Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
Condition: Post-Traumatic Stress Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will test the effectiveness of cognitive behavioral therapy for insomnia in
      treating sleep disturbances in people with post-traumatic stress disorder.
    

Detailed description: 
      Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary
      insomnia but has been successfully used to treat insomnia in people with other disorders.
      Insomnia is the most commonly reported complaint of patients receiving treatment for
      post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in
      people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective
      in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in
      people with PTSD.

      Participation in this study will last 10 months. At study entry, participants will complete a
      series of eligibility assessments, including a clinical interview, a medical screening, a
      urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week,
      participants will complete baseline assessments of sleep behaviors. The assessments will
      include the following: filling out a set of questionnaires about health, mood, sleeping
      patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record
      time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like
      device, called an Actigraph, that records activity level during wakefulness and sleep;
      completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant
      (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter,
      1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep
      recorder connected to one's head to measure different stages of sleep.

      After the week of sleep assessments, participants will be randomly assigned to one of two
      groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete
      eight weekly therapy sessions targeted at improving quality of sleep and resolving problems
      with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I
      treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a
      sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a
      questionnaire booklet with similar questions to those completed in the eligibility screening.
      After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They
      will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep
      problems. After the second set of sleep assessments, the waitlist group will be offered
      CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These
      follow-up assessments will involve repeating both the sleep assessments and the clinical
      interview performed after the 8-week intervention.
    

Intervention name(s): Cognitive Behavioral Treatment for Insomnia (CBT-I)
Intervention type(s): Other
Intervention description(s): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Insomnia Disorder; Insomnia; CBT