We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679406
First Posted: May 16, 2008
Last Update Posted: June 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Insomnia in Military Veterans:Phase 1

Further study details as provided by Anne Germain, University of Pittsburgh:

Primary Outcome Measures:
  • Pittsburgh Sleep Diary [ Time Frame: Weekly during entire participation ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and Post Intervention ]
  • PSQI Addendum for PTSD (PSQIA) [ Time Frame: Baseline and Post Intervention ]
  • Sleep quality defined by:PIRS 20 and the ISI [ Time Frame: Screening, Baseline, and Post Intervention ]

Secondary Outcome Measures:
  • PTSD symptom severity as measured by the CAPS [ Time Frame: Screening ]
  • Depression: BDI [ Time Frame: Baseline and Post Intervention ]
  • Anxiety: BAI [ Time Frame: Baseline and Post Intervention ]
  • Medical History: MHQ, MEDHIST_2WK, MOS [ Time Frame: Screening, Baseline, and Post Intervention ]
  • Trauma History: THQ,CES,PCL-C,ICG [ Time Frame: Screening, Baseline, and Post Intervention ]
  • Post Sleep Self Report: PSEQ-SV and POST [ Time Frame: Screening ]
  • Sleepiness: EPWORTH, BASS [ Time Frame: Screening, Baseline, and Post Intervention ]
  • Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey [ Time Frame: Baseline and Post Intervention ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679406


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

Additional Information:
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
First Submitted: May 14, 2008
First Posted: May 16, 2008
Last Update Posted: June 18, 2012
Last Verified: June 2012

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

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