Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMay 28, 2015
May 1, 2015
2.6 years
November 5, 2009
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
nightmares and insomnia symptoms
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Secondary Outcomes (2)
daytime (non-sleep) PTSD symptoms
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
health-related quality of life
pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Study Arms (4)
CBT for Insomnia
EXPERIMENTALPatients 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
Imagery Rehearsal Therapy
EXPERIMENTALPatients "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.
Prolonged Exposure
EXPERIMENTALThis 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.
Suportive Care Therapy
ACTIVE COMPARATORThis 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.
Interventions
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161, United States
Related Publications (2)
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.
PMID: 33472513DERIVEDWalters 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.
PMID: 31246050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean PA Drummond, PhD
Veterans Medical Research Foundation & University of California San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
January 1, 2010
Primary Completion
August 1, 2012
Study Completion
November 1, 2012
Last Updated
May 28, 2015
Record last verified: 2015-05