Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

NCT ID: NCT00679406

Last Updated: 2012-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-04-30

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).

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.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Brief Behavioral Treatment for Insomnia

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Insomnia

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BBTI

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Anne Germain

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Germain, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, Department of Psychiatry

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

NIMH: 1 R34 MH080696

Identifier Type: -

Identifier Source: secondary_id

PRO07110063

Identifier Type: -

Identifier Source: org_study_id