Status:
COMPLETED
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 hea...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00840255
Start Date
April 1 2009
End Date
April 1 2012
Last Update
June 18 2012
Active Locations (1)
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1
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15237