Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01314612
Enrollment
30
Registered
2011-03-14
Start date
2011-03-31
Completion date
2011-08-31
Last updated
2011-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Nightmares, Posttraumatic Stress Disorder

Keywords

Insomnia, group psychotherapy, nightmares, PTSD, posttraumatic stress disorder, Veterans, cognitive-behavioral intervention

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.

Interventions

BEHAVIORALCognitive-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.

Sponsors

Michael E. DeBakey VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nightmare Effects Surveybaseline and 20 weeksSelf-report assessment of psychosocial impairment resulting from experience of nightmares
Posttraumatic Stress Disorder Checklist- Stressor Specific Versionbaseline and 20 weeksSelf-report measure of Posttraumatic Stress Disorder symptoms.
Pittsburgh Sleep Quality Index, with Addendum for PTSDbaseline and 20 weeksSelf report measure of sleep quality and degree to which sleep is affected by PTSD.

Secondary

MeasureTime frameDescription
Clinician Administered PTSD Scalebaseline and 10 weeksStructured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026