Skip to main content
OpenTrials
Completed

NCT Number: NCT00679406

Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age is 18 and older.
  • Military returnees from OIF/OEF
  • 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
  • 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)
  • 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

  • Active duty personnel, or reservists/national guards scheduled for re-deployment over the following eight months
  • Untreated, current, and severe PTSD as determined on the SCID.
  • 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
  • Psychotic or bipolar disorder
  • Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
  • Unstable medical condition
  • Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
  • Seizure disorder or traumatic brain injury.
  • 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.
  • Sleep apnea revealed during the screening sleep study.
  • Pregnancy.

Treatment and study plan

Brief Behavioral Treatment for Insomnia

Behavioral

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 names: BBTI

Primary outcomes

  1. Pittsburgh Sleep Diary

    Time frame: Weekly during entire participation

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Post Intervention

  3. PSQI Addendum for PTSD (PSQIA)

    Time frame: Baseline and Post Intervention

  4. Sleep quality defined by:PIRS 20 and the ISI

    Time frame: Screening, Baseline, and Post Intervention

Secondary outcomes

  1. PTSD symptom severity as measured by the CAPS

    Time frame: Screening

  2. Depression: BDI

    Time frame: Baseline and Post Intervention

  3. Anxiety: BAI

    Time frame: Baseline and Post Intervention

  4. Medical History: MHQ, MEDHIST_2WK, MOS

    Time frame: Screening, Baseline, and Post Intervention

  5. Trauma History: THQ,CES,PCL-C,ICG

    Time frame: Screening, Baseline, and Post Intervention

  6. Post Sleep Self Report: PSEQ-SV and POST

    Time frame: Screening

  7. Sleepiness: EPWORTH, BASS

    Time frame: Screening, Baseline, and Post Intervention

  8. Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey

    Time frame: Baseline and Post Intervention

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment of Insomnia in Military Veterans:Phase 1

Acronym: BBTIMV1

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 16, 2008
Registry last updated
Jun 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.