Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder (BERRT)
July 1, 2024 updated by: Joanne Davis, University of Tulsa
Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joanne L Davis, PhD
- Phone Number: 9186312875
- Email: joanne-davis@utulsa.edu
Study Contact Backup
- Name: Lucia D Villarreal, MS
- Phone Number: 9186313976
- Email: LDV0460@utulsa.edu
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104
- Recruiting
- University of Tulsa
-
Principal Investigator:
- Joanne L Davis, PhD
-
Contact:
- Joanne L Davis, PhD
- Phone Number: 918-631-3976
- Email: joanne-davis@utulsa.edu
-
Contact:
- Lucia D Villarreal, MS
- Phone Number: 918-379-0426
- Email: ldv0460@utulsa.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nightmare Treatment
The nightmare treatment, Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder (ERRT-Bipolar Disorder), is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Past Week Nightmare Frequency
Time Frame: Pre, One week, Three Months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Clinician Administered PTSD Scale Symptoms
Time Frame: Pre, One week, Three Months
|
This semi-structured clinical interview assesses severity of each of 30 items
|
Pre, One week, Three Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne l Davis, PhD, University of Tulsa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
September 11, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimated)
September 16, 2014
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU1457R1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.