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OpenTrials
Completed

NCT Number: NCT01009112

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

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.

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Key information

Conditions

Nightmares Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Posttraumatic Stress Disorder Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PTSD + IRT/CBT-I

Behavioral

6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia

Other names: IRT, PE, exposure therapy, Cognitive Behavioral Therapy for Insomnia

PTSD + Supportive Care Therapy

Behavioral

6 weeks of prolonged exposure + 12 weeks of supportive care therapy

Other names: PE, exposure therapy

Primary outcomes

  1. nightmares and insomnia symptoms

    Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

Secondary outcomes

  1. daytime (non-sleep) PTSD symptoms

    Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

  2. health-related quality of life

    Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2009
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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