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

This study has been completed.
Sponsor:
Information provided by:
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00734799
First received: August 12, 2008
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

A substantial number of US Veterans are suffering from 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 and Operation Enduring Freedom 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
PTSD
Insomnia
Behavioral: Sleep Intervention for PTSD (SIP).
Behavioral: Usual Care/Wait-List Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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:
  • Sleep Disturbance

Secondary Outcome Measures:
  • Nightmare Frequency and Severity

Estimated Enrollment: 40
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
Behavioral: Usual Care/Wait-List Control
Patients referred to the PTSD clinic are evaluated by staff for PTSD symptomatology and severity. Based upon severity and the patient's ability to attend groups conducted at the Durham VA or at Community-Based Outpatient Centers, they are offered the opportunity to participate in one of several treatment groups. The first line of treatment facilitates PTSD symptom management and includes groups such as relaxation, anger management, and relational skills. Patients who have completed these groups, and are considered by mental health professionals to be appropriate for more intensive groups, will be referred for trauma-focused interventions if interested. Participants randomized to this condition will be offered PTSD-Sleep treatment at study completion.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be recruited from the population of OIF/OEF Veterans referred to the PTSD clinic for evaluation and treatment, and volunteers participating in the MIRREC 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 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734799

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
  More Information

No publications provided

Responsible Party: Christi S. Ulmer, Ph.D., Clinical Research Psychologist, Durham VAMC
ClinicalTrials.gov Identifier: NCT00734799     History of Changes
Other Study ID Numbers: IMR01252
Study First Received: August 12, 2008
Last Updated: March 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Durham VA Medical Center:
PTSD,
Insomnia,
Imagery Rehearsal Therapy,
IRT,
CBT for Insomnia,
CBTI.

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014