Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT01314612|
Recruitment Status : Unknown
Verified March 2011 by Michael Debakey Veterans Affairs Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : March 14, 2011
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Nightmares Posttraumatic Stress Disorder||Behavioral: Cognitive-Behavioral Insomnia and Nightmare Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
Experimental: Group Intervention
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
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.
No Intervention: Treatment as Usual
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
- Pittsburgh Sleep Quality Index, with Addendum for PTSD [ Time Frame: baseline and 20 weeks ]Self report measure of sleep quality and degree to which sleep is affected by PTSD.
- Nightmare Effects Survey [ Time Frame: baseline and 20 weeks ]Self-report assessment of psychosocial impairment resulting from experience of nightmares
- Posttraumatic Stress Disorder Checklist- Stressor Specific Version [ Time Frame: baseline and 20 weeks ]Self-report measure of Posttraumatic Stress Disorder symptoms.
- Clinician Administered PTSD Scale [ Time Frame: baseline and 10 weeks ]Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314612
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert D Beck, Ph.D||Michael E. DeBakey VA Medical Center|
|Principal Investigator:||Whitney L Brown, Psy.D||Michael E. DeBakey VA Medical Center|