Clinical trial NCT00840255: Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)
Official title: Treatment of Insomnia in Military Veterans:Phase 2
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: 2009-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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), finalizing a treatment manual.

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 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.

Eligibility criteria: 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.

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