Post-traumatic Stress Disorder Clinical Trial
— BERRTOfficial title:
Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder
NCT number | NCT02242110 |
Other study ID # | TU1457R1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | May 2027 |
Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Nightmares at least once per week for the past month - Formal diagnosis of Bipolar disorder (I or II) - Exposure to traumatic event (1+ months ago) - Stable on bipolar medication for at least 2 months Exclusion Criteria: - A traumatic event within the last month - Intellectual disability - Current or recent mania/hypomania within the last 3 months - Suicide attempt or hospitalization within the last 3 months - Current or untreated substance use disorder within the past 6 months |
Country | Name | City | State |
---|---|---|---|
United States | University of Tulsa | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Tulsa |
United States,
Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Past Week Nightmare Frequency | This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Higher values indicate more nightmares (worse outcome). | Pre, One week, Three Months | |
Secondary | Change in Clinician Administered PTSD Scale Symptoms | This semi-structured clinical interview assesses severity of each of 30 items | Pre, One week, Three Months |
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