Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder

Post-traumatic Stress Disorder Clinical Trial

— BERRT  

Official title:

Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242110
• Other study ID #: TU1457R1
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2027

Study information

• Verified date: August 2023
• Source: University of Tulsa
• Contact: Joanne L Davis, PhD
• Phone: 9186312875
• Email: joanne-davis[@]utulsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Nightmares
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• ERRT-Bipolar Disorder
The nightmare treatment, called Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder, is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.

Locations

Country	Name	City	State
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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