Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1 - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institute of Mental Health (NIMH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00679406

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Insomnia in Military Veterans:Phase 1

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Pittsburgh Sleep Diary [ Time Frame: Weekly during entire participation ] [ Designated as safety issue: No ]
Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
PSQI Addendum for PTSD (PSQIA) [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Sleep quality defined by:PIRS 20 and the ISI [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PTSD symptom severity as measured by the CAPS [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
Depression: BDI [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Anxiety: BAI [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Medical History: MHQ, MEDHIST_2WK, MOS [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
Trauma History: THQ,CES,PCL-C,ICG [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
Post Sleep Self Report: PSEQ-SV and POST [ Time Frame: Screening ] [ Designated as safety issue: No ]
Sleepiness: EPWORTH, BASS [ Time Frame: Screening, Baseline, and Post Intervention ] [ Designated as safety issue: No ]
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679406

Contacts

Contact: Ryan P Stocker, B.S.	412-586-9421	stockerr@upmc.edu
Contact: Abdul N Hakim, MSW	412-246-6409	hakiman@upmc.edu

Locations

United States, Pennsylvania
Western Psychiatric Institute and Clinic	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Anne Germain, PhD
Sub-Investigator: Daniel J Buysse, MD
Sub-Investigator: Ellen Frank, PhD
Sub-Investigator: Martica Hall, PhD
Sub-Investigator: Douglas Moul, MD
Sub-Investigator: Gretchen Haas, PhD
Sub-Investigator: Abdul N Hakim, MSW
Sub-Investigator: Robin Richardson, LCSW
Sub-Investigator: Ryan P Stocker, BS
Sub-Investigator: Colleen M Walsh, BS

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

Sleep Studies for Military Veterans This link exits the ClinicalTrials.gov site

Responsible Party:	University of Pittsburgh ( Anne Germain, PhD. )
Study ID Numbers:	PRO07110063, NIMH: 1 R34 MH080696
Study First Received:	May 14, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00679406
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Chronic Insomnia lasting more than 1 month

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009