Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1 (BBTIMV1)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00679406
First received: May 14, 2008
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention
Chronic Insomnia
Behavioral: Brief Behavioral Treatment for Insomnia

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Insomnia in Military Veterans:Phase 1

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Pittsburgh Sleep Diary [ Time Frame: Weekly during entire participation ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
  • PSQI Addendum for PTSD (PSQIA) [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
  • Sleep quality defined by:PIRS 20 and the ISI [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptom severity as measured by the CAPS [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Depression: BDI [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
  • Anxiety: BAI [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
  • Medical History: MHQ, MEDHIST_2WK, MOS [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
  • Trauma History: THQ,CES,PCL-C,ICG [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
  • Post Sleep Self Report: PSEQ-SV and POST [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • Sleepiness: EPWORTH, BASS [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
  • Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Brief Behavioral Treatment for Insomnia
Behavioral: Brief Behavioral Treatment for Insomnia
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.
Other Name: BBTI

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age is 18 and older.
  2. Military returnees from OIF/OEF
  3. Meet diagnostic criteria for chronic insomnia as defined by:

    • 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;
    • b. Frequency of insomnia complaint >3 times per week;
    • c. Duration of insomnia complaint >1 month
    • d. Associated with at least one daytime consequences
  4. 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)
  5. 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)

Exclusion Criteria:

  1. Active duty personnel, or reservists/national guards scheduled for re-deployment over the following eight months
  2. Untreated, current, and severe PTSD as determined on the SCID.
  3. 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
  4. Psychotic or bipolar disorder
  5. Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
  6. Unstable medical condition
  7. Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
  8. Seizure disorder or traumatic brain injury.
  9. 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.
  10. Sleep apnea revealed during the screening sleep study.
  11. Pregnancy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00679406

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Anne Germain, PhD. University of Pittsburgh, Department of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: Anne Germain, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00679406     History of Changes
Other Study ID Numbers: PRO07110063, NIMH: 1 R34 MH080696
Study First Received: May 14, 2008
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Chronic Insomnia lasting more than 1 month

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014