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

Not Applicable

Completed

• Conditions: Nightmares; Insomnia; Posttraumatic Stress Disorder
• Interventions: Behavioral: PTSD + IRT/CBT-I; Behavioral: PTSD + Supportive Care Therapy

• 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

Arm && Interventions

Group	Intervention	Description
Imagery Rehearsal Therapy	PTSD + IRT/CBT-I	Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too.
CBT for Insomnia	PTSD + IRT/CBT-I	Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time
Prolonged Exposure	PTSD + IRT/CBT-I	This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.
Prolonged Exposure	PTSD + Supportive Care Therapy	This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.
Suportive Care Therapy	PTSD + Supportive Care Therapy	This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms.

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