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

Not Applicable

Completed

• Conditions: Nightmares; Insomnia; Posttraumatic Stress Disorder

• Registration Number: NCT01009112
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Start: 2010-01
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
nightmares and insomnia symptoms	pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Veterans Affairs San Diego Healthcare System; 🇺🇸 San Diego, California, United States