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

NCT ID: NCT00691626

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder Sleep Disorders Nightmares

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial comparing two forms of psychotherapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1: CBT for Insomnia plus Imagery Rehearsal

CBT for Insomnia plus Imagery Rehearsal

Group Type EXPERIMENTAL

CBT for Insomnia plus Imagery Rehearsal

Intervention Type BEHAVIORAL

patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress

Arm 2: CBT for Insomnia

CBT for Insomnia

Group Type ACTIVE_COMPARATOR

CBT for Insomnia plus psychoeducation

Intervention Type BEHAVIORAL

patients receive standard CBT for insomnia combined with psychoeducation

Interventions

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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

Intervention Type BEHAVIORAL

CBT for Insomnia plus psychoeducation

patients receive standard CBT for insomnia combined with psychoeducation

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleep and Nightmare Management

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard J. Ross, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Ilan Harpaz-Rotem, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

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

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 28110112 (View on PubMed)

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.

Reference Type RESULT
PMID: 31053215 (View on PubMed)

Other Identifiers

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PT074364

Identifier Type: -

Identifier Source: org_study_id

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