Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

NCT ID: NCT01009112

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-11-30

Brief Summary

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Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.

Detailed Description

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Conditions

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Nightmares Insomnia Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT for Insomnia

Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time

Group Type EXPERIMENTAL

PTSD + IRT/CBT-I

Intervention Type BEHAVIORAL

6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia

Imagery Rehearsal Therapy

Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too.

Group Type EXPERIMENTAL

PTSD + IRT/CBT-I

Intervention Type BEHAVIORAL

6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia

Prolonged Exposure

This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.

Group Type EXPERIMENTAL

PTSD + IRT/CBT-I

Intervention Type BEHAVIORAL

6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia

PTSD + Supportive Care Therapy

Intervention Type BEHAVIORAL

6 weeks of prolonged exposure + 12 weeks of supportive care therapy

Suportive Care Therapy

This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms.

Group Type ACTIVE_COMPARATOR

PTSD + Supportive Care Therapy

Intervention Type BEHAVIORAL

6 weeks of prolonged exposure + 12 weeks of supportive care therapy

Interventions

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PTSD + IRT/CBT-I

6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia

Intervention Type BEHAVIORAL

PTSD + Supportive Care Therapy

6 weeks of prolonged exposure + 12 weeks of supportive care therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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IRT PE exposure therapy Cognitive Behavioral Therapy for Insomnia PE exposure therapy

Eligibility Criteria

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Inclusion Criteria

* 1 or more deployments to OEF or OIF
* Exposure to Trauma
* Nightmares 2 or more times per week
* Insomnia for 1 month or more
* Live in greater San Diego County region

Exclusion Criteria

* Use of medications for sleep or nightmares in the past 2 weeks
* Current enrollment in psychotherapy for PTSD
* Current or recent substance or alcohol abuse or dependence
* Other untreated sleep disorders (e.g., sleep apnea)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Sean P.A. Drummond

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean PA Drummond, PhD

Role: PRINCIPAL_INVESTIGATOR

Veterans Medical Research Foundation & University of California San Diego

Locations

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Veterans Affairs San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

References

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Mascaro L, Phillips AJK, Clark JW, Straus LD, Drummond SPA. Diurnal Rhythm Robustness in Individuals With PTSD and Insomnia and The Association With Sleep. J Biol Rhythms. 2021 Apr;36(2):185-195. doi: 10.1177/0748730420984563. Epub 2021 Jan 20.

Reference Type DERIVED
PMID: 33472513 (View on PubMed)

Walters EM, Jenkins MM, Nappi CM, Clark J, Lies J, Norman SB, Drummond SPA. The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. Psychol Trauma. 2020 Feb;12(2):175-185. doi: 10.1037/tra0000478. Epub 2019 Jun 27.

Reference Type DERIVED
PMID: 31246050 (View on PubMed)

Other Identifiers

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1RC1NR011728-01

Identifier Type: NIH

Identifier Source: org_study_id

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