Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00691626
First received: June 2, 2008
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF veterans at the Philadelphia and the West Haven VA Medical Centers. Participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning veterans.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder Sleep Disorders Nightmares |
Behavioral: CBT for Insomnia plus Imagery Rehearsal Behavioral: CBT for Insomnia plus psychoeducation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | CBT for Nightmares in OEF/OIF Veterans |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pittsburgh Sleep Quality Index [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 115 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
CBT for Insomnia plus Imagery Rehearsal
|
Behavioral: CBT for Insomnia plus Imagery Rehearsal
patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress
|
|
Active Comparator: Arm 2
CBT for Insomnia
|
Behavioral: CBT for Insomnia plus psychoeducation
patients receive standard CBT for insomnia combined with psychoeducation
Other Name: Sleep and Nightmare Management
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Currently enrolled in treatment in the Philadelphia VA Medical Center or VA Connecticut Healthcare System Mental Health Clinic
- Meets DSM-IV-R criteria for current PTSD (within the past month)
- Repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6 months)
- A global sleep disturbance, as indicated by a score of five or greater on the Pittsburgh Sleep Quality Index
- Ability to read and speak English
- A concurrent anxiety disorder or depressive disorder diagnosis will be allowed
- Dementia related to head injury and amnestic disorder related to head injury will be allowed
Exclusion Criteria:
- Current substance dependence
- Bipolar disorder
- Delirium
- Dementia that is not related to head injury
- Amnestic disorder that is not related to head injury
- Schizophrenia and other psychotic disorders
- Severe traumatic brain injury, as indicated by self-report (loss of consciousness or alteration of mental status greater than 24 hours, or peri-traumatic memory loss, or any posttraumatic amnesia greater than 7 days)
- The presence of diagnosed sleep disorders other than insomnia: narcolepsy, circadian rhythm sleep disorders, and periodic limb movement disorder. Participants in treatment for sleep apnea, or who have not benefited from or declined available treatment may be included.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691626
Contacts
| Contact: Gerlinde C Harb, PhD | (215) 823-5800 ext 6128 | harb_g@mail.trc.upenn.edu |
| Contact: Richard Ross, MD PhD | (215) 823-5800 ext 4046 | Richard.Ross2@va.gov |
Locations
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Gerlinde C Harb, PhD 215-823-5800 ext 6128 harb_g@mail.trc.upenn.edu | |
| Sub-Investigator: Joan Cook, PhD | |
| Principal Investigator: Richard Ross, MD PhD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Richard Ross, MD PhD | VA Medical Center, Philadelphia |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00691626 History of Changes |
| Other Study ID Numbers: | PT074364 |
| Study First Received: | June 2, 2008 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
posttraumatic stress nightmares sleep psychotherapy imagery rehearsal |
insomnia behavioral treatment veterans Operation Iraqi Freedom Operation Enduring Freedom |
Additional relevant MeSH terms:
|
Sleep Disorders Parasomnias Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 16, 2013