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

NCT01314612 | Unknown DMC

• 1 other identifier: H-28115
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Nightmares; Posttraumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality Index, with Addendum for PTSD

  Self report measure of sleep quality and degree to which sleep is affected by PTSD.

  baseline and 20 weeks

• Nightmare Effects Survey

  Self-report assessment of psychosocial impairment resulting from experience of nightmares

  baseline and 20 weeks

• Posttraumatic Stress Disorder Checklist- Stressor Specific Version

  Self-report measure of Posttraumatic Stress Disorder symptoms.

  baseline and 20 weeks

Secondary Outcomes (1)

• Clinician Administered PTSD Scale

  baseline and 10 weeks

Study Arms (2)

Group Intervention

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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

Interventions

Cognitive-Behavioral Insomnia and Nightmare Group BEHAVIORAL

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.

Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Robert D Beck, Ph.D

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

• Whitney L Brown, Psy.D

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 17, 2011

Record last verified: 2011-03

Locations

US (1)