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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009112
• Other study ID #: 1RC1NR011728-01
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: May 26, 2015
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Nightmares
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
• PTSD + Supportive Care Therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy

Locations

Country	Name	City	State
United States	Veterans Affairs San Diego Healthcare System	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nightmares and insomnia symptoms		pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment	No
Secondary	daytime (non-sleep) PTSD symptoms		pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment	No
Secondary	health-related quality of life		pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment	No