Clinical trial NCT02242110: Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder
Official title: Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nightmares
Post-traumatic Stress Disorder
Keywords: Nightmares
Sleep
PTSD
Exposure, Relaxation, and Rescripting Therapy
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This pilot study will examine the efficacy of Exposure, Relaxation, \& Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder (B-ERRT), as these individuals have been excluded from past clinical trials. Eligible participants will be assessed prior to starting treatment. B-ERRT will be conducted once a week for approximately five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psychoeducation regarding trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques, exposure to the trauma-nightmare, and relapse prevention. Participants will then be asked to complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after the end of the treatment.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Past Week Nightmare Frequency
timeFrame: Pre, One week, Three Months
Secondary outcomes:
measure: Change in Clinician Administered PTSD Scale Symptoms
timeFrame: Pre, One week, Three Months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
Study officials:
affiliation: University of Tulsa
name: Joanne L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.