Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01314612
First received: March 9, 2011
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder that develops after an extremely stressful event or events. PTSD is associated with problems falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments that do not involve taking medication have been shown to help improve problems related to sleep and nightmares. However, very few of these treatments address both sleep problems and nightmares at the same time, even though many people suffer from both problems. The purpose of this study is to examine the effectiveness of a combined treatment for sleep problems and nightmares in Veterans suffering from combat-related PTSD that is presented in a group format. The investigators hypothesize that the completion of this treatment will lead to increases in sleep quality and decreases in the frequency and severity of nightmares as measured by standard questionnaires.


Condition Intervention
Insomnia
Nightmares
Posttraumatic Stress Disorder
Behavioral: Cognitive-Behavioral Insomnia and Nightmare Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index, with Addendum for PTSD [ Time Frame: baseline and 20 weeks ] [ Designated as safety issue: No ]
    Self report measure of sleep quality and degree to which sleep is affected by PTSD.

  • Nightmare Effects Survey [ Time Frame: baseline and 20 weeks ] [ Designated as safety issue: No ]
    Self-report assessment of psychosocial impairment resulting from experience of nightmares

  • Posttraumatic Stress Disorder Checklist- Stressor Specific Version [ Time Frame: baseline and 20 weeks ] [ Designated as safety issue: No ]
    Self-report measure of Posttraumatic Stress Disorder symptoms.


Secondary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
    Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Intervention
Subjects randomly assigned to this arm of the study will receive the 9-week insomnia and nightmare intervention group once per week for 90 minutes in addition to continuing treatment as usual with medical and mental health providers.
Behavioral: Cognitive-Behavioral Insomnia and Nightmare Group
Group based cognitive-behavioral therapy meeting weekly for 90 minutes over the course of 9 weeks. Utilizes stimulus control, sleep scheduling, and progressive muscle relaxation to address symptoms of insomnia. Imagery rehearsal and rescripting are used to address nightmare symptoms.
No Intervention: Treatment as Usual
This group is randomly assigned to receive only treatment as usual and does not receive the active intervention of the insomnia and nightmare group treatment. This treatment will be made available to these members once the study is completed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be enrolled in the Michael E. DeBakey VAMC Trauma Recovery Program and qualify for a diagnosis of combat-related PTSD related to service in Vietnam-era conflicts as measured by responses to the Clinician-Administered PTSD Scale (CAPS) and total score ≥ 50 on the Posttraumatic Stress Disorder Checklist Stressor Specific Version (PCL-S)
  • Have a clinically significant sleep problem as measured by a total score > 5 on the Pittsburgh Sleep Quality Index (PSQI)
  • Have a repetitive trauma-related nightmare at least once per week on average, as measured by the Nightmare Frequency Questionnaire (NFQ), and which significantly impairs sleep as measured by response ≥ 2 on question 1a of the Nightmare Effects Survey (NES)
  • Be stable on current regimen of psychotropic medication (i.e., no changes to medications and/or dosages) if applicable
  • Must sign consent to be audio-recorded as part of the course of the treatment

Exclusion Criteria:

  • Current substance dependence
  • Planned or ongoing participation in Prolonged Exposure or Cognitive Processing Therapy during treatment participation
  • Organic psychosis
  • Bipolar I disorder
  • Epilepsy
  • Currently on benzodiazepine or hypnotic medication to treat sleep
  • Currently take prazosin
  • Indication of undiagnosed sleep apnea defined as score ≥ .5 across items 1, 5, and 8 of the Multivariable Apnea Risk Index
  • Uncontrolled sleep apnea
  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: NCT01314612

Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: Robert D Beck, Ph.D Michael E. DeBakey VA Medical Center
Principal Investigator: Whitney L Brown, Psy.D Michael E. DeBakey VA Medical Center
  More Information

No publications provided

Responsible Party: Robert Beck, Ph.D, Postdoctoral Fellow, Michael E. DeBakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01314612     History of Changes
Other Study ID Numbers: H-28115
Study First Received: March 9, 2011
Last Updated: March 16, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Insomnia
group psychotherapy
nightmares
PTSD
posttraumatic stress disorder
Veterans
cognitive-behavioral intervention

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Sleep Initiation and Maintenance Disorders
Anxiety Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014