Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

Chronic Insomnia Clinical Trial

— BBTIMV1  

Official title:

Treatment of Insomnia in Military Veterans:Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679406
• Other study ID #: PRO07110063
• Secondary ID: NIMH: 1 R34 MH08
• Status: Completed
• Phase: N/A
• First received: May 14, 2008
• Last updated: June 15, 2012
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: June 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia

Intervention

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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Diary		Weekly during entire participation	No
Primary	Pittsburgh Sleep Quality Index (PSQI)		Baseline and Post Intervention	No
Primary	PSQI Addendum for PTSD (PSQIA)		Baseline and Post Intervention	No
Primary	Sleep quality defined by:PIRS 20 and the ISI		Screening, Baseline, and Post Intervention	No
Secondary	PTSD symptom severity as measured by the CAPS		Screening	Yes
Secondary	Depression: BDI		Baseline and Post Intervention	No
Secondary	Anxiety: BAI		Baseline and Post Intervention	No
Secondary	Medical History: MHQ, MEDHIST_2WK, MOS		Screening, Baseline, and Post Intervention	No
Secondary	Trauma History: THQ,CES,PCL-C,ICG		Screening, Baseline, and Post Intervention	No
Secondary	Post Sleep Self Report: PSEQ-SV and POST		Screening	No
Secondary	Sleepiness: EPWORTH, BASS		Screening, Baseline, and Post Intervention	No
Secondary	Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey		Baseline and Post Intervention	No

External Links

•   Sleep Studies for Military Veterans