Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)

Chronic Insomnia Clinical Trial

— BBTIMVII  

Official title:

Treatment of Insomnia in Military Veterans:Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840255
• Other study ID #: PRO08070327
• Secondary ID: NIMH: 1 R34 MH08
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: June 15, 2012
• Start date: April 2009
• Est. completion date: April 2012

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), finalizing a treatment manual.

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 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. The specific aims of Phase II are: (1) To explore the effects of BBTI-MV on sleep and daytime symptoms of psychiatric distress. We anticipate that participants randomized to BBTI-MV will show a higher categorical response rate and remission for sleep symptoms than subjects randomized to IC. (2) To evaluate in a preliminary manner the durability of therapeutic gains and by conducting a naturalistic follow-up assessment six months post-treatment in responders. (3) To explore whether the nature of combat-related experiences, time since deployment and since, return to the US, deployment theater, medication use and change in dosage, mood and anxiety or disorders affect sleep treatment adherence and outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age is 18 years old 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

• Frequency of insomnia complaint >3 times per week;

• Duration of insomnia complaint >1 month

• 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 to re-deploy if their departure date is < 2 months from the consent date

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 open skull 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia

Intervention

Behavioral:
• BBTI-MV
Twenty participants will be randomized to BBTI-MV. As previously described, the intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3, and telephone appointments on Weeks 2 and 4. Interventions will be delivered at Western Psychiatric Institutes and Clinic. If possible, (according to space availability), the face-to-face sessions may also be conducted at the VAPHS clinics or at Reserve and Veterans Centers locally and regionally to strengthen our relations with local care and services providers and centers, and to facilitate future collaborative efforts. The duration of the first treatment visit is 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.

Other:
• Information Control
Participants will receive two brochures from the American Academy on Sleep Medicine of Sleep Hygiene and on Insomnia. The therapists will read the content of the 2 brochures with participants, and discuss how the information provide relates to individual participants' sleep experiences. No recommendations for altering sleep schedules will be made by the assigned therapist. Participants will be instructed to read these two brochures over the course of the following week, and to consider how the information provided in the brochures related to their own sleep patterns

Locations

Country	Name	City	State
United States	Western Psychiatric Institute & 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	No
Primary	Pittsburgh Sleep Quality Index (PSQI)		Baseline and Post Intervention	No
Primary	PSQI Addendum for PTSD (PSQIA)		Baseline and Post	No
Primary	Sleep Quality defined by: PIRS-20 and ISI		Screening,Baseline, and Post	No
Secondary	PTSD symptom severity as measured by the CAPS		Screening	Yes
Secondary	Depression: BDI		Baseline and Post	No
Secondary	Anxiety: BAI		Baseline and Post	No
Secondary	Medical History: MHQ, MEDHIST_2WK, MOS		Screening, Baseline, and Post	No
Secondary	Trauma History: THQ,CES,PCL-C,ICG		Screening, Baseline, and Post	No
Secondary	Post Sleep Self Report: PSEQ-SV and POST		Screening	No
Secondary	Sleepiness: EPWORTH, BASS		Screening, Baseline, and Post	No
Secondary	Mood and Behavior: BIS/BAS, SMITH, PANAS		Screening, Baseline, and Post	No
Secondary	Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey		Baseline and Post	No

External Links

•   Pittsburgh Veterans Sleep Studies