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

March 16, 2011 updated by: Michael E. DeBakey VA Medical Center

An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index, with Addendum for PTSD
Time Frame: baseline and 20 weeks
Self report measure of sleep quality and degree to which sleep is affected by PTSD.
baseline and 20 weeks
Nightmare Effects Survey
Time Frame: baseline and 20 weeks
Self-report assessment of psychosocial impairment resulting from experience of nightmares
baseline and 20 weeks
Posttraumatic Stress Disorder Checklist- Stressor Specific Version
Time Frame: baseline and 20 weeks
Self-report measure of Posttraumatic Stress Disorder symptoms.
baseline and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale
Time Frame: baseline and 10 weeks
Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder
baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 16, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-28115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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