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

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ClinicalTrials.gov Identifier: NCT00734799
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Christi Ulmer, Durham VA Medical Center

August 12, 2008
August 14, 2008
February 3, 2014
September 7, 2015
September 7, 2015
January 2008
December 2009   (Final data collection date for primary outcome measure)
Insomnia Severity [ Time Frame: 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.
Sleep Disturbance
Complete list of historical versions of study NCT00734799 on ClinicalTrials.gov Archive Site
Nightmare Frequency [ Time Frame: 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.
Nightmare Frequency and Severity
Not Provided
Not Provided
 
Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Treating Co-Morbid Sleep Difficulties in Veterans With PTSD: A Pilot Study

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Insomnia
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.
  • No Intervention: 2
    Usual Care/Wait-List Control
  • Experimental: 1
    Sleep Intervention for PTSD (SIP)
    Intervention: Behavioral: Sleep Intervention for PTSD (SIP).
Ulmer CS, Edinger JD, Calhoun PS. A multi-component cognitive-behavioral intervention for sleep disturbance in veterans with PTSD: a pilot study. J Clin Sleep Med. 2011 Feb 15;7(1):57-68.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
40
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00734799
IMR01252
No
Not Provided
Not Provided
Christi Ulmer, Durham VA Medical Center
Durham VA Medical Center
Not Provided
Principal Investigator: Christi S Ulmer, PhD Durham VAMC
Durham VA Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP