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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009112

Enrollment

Registered

2009-11-06

Start date

2010-01-31

Completion date

2012-11-30

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Nightmares, Posttraumatic Stress Disorder

Keywords

Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD

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.

Interventions

BEHAVIORALPTSD + IRT/CBT-I

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

BEHAVIORALPTSD + Supportive Care Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026