Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive an 8-week course of cognitive behavioral therapy for insomnia.

Group Type EXPERIMENTAL

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Intervention Type OTHER

CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep

2

Participants will be placed on a waitlist for 8 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Treatment for Insomnia (CBT-I)

CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic PTSD for at least 3 months
* Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
* Persistent residual insomnia