Clinical trial NCT00679406: Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1
Official title: Treatment of Insomnia in Military Veterans:Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Chronic Insomnia lasting more than 1 month
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Diary
timeFrame: Weekly during entire participation
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Post Intervention
measure: PSQI Addendum for PTSD (PSQIA)
timeFrame: Baseline and Post Intervention
measure: Sleep quality defined by:PIRS 20 and the ISI
timeFrame: Screening, Baseline, and Post Intervention
Secondary outcomes:
measure: PTSD symptom severity as measured by the CAPS
timeFrame: Screening
measure: Depression: BDI
timeFrame: Baseline and Post Intervention
measure: Anxiety: BAI
timeFrame: Baseline and Post Intervention
measure: Medical History: MHQ, MEDHIST_2WK, MOS
timeFrame: Screening, Baseline, and Post Intervention
measure: Trauma History: THQ,CES,PCL-C,ICG
timeFrame: Screening, Baseline, and Post Intervention
measure: Post Sleep Self Report: PSEQ-SV and POST
timeFrame: Screening
measure: Sleepiness: EPWORTH, BASS
timeFrame: Screening, Baseline, and Post Intervention
measure: Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
timeFrame: Baseline and Post Intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Department of Psychiatry
name: Anne Germain, PhD.
role: PRINCIPAL_INVESTIGATOR
References: