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Behavioral Intervention
ERRT for Bipolar Disorder (BERRT Trial)
N/A
Recruiting
Led By Joanne L Davis, PhD
Research Sponsored by University of Tulsa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Formal diagnosis of Bipolar disorder (I or II)
Nightmares at least once per week for the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre, one week, three months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess whether exposure, relaxation, and rescripting therapy (ERRT) is effective in reducing nightmares and improving sleep quality in individuals diagnosed with bipolar disorder.
Who is the study for?
This trial is for adults with Bipolar Disorder (I or II) who have experienced a traumatic event over a month ago and suffer from frequent nightmares. Participants must be stable on bipolar medication for at least two months and not currently experiencing mania/hypomania, recent suicide attempts, hospitalizations, or untreated substance use disorders.
What is being tested?
The study tests ERRT-Bipolar Disorder, a therapy aimed at reducing trauma-related nightmares and improving sleep in those with bipolar disorder. The effectiveness of this psychological intervention will be evaluated by its impact on the frequency and intensity of nightmares.
What are the potential side effects?
While specific side effects are not detailed here, psychological interventions like ERRT may sometimes lead to temporary increases in distress due to confronting traumatic memories during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Bipolar disorder.
Select...
I have experienced nightmares at least once a week for the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre, one week, three months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre, one week, three months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Past Week Nightmare Frequency
Secondary study objectives
Change in Clinician Administered PTSD Scale Symptoms
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nightmare TreatmentExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of TulsaLead Sponsor
15 Previous Clinical Trials
5,081 Total Patients Enrolled
5 Trials studying Nightmares
275 Patients Enrolled for Nightmares
Joanne L Davis, PhDPrincipal InvestigatorUniversity of Tulsa
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Bipolar disorder.You have experienced a traumatic event at least one month before the study starts.I have experienced nightmares at least once a week for the last month.I have been on stable medication for bipolar disorder for at least 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Nightmare Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Nightmares Patient Testimony for trial: Trial Name: NCT02242110 — N/A