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Nightmares Associated With Trauma and Stress |

Nightmares Associated With Trauma and Stress research study

What is the primary objective of this study?

Untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. The study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. It is the first randomized clinical trial with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems and family dysfunction. Therefore, this treatment may prevent long-term secondary health and behavioral problems. It provides a viable healthcare option to Oklahomans, lessening long-term financial medical and behavioral health expenses. Scientific models currently view PTSD treatment as primary, often leaving nightmares untreated. That approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.

Who is eligible to participate?

Inclusion Criteria: - children age 5-17 with traumatic or potentially traumatic/adverse experiences and nightmares occurring at least once per week over a minimum of one month - have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak English Exclusion Criteria: - adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English - in order to ensure the verbal comprehension of the child, the PPVT will be used to help evaluate if a child is suitable for treatment, as an index to ensure they can verbally comprehend the cognitive component of treatment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nightmares Associated With Trauma and Stress

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Behavioral

Waitlist ControlAll potential participants will be evaluated and some will be randomly placed in the control group, following the five-week treatment phase, participants in the control group will be re-evaluated and offered the treatment

Study Status

Completed

Start Date: October 2012

Completed Date: November 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration.

Secondary Outcome: University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (UPID)

Study sponsors, principal investigator, and references

Principal Investigator: Lisa Cromer, Phd

Lead Sponsor: University of Tulsa

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01776229

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