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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT01009112

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nightmares Insomnia Posttraumatic Stress Disorder	Behavioral: PTSD + IRT/CBT-I Behavioral: PTSD + Supportive Care Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT for Insomnia 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	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 Other Names: IRT PE exposure therapy Cognitive Behavioral Therapy for Insomnia
Experimental: Imagery Rehearsal Therapy 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.	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 Other Names: IRT PE exposure therapy Cognitive Behavioral Therapy for Insomnia
Experimental: Prolonged Exposure 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.	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 Other Names: IRT PE exposure therapy Cognitive Behavioral Therapy for Insomnia Behavioral: PTSD + Supportive Care Therapy 6 weeks of prolonged exposure + 12 weeks of supportive care therapy Other Names: PE exposure therapy
Active Comparator: Suportive 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.	Behavioral: PTSD + Supportive Care Therapy 6 weeks of prolonged exposure + 12 weeks of supportive care therapy Other Names: PE exposure therapy

Outcome Measures

Primary Outcome Measures

nightmares and insomnia symptoms [pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment]

Secondary Outcome Measures

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]