Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

Not Applicable

Completed

Conditions: Posttraumatic Stress Disorder
Insomnia

Interventions: Behavioral: Sleep Intervention for PTSD (SIP).

Registration Number: NCT00734799

Lead Sponsor: Durham VA Medical Center

Brief Summary: A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD) following deployment in recent military conflicts, and sleep disturbance is a primary complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more self-reported and physician-rated health problems, and health status is associated with PTSD symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep disturbance. Even after receiving treatment for PTSD, Veterans continue to experience residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission.

There are currently no PTSD-specific sleep interventions available, excepting an intervention that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number of post-deployment Veterans with trauma-related sleep difficulties, such interventions are desperately needed. In this study, we will test the effectiveness of a multi-component cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The secondary objective is to examine the relative impact of the intervention on PTSD symptoms. The project is a prospective, randomized, clinical intervention trial. Participants will be randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD + Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep intervention plus usual care will produce greater improvements (reduced total wake time, increased sleep efficiency, etc) in subjective sleep measures than will Usual Care alone; 2) Veterans receiving the sleep intervention plus usual care will produce greater improvements in nightmare frequency and severity than will Usual Care alone; and 3) the relationship between PTSD symptoms and treatment group will be significantly related to sleep quality in the period intervening baseline and follow-up.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

Inclusion Criteria

Participants will be recruited from the population of Operation Iraqi Freedom/Operation Enduring Freedom veterans referred to the Posttraumatic Stress Disorder (PTSD) clinic for evaluation and treatment, and volunteers participating in the Mental Illness Research, Education and Clinical Centers (MIRECC) registry who agreed to be recontacted for future studies. All study participants will have: 1) provided informed consent; 2) utilize Durham VA Medical Center health care services as their primary source of health care; 3) will meet the Diagnostic and Statistical Manual (DSM-IV-R) criteria for a diagnosis of PTSD; 4) will screen positive for an Insomnia Disorder on the Duke Structured Sleep Interview for Sleep Disorders (DSISD); 5) and will score greater than 14 on the Insomnia Severity Index (ISI).

Exclusion Criteria

Patients who screen positive on the DSISD for symptoms of Sleep Apnea, Narcolepsy, Restless Legs Syndrome or Circadian Disorders will be excluded from the study. Participants with active drug or alcohol abuse or dependence will be excluded as well.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sleep Intervention for PTSD (SIP).	Sleep Intervention for PTSD (SIP)

Primary Outcome Measures

Name	Time	Method
Insomnia Severity	12-weeks after Baseline	Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.

Secondary Outcome Measures

Name	Time	Method
Nightmare Frequency	12 weeks after Baseline	Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.