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

U

United States Department of Veterans Affairs

Status

Unknown

Conditions

Posttraumatic Stress Disorder
Nightmares
Insomnia

Treatments

Behavioral: Cognitive-Behavioral Insomnia and Nightmare Group

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01314612
H-28115

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Group Intervention
Experimental group
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.
Treatment:
Behavioral: Cognitive-Behavioral Insomnia and Nightmare Group
Treatment as Usual
No Intervention group
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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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