Clinical trial NCT01009112: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nightmares
Insomnia
Posttraumatic Stress Disorder
Keywords: Sleep
Sleep Disorder
Veterans
Active Duty
OEF
OIF
PTSD
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2009-11-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: nightmares and insomnia symptoms
timeFrame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Secondary outcomes:
measure: daytime (non-sleep) PTSD symptoms
timeFrame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
measure: health-related quality of life
timeFrame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
Study officials:
affiliation: Veterans Medical Research Foundation & University of California San Diego
name: Sean PA Drummond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.