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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Brief Behavioral Treatment for Insomnia

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Western Psychiatric Institute and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: BBTI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Anne Germain, PhD., University of Pittsburgh, Department of Psychiatry

Publications and helpful links

Helpful Links

• Sleep Studies for Military Veterans

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): June 18, 2012
• Last Update Submitted That Met QC Criteria: June 15, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Insomnia lasting more than 1 month
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: PRO07110063; NIMH: 1 R34 MH080696