'}}}}