Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

NCT00679406 | Completed DMC

• 2 other identifiers: PRO07110063NIMH: 1 R34 MH080696
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia lasting more than 1 month

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (1)

1

EXPERIMENTAL

Brief Behavioral Treatment for Insomnia

Behavioral: Brief Behavioral Treatment for Insomnia

Interventions

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.

Also known as: BBTI

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Anne Germain, PhD.

  University of Pittsburgh, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (1)