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

Primary Purpose

Nightmares, Insomnia, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTSD + IRT/CBT-I
PTSD + Supportive Care Therapy
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nightmares focused on measuring Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Veterans Affairs San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

CBT for Insomnia

Imagery Rehearsal Therapy

Prolonged Exposure

Suportive Care Therapy

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

nightmares and insomnia symptoms

Secondary Outcome Measures

daytime (non-sleep) PTSD symptoms
health-related quality of life

Full Information

First Posted
November 5, 2009
Last Updated
May 26, 2015
Sponsor
University of California, San Diego
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01009112
Brief Title
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
Official Title
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmares, Insomnia, Posttraumatic Stress Disorder
Keywords
Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for Insomnia
Arm Type
Experimental
Arm Description
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
Arm Title
Imagery Rehearsal Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Prolonged Exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Suportive Care Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PTSD + IRT/CBT-I
Other Intervention Name(s)
IRT, PE, exposure therapy, Cognitive Behavioral Therapy for Insomnia
Intervention Description
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Intervention Type
Behavioral
Intervention Name(s)
PTSD + Supportive Care Therapy
Other Intervention Name(s)
PE, exposure therapy
Intervention Description
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Primary Outcome Measure Information:
Title
nightmares and insomnia symptoms
Time Frame
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Secondary Outcome Measure Information:
Title
daytime (non-sleep) PTSD symptoms
Time Frame
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Title
health-related quality of life
Time Frame
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean PA Drummond, PhD
Organizational Affiliation
Veterans Medical Research Foundation & University of California San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33472513
Citation
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.
Results Reference
derived
PubMed Identifier
31246050
Citation
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.
Results Reference
derived

Learn more about this trial

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

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