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

Primary Purpose

Posttraumatic Stress Disorder, Sleep Disorders, Nightmares

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT for Insomnia plus Imagery Rehearsal
CBT for Insomnia plus psychoeducation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress, nightmares, sleep, psychotherapy, imagery rehearsal, insomnia, behavioral treatment, veterans, Operation Iraqi Freedom, Operation Enduring Freedom

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: CBT for Insomnia plus Imagery Rehearsal

Arm 2: CBT for Insomnia

Arm Description

CBT for Insomnia plus Imagery Rehearsal

CBT for Insomnia

Outcomes

Primary Outcome Measures

Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
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
This is a standard instrument for measuring basic sleep parameters.

Full Information

First Posted
June 2, 2008
Last Updated
January 30, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00691626
Brief Title
Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
Official Title
CBT for Nightmares in OEF/OIF Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2009 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Sleep Disorders, Nightmares
Keywords
posttraumatic stress, nightmares, sleep, psychotherapy, imagery rehearsal, insomnia, behavioral treatment, veterans, Operation Iraqi Freedom, Operation Enduring Freedom

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial comparing two forms of psychotherapy.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: CBT for Insomnia plus Imagery Rehearsal
Arm Type
Experimental
Arm Description
CBT for Insomnia plus Imagery Rehearsal
Arm Title
Arm 2: CBT for Insomnia
Arm Type
Active Comparator
Arm Description
CBT for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
CBT for Insomnia plus Imagery Rehearsal
Intervention Description
patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress
Intervention Type
Behavioral
Intervention Name(s)
CBT for Insomnia plus psychoeducation
Other Intervention Name(s)
Sleep and Nightmare Management
Intervention Description
patients receive standard CBT for insomnia combined with psychoeducation
Primary Outcome Measure Information:
Title
Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
Description
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.
Time Frame
post-treatment, 3 month and 6-month follow-up
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
This is a standard instrument for measuring basic sleep parameters.
Time Frame
post-treatment, 3 month and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J. Ross, MD PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilan Harpaz-Rotem, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28110112
Citation
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.
Results Reference
result
PubMed Identifier
31053215
Citation
Harb GC, Cook JM, Phelps AJ, Gehrman PR, Forbes D, Localio R, Harpaz-Rotem I, Gur RC, Ross RJ. Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans. J Clin Sleep Med. 2019 May 15;15(5):757-767. doi: 10.5664/jcsm.7770.
Results Reference
result

Learn more about this trial

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

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