Clinical trial NCT00691626: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial comparing two forms of psychotherapy.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
timeFrame: post-treatment, 3 month and 6-month follow-up
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: post-treatment, 3 month and 6-month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Richard J. Ross, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Ilan Harpaz-Rotem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.