Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00691626
First received: June 2, 2008
Last updated: September 29, 2014
Last verified: September 2014

June 2, 2008
September 29, 2014
April 2009
January 2015   (final data collection date for primary outcome measure)
Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]
Nightmare Frequency Questionnaire [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00691626 on ClinicalTrials.gov Archive Site
Pittsburgh Sleep Quality Index [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
CBT for Nightmares in OEF/OIF Veterans

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Sleep Disorders
  • Nightmares
  • 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
  • Behavioral: CBT for Insomnia plus psychoeducation
    patients receive standard CBT for insomnia combined with psychoeducation
    Other Name: Sleep and Nightmare Management
  • Experimental: Arm 1
    CBT for Insomnia plus Imagery Rehearsal
    Intervention: Behavioral: CBT for Insomnia plus Imagery Rehearsal
  • Active Comparator: Arm 2
    CBT for Insomnia
    Intervention: Behavioral: CBT for Insomnia plus psychoeducation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
June 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00691626
PT074364
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard J. Ross, MD PhD Philadelphia VA Medical Center
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP