Skip to main content
OpenTrials
Completed

NCT Number: NCT00691626

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posttraumatic Stress Disorder Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Nightmares Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

CBT for Insomnia plus psychoeducation

Behavioral

patients receive standard CBT for insomnia combined with psychoeducation

Other names: Sleep and Nightmare Management

Primary outcomes

  1. Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire

    Time frame: post-treatment, 3 month and 6-month follow-up

    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.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: post-treatment, 3 month and 6-month follow-up

    This is a standard instrument for measuring basic sleep parameters.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

CBT for Nightmares in OEF/OIF Veterans

Important dates

Study start
2009
Primary completion
2015
Study completion
2019
First posted
Jun 5, 2008
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.