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

NCT00691626 | Completed DMC

• 1 other identifier: PT074364
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Sleep Disorders; Nightmares

Keywords

posttraumatic stress; nightmares; sleep; psychotherapy; imagery rehearsal; insomnia; behavioral treatment; veterans; Operation Iraqi Freedom; Operation Enduring Freedom

Outcome Measures

Primary Outcomes (1)

• 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.

  post-treatment, 3 month and 6-month follow-up

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index

  post-treatment, 3 month and 6-month follow-up

Study Arms (2)

Arm 1: CBT for Insomnia plus Imagery Rehearsal

EXPERIMENTAL

CBT for Insomnia plus Imagery Rehearsal

Behavioral: CBT for Insomnia plus Imagery Rehearsal

Arm 2: CBT for Insomnia

ACTIVE COMPARATOR

CBT for Insomnia

Behavioral: CBT for Insomnia plus psychoeducation

Interventions

CBT for Insomnia plus Imagery Rehearsal BEHAVIORAL

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

Arm 1: CBT for Insomnia plus Imagery Rehearsal

CBT for Insomnia plus psychoeducation BEHAVIORAL

patients receive standard CBT for insomnia combined with psychoeducation

Also known as: Sleep and Nightmare Management

Arm 2: CBT for Insomnia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 28110112 RESULT

• 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.

  PMID: 31053215 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial comparing two forms of psychotherapy.

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 5, 2008
• Study Start: April 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: December 31, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)