Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

NCT ID: NCT00108628

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2013-07-31

Brief Summary

The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.

Detailed Description

Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Imagery Rehearsal Therapy

Group Type: EXPERIMENTAL

Imagery Rehearsal

Intervention Type: BEHAVIORAL

IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.

Arm 2

Sleep and Nightmare Management

Group Type: ACTIVE_COMPARATOR

Sleep and Nightmare Management

Intervention Type: BEHAVIORAL

This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets

Interventions

Imagery Rehearsal

IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.

Intervention Type: BEHAVIORAL

Sleep and Nightmare Management

This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male
• Vietnam Combat Veteran
• Diagnosis of combat-related PTSD
• Stable psychotropic regimen for a minimum of three months
• Experiences recurrent nightmares

Exclusion Criteria

• Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
• Schizophrenia and other psychotic disorders
• Substance abuse or dependence within the last six months
• Untreated medical disorders known to impact sleep

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard J. Ross, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center

Locations

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Harb GC, Thompson R, Ross RJ, Cook JM. Combat-related PTSD nightmares and imagery rehearsal: nightmare characteristics and relation to treatment outcome. J Trauma Stress. 2012 Oct;25(5):511-8. doi: 10.1002/jts.21748. Epub 2012 Oct 9.

Reference Type: RESULT

PMID: 23047646 (View on PubMed)

Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, Ross RJ. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010 Oct;23(5):553-63. doi: 10.1002/jts.20569.

Reference Type: RESULT

PMID: 20839311 (View on PubMed)

Cook JM, Thompson R, Harb GC, Ross RJ. Cognitive-behavioral treatment for posttraumatic nightmares: An investigation of predictors of dropout and outcome. Psychological trauma : theory, research, practice and policy. 2013 Nov 1; 5(6):545-553.

Reference Type: RESULT

Other Identifiers

CLIN-018-03S

Identifier Type: -

Identifier Source: org_study_id