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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
  Purpose
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.

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
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
Official Title: CBT for Nightmares in OEF/OIF Veterans

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 140
Actual Study Start Date: April 1, 2009
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: January 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: CBT for Insomnia plus Imagery Rehearsal
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
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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691626

Locations
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00691626     History of Changes
Other Study ID Numbers: PT074364
Study First Received: June 2, 2008
Last Updated: May 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
posttraumatic stress
nightmares
sleep
psychotherapy
imagery rehearsal
insomnia
behavioral treatment
veterans
Operation Iraqi Freedom
Operation Enduring Freedom

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 17, 2017