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

Primary Purpose

Insomnia, Nightmares, Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Insomnia and Nightmare Group
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, group psychotherapy, nightmares, PTSD, posttraumatic stress disorder, Veterans, cognitive-behavioral intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Intervention

Treatment as Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinician Administered PTSD Scale
Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder

Full Information

First Posted
March 9, 2011
Last Updated
March 16, 2011
Sponsor
Michael E. DeBakey VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01314612
Brief Title
Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)
Official Title
An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Michael E. DeBakey VA Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Nightmares, Posttraumatic Stress Disorder
Keywords
Insomnia, group psychotherapy, nightmares, PTSD, posttraumatic stress disorder, Veterans, cognitive-behavioral intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Insomnia and Nightmare Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index, with Addendum for PTSD
Description
Self report measure of sleep quality and degree to which sleep is affected by PTSD.
Time Frame
baseline and 20 weeks
Title
Nightmare Effects Survey
Description
Self-report assessment of psychosocial impairment resulting from experience of nightmares
Time Frame
baseline and 20 weeks
Title
Posttraumatic Stress Disorder Checklist- Stressor Specific Version
Description
Self-report measure of Posttraumatic Stress Disorder symptoms.
Time Frame
baseline and 20 weeks
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Description
Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder
Time Frame
baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Beck, Ph.D
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Whitney L Brown, Psy.D
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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