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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01314612
• Other study ID #: H-28115
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 9, 2011
• Last updated: March 16, 2011
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Nightmares
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Nightmare Effects Survey	Self-report assessment of psychosocial impairment resulting from experience of nightmares	baseline and 20 weeks	No
Primary	Posttraumatic Stress Disorder Checklist- Stressor Specific Version	Self-report measure of Posttraumatic Stress Disorder symptoms.	baseline and 20 weeks	No
Secondary	Clinician Administered PTSD Scale	Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder	baseline and 10 weeks	No