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

NCT00840255 | Completed DMC

• 2 other identifiers: PRO08070327NIMH: 1 R34 MH080696
• Study Type: interventional
• Target: 40
• 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), finalizing a treatment manual.

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia lasting more than 1 month

Outcome Measures

Primary Outcomes (4)

• Pittsburgh Sleep Diary

  Weekly

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline and Post Intervention

• PSQI Addendum for PTSD (PSQIA)

  Baseline and Post

• Sleep Quality defined by: PIRS-20 and ISI

  Screening,Baseline, and Post

Secondary Outcomes (9)

• PTSD symptom severity as measured by the CAPS

  Screening

• Depression: BDI

  Baseline and Post

• Anxiety: BAI

  Baseline and Post

• Medical History: MHQ, MEDHIST_2WK, MOS

  Screening, Baseline, and Post

• Trauma History: THQ,CES,PCL-C,ICG

  Screening, Baseline, and Post

Study Arms (2)

Breif Behavioral Treatment of Insomnia

ACTIVE COMPARATOR

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.

Behavioral: BBTI-MV

Information Control

OTHER

This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm.

Other: Information Control

Interventions

BBTI-MV BEHAVIORAL

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.

Breif Behavioral Treatment of Insomnia

Information Control OTHER

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

Information Control

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 years old 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
• Frequency of insomnia complaint \>3 times per week;
• Duration of insomnia complaint \>1 month
• 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 to re-deploy if their departure date is \< 2 months from the consent date
• 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 open skull 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 & Clinic

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (1)

• Germain A, Richardson R, Stocker R, Mammen O, Hall M, Bramoweth AD, Begley A, Rode N, Frank E, Haas G, Buysse DJ. Treatment for insomnia in combat-exposed OEF/OIF/OND military veterans: preliminary randomized controlled trial. Behav Res Ther. 2014 Oct;61:78-88. doi: 10.1016/j.brat.2014.07.016. Epub 2014 Aug 12.

  PMID: 25194223 DERIVED

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (1)