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

This study has been completed.
Information provided by (Responsible Party):
Christi Ulmer, Durham VA Medical Center Identifier:
First received: August 12, 2008
Last updated: August 11, 2015
Last verified: August 2015

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.

Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Sleep Intervention for PTSD (SIP).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Co-Morbid Sleep Difficulties in Veterans With PTSD: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • Insomnia Severity [ Time Frame: 12-weeks after Baseline ] [ Designated as safety issue: No ]
    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:
  • Nightmare Frequency [ Time Frame: 12 weeks after Baseline ] [ Designated as safety issue: No ]
    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.

Enrollment: 22
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Usual Care/Wait-List Control
Experimental: 1
Sleep Intervention for PTSD (SIP)
Behavioral: Sleep Intervention for PTSD (SIP).
Patients in the SIP condition will receive the same elements as the Usual Care patients. In addition, these patients will receive six, bi-weekly, 1-hour individual sessions with the PI, including 3 sessions of Cognitive-Behavioral Therapy for Insomnia (CBT-I) and 3 sessions of Imagery Rehearsal Therapy (IRT). CBT-I consists of education designed to correct unrealistic sleep expectations, a prescription for an individually-tailored behavioral regimen, standard sleep hygiene recommendations, and the identification and restructuring of dysfunctional beliefs and attitudes regarding sleep. IRT is a brief intervention designed to facilitate the patient's "rescripting" of reoccurring nightmares to decrease their associated affective distress.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00734799

United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Principal Investigator: Christi S Ulmer, PhD Durham VAMC
  More Information

Responsible Party: Christi Ulmer, Clinical Research Psychologist, Durham VA Medical Center Identifier: NCT00734799     History of Changes
Other Study ID Numbers: IMR01252
Study First Received: August 12, 2008
Results First Received: February 3, 2014
Last Updated: August 11, 2015
Health Authority: United States: Federal Government

Keywords provided by Durham VA Medical Center:
Posttraumatic Stress Disorder
Imagery Rehearsal Therapy,
Cognitive Behavioral Therapy for Insomnia,

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders processed this record on November 27, 2015