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

January 30, 2020 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a dismantling study with the objective of determining whether imagery rehearsal is essential to the efficacy of imagery rehearsal + CBT-I for improving the sleep and nightmare disturbance in Veterans with PTSD and recurrent nightmares.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Sleep and Nightmare Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post-treatment, 3 month and 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post-treatment, 3 month and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Richard J. Ross, MD PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
  • Principal Investigator: Ilan Harpaz-Rotem, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT074364

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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