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

May 26, 2015 updated by: Sean P.A. Drummond, University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Veterans Affairs San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • PE
  • IRT
  • Cognitive Behavioral Therapy for Insomnia
  • exposure therapy
Experimental: 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.
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • PE
  • IRT
  • Cognitive Behavioral Therapy for Insomnia
  • exposure therapy
Experimental: 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.
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • PE
  • IRT
  • Cognitive Behavioral Therapy for Insomnia
  • exposure therapy
Behavioral: PTSD + Supportive Care Therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Other Names:
  • PE
  • exposure therapy
Active Comparator: 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.
Behavioral: PTSD + Supportive Care Therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Other Names:
  • PE
  • exposure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nightmares and insomnia symptoms
Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
daytime (non-sleep) PTSD symptoms
Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
health-related quality of life
Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sean PA Drummond, PhD, Veterans Medical Research Foundation & University of California San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1RC1NR011728-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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