Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress
Completed · Not applicable
Conditions studied: Stress Disorders, Post-Traumatic, Depression, Sleep
In brief
The primary purpose of this study is to test whether and how cognitive-behavioral therapy for insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms. The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to assess the role of neurobiological processes and sleep architecture in mediating treatment outcomes.
Key facts
- Study ID
- NCT01743339
- Run by
- University of Rochester
- People needed
- 110
- Starts
- 2013-01-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-04-27
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- must be English-speaking
- age 18-64 years old
- with exposure to trauma from interpersonal violence in the past year
- meet diagnostic criteria for full or subthreshold PTSD
- meet diagnostic criteria for MDD
- meet criteria for Insomnia Disorder
You may not qualify if…
- untreated sleep disorders other than insomnia or nightmares
- dementia or cognitive impairment
- history of schizophrenia or bipolar I disorder
- current suicidality
- health conditions with immunological components or taking immunosuppressive therapies
- active alcohol dependence
- medication use including antipsychotics, opiate analgesics, and sleep medications
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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