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

Posttraumatic Stress Disorder Clinical Trial

Official title:

CBT for Nightmares in OEF/OIF Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691626
• Other study ID #: PT074364
• Status: Completed
• Phase: N/A
• Start date: April 1, 2009
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 31, 2019
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Nightmares
• Posttraumatic Stress Disorder
• Sleep Disorders
• Sleep Wake Disorders
• Stress Disorders, Post-Traumatic

Intervention

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
• CBT for Insomnia plus psychoeducation
patients receive standard CBT for insomnia combined with psychoeducation

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pittsburgh Sleep Quality Index	This is a standard instrument for measuring basic sleep parameters.	post-treatment, 3 month and 6-month follow-up