Clinical trial NCT00734799: Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Official title: Treating Co-Morbid Sleep Difficulties in Veterans With PTSD: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Insomnia
Keywords: Posttraumatic Stress Disorder
Insomnia,
Imagery Rehearsal Therapy,
IRT,
Cognitive Behavioral Therapy for Insomnia,
CBTI.
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2008-08-14
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity
timeFrame: 12-weeks after Baseline
Secondary outcomes:
measure: Nightmare Frequency
timeFrame: 12 weeks after Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christi S Ulmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.