Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)

Not Applicable

Completed

• Conditions: Chronic Insomnia
• Interventions: Behavioral: BBTI-MV; Other: Information Control

• Registration Number: NCT00840255
• Lead Sponsor: University of Pittsburgh

Brief Summary

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), finalizing a treatment manual.

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 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. The specific aims of Phase II are: (1) To explore the effects of BBTI-MV on sleep and daytime symptoms of psychiatric distress. We anticipate that participants randomized to BBTI-MV will show a higher categorical response rate and remission for sleep symptoms than subjects randomized to IC. (2) To evaluate in a preliminary manner the durability of therapeutic gains and by conducting a naturalistic follow-up assessment six months post-treatment in responders. (3) To explore whether the nature of combat-related experiences, time since deployment and since, return to the US, deployment theater, medication use and change in dosage, mood and anxiety or disorders affect sleep treatment adherence and outcomes.

Study Timeline

• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Study Start: 2009-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-15
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age is 18 years old 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

   • Frequency of insomnia complaint >3 times per week;
   • Duration of insomnia complaint >1 month
   • 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 to re-deploy if their departure date is < 2 months from the consent date
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 open skull 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breif Behavioral Treatment of Insomnia	BBTI-MV	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.
Information Control	Information Control	This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm.

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Diary	Weekly
Pittsburgh Sleep Quality Index (PSQI)	Baseline and Post Intervention
PSQI Addendum for PTSD (PSQIA)	Baseline and Post
Sleep Quality defined by: PIRS-20 and ISI	Screening,Baseline, and Post

Secondary Outcome Measures

Name	Time	Method
PTSD symptom severity as measured by the CAPS	Screening
Depression: BDI	Baseline and Post
Anxiety: BAI	Baseline and Post
Medical History: MHQ, MEDHIST_2WK, MOS	Screening, Baseline, and Post
Trauma History: THQ,CES,PCL-C,ICG	Screening, Baseline, and Post
Post Sleep Self Report: PSEQ-SV and POST	Screening
Sleepiness: EPWORTH, BASS	Screening, Baseline, and Post
Mood and Behavior: BIS/BAS, SMITH, PANAS	Screening, Baseline, and Post
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey	Baseline and Post

Trial Locations

Locations (1)

Western Psychiatric Institute & Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States