Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)
Completed · Not applicable
Conditions studied: Chronic Insomnia
In brief
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.
Key facts
- Study ID
- NCT00840255
- Run by
- University of Pittsburgh
- People needed
- 40
- Starts
- 2009-04-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2012-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Western Psychiatric Institute & Clinic — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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