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

This study is currently recruiting participants.

Verified January 2013 by Department of Veterans Affairs

Sponsor:

Information provided by (Responsible Party):

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00691626

First received: June 2, 2008

Last updated: January 8, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 2, 2008

Last Updated Date

January 8, 2013

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Nightmare Frequency Questionnaire [ Time Frame: post-treatment ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00691626 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pittsburgh Sleep Quality Index [ Time Frame: post-treatment, 3 month and 6-month follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

CBT for Nightmares in OEF/OIF Veterans

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Posttraumatic Stress Disorder
Sleep Disorders
Nightmares

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

115

Estimated Completion Date

July 2014

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gerlinde C Harb, PhD	(215) 823-5800 ext 6128	harb_g@mail.trc.upenn.edu
Contact: Richard Ross, MD PhD	(215) 823-5800 ext 4046	Richard.Ross2@va.gov

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00691626

Other Study ID Numbers ^ICMJE

PT074364

Has Data Monitoring Committee

Yes

Responsible Party

Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard Ross, MD PhD

VA Medical Center, Philadelphia

Information Provided By

Department of Veterans Affairs

Verification Date

January 2013

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

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