Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 1:10 PM
Study NCT ID:
NCT00933959
Status:
COMPLETED
Last Update Posted:
2009-07-08
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study on Sleep Management for US Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-06', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Outcomes Study-Sleep Scale', 'timeFrame': 'Pre-treatment, Week 1, Post treatment'}, {'measure': 'Medical Outcomes Study Short Form-36 for Veterans', 'timeFrame': 'Pre-treatment, Post treatment'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression Scale', 'timeFrame': 'Pre-treatment, Post treatment'}, {'measure': 'Five-factor Mindfulness Questionnaire', 'timeFrame': 'Pre-treatment, Post treatment'}, {'measure': 'PTSD Check List-Military', 'timeFrame': 'Pre-treatment, Post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep problems', 'Awareness training program', 'Mind body bridging'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).', 'detailedDescription': 'Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.\n2. On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.\n\nExclusion Criteria:\n\n1. The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.'}, 'identificationModule': {'nctId': 'NCT00933959', 'briefTitle': 'Pilot Study on Sleep Management for US Veterans', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Pilot Study of Two Contrasting Intervention Programs for Sleep Management', 'orgStudyIdInfo': {'id': '27522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mind-Body Bridging Program', 'description': 'Subjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the VASLCHCS. Each training session will comprise a number of objectives:\n\nSession 1:\n\n1. The patient will discover the underlying cause of the insomnia.\n2. The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly.\n\nSession 2:\n\n1. The patient will learn how to reduce daytime stress.\n2. The patient will experience a greater sense of self.\n\nTo be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep.', 'interventionNames': ['Behavioral: Mind-Body Bridging Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Hygiene', 'description': 'Participants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis.', 'interventionNames': ['Behavioral: Sleep Hygiene']}], 'interventions': [{'name': 'Mind-Body Bridging Program', 'type': 'BEHAVIORAL', 'otherNames': ['MBBP'], 'description': 'Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.', 'armGroupLabels': ['Mind-Body Bridging Program']}, {'name': 'Sleep Hygiene', 'type': 'BEHAVIORAL', 'otherNames': ['SH'], 'description': 'Treatment as usual', 'armGroupLabels': ['Sleep Hygiene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'SLC VA Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Gavin West, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salt Lake City VA/University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gavin West, M.D.', 'oldOrganization': 'SLC VA Medical Center/University of Utah'}}}}