Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT00679406
Status:
COMPLETED
Last Update Posted:
2012-06-18
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-15', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-15', 'lastUpdatePostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Diary', 'timeFrame': 'Weekly during entire participation'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline and Post Intervention'}, {'measure': 'PSQI Addendum for PTSD (PSQIA)', 'timeFrame': 'Baseline and Post Intervention'}, {'measure': 'Sleep quality defined by:PIRS 20 and the ISI', 'timeFrame': 'Screening, Baseline, and Post Intervention'}], 'secondaryOutcomes': [{'measure': 'PTSD symptom severity as measured by the CAPS', 'timeFrame': 'Screening'}, {'measure': 'Depression: BDI', 'timeFrame': 'Baseline and Post Intervention'}, {'measure': 'Anxiety: BAI', 'timeFrame': 'Baseline and Post Intervention'}, {'measure': 'Medical History: MHQ, MEDHIST_2WK, MOS', 'timeFrame': 'Screening, Baseline, and Post Intervention'}, {'measure': 'Trauma History: THQ,CES,PCL-C,ICG', 'timeFrame': 'Screening, Baseline, and Post Intervention'}, {'measure': 'Post Sleep Self Report: PSEQ-SV and POST', 'timeFrame': 'Screening'}, {'measure': 'Sleepiness: EPWORTH, BASS', 'timeFrame': 'Screening, Baseline, and Post Intervention'}, {'measure': 'Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey', 'timeFrame': 'Baseline and Post Intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Insomnia lasting more than 1 month'], 'conditions': ['Chronic Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting \\>1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).', 'detailedDescription': 'Insomnia is one of the most common reasons for referral to mental health services in active duty personnel. Chronic insomnia often persists post-deployment, contributes to poor mental and physical health outcomes, and requires targeted interventions. Effective behavioral treatments of insomnia have not been adapted and tested for the treatment of chronic insomnia comorbid to combat-related mental disorders and stress reactions. In addition, effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal of this R34 Exploratory Clinical Research Grant is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting \\>1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions. We call this intervention the Brief Behavioral Treatment of Insomnia for Military Veterans (BBTI-MV). The proposed study includes two phases. Phase I aims at iteratively adapting and refining a treatment manual for insomnia in OIF/OEF military returnees. Outcomes of interest include self-report, diary, and actigraphic sleep measures, as well as measures of PTSD, anxiety, and depression, and perceived physical health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age is 18 and older.\n2. Military returnees from OIF/OEF\n3. Meet diagnostic criteria for chronic insomnia as defined by:\n\n * a. Complaint of sleep latency \\>30 minutes, or wake time after sleep onset \\>30 minutes, or Sleep Efficiency \\<85%, or a complaint of non-restorative sleep;\n * b. Frequency of insomnia complaint \\>3 times per week;\n * c. Duration of insomnia complaint \\>1 month\n * d. Associated with at least one daytime consequences\n4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)\n5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)\n\nExclusion Criteria:\n\n1. Active duty personnel, or reservists/national guards scheduled for re-deployment over the following eight months\n2. Untreated, current, and severe PTSD as determined on the SCID.\n3. Untreated, current, and severe Major Depressive Disorder as determined by the Structured Clinical Interview for DSM-IV and a score \\> 30 on the Beck Depression Inventory\n4. Psychotic or bipolar disorder\n5. Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results\n6. Unstable medical condition\n7. Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration\n8. Seizure disorder or traumatic brain injury.\n9. Current sleep disorders such as nightmare disorder, restless legs syndrome, or suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements.\n10. Sleep apnea revealed during the screening sleep study.\n11. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT00679406', 'acronym': 'BBTIMV1', 'briefTitle': 'Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Treatment of Insomnia in Military Veterans:Phase 1', 'orgStudyIdInfo': {'id': 'PRO07110063'}, 'secondaryIdInfos': [{'id': 'NIMH: 1 R34 MH080696'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Brief Behavioral Treatment for Insomnia', 'interventionNames': ['Behavioral: Brief Behavioral Treatment for Insomnia']}], 'interventions': [{'name': 'Brief Behavioral Treatment for Insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['BBTI'], 'description': 'Effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting \\>1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Anne Germain, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh, Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anne Germain', 'investigatorAffiliation': 'University of Pittsburgh'}}}}