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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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00691626
First received: June 2, 2008
Last updated: May 17, 2017
Last verified: May 2017
June 2, 2008
May 17, 2017
April 1, 2009
January 1, 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 ]

The NFQ measures the number of nightmares/week and the number of nights with a nightmare/week.

The NDQ measures the distress associated with nightmare experiences.

Nightmare Frequency Questionnaire [ Time Frame: post-treatment ]
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 ]
This is a standard instrument for measuring basic sleep parameters.
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 Michael J. Crescenz 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
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized controlled trial comparing two forms of psychotherapy.
Masking: Single (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
    CBT for Insomnia plus Imagery Rehearsal
    Intervention: Behavioral: CBT for Insomnia plus Imagery Rehearsal
  • Active Comparator: Arm 2: CBT for Insomnia
    CBT for Insomnia
    Intervention: Behavioral: CBT for Insomnia plus psychoeducation
Scott JC, Harb G, Brownlow JA, Greene J, Gur RC, Ross RJ. Verbal memory functioning moderates psychotherapy treatment response for PTSD-Related nightmares. Behav Res Ther. 2017 Apr;91:24-32. doi: 10.1016/j.brat.2017.01.004. Epub 2017 Jan 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
December 31, 2017
January 1, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently enrolled in treatment in the Michael J. Crescenz 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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00691626
PT074364
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Richard J. Ross, MD PhD Philadelphia VA Medical Center, Philadelphia, PA
Principal Investigator: Ilan Harpaz-Rotem, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
VA Office of Research and Development
May 2017

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