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Behavioral Intervention
Exposure, Relaxation, and Rescripting Therapy for Trauma Nightmares (ERRT 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
18 years of age or older at the time of the intake
Be older than 18 years old
Must not have
Unmedicated bipolar disorder
Age of 17 or younger
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months followup
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to study the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose effect and mechanism of change.
Who is the study for?
This trial is for adults who have experienced a traumatic event and suffer from frequent trauma-related nightmares, at least once weekly over the past month. Participants must be able to read and speak English. It's not suitable for individuals under 18, those with active suicidal thoughts, unmedicated bipolar disorder, recent substance abuse issues, psychosis, recent self-harm behaviors or intellectual disabilities.
What is being tested?
The study tests Exposure, Relaxation, and Rescripting Therapy (ERRT), a psychological treatment aimed at reducing the frequency and severity of post-trauma nightmares and improving sleep quality. The trial seeks to understand how different components of ERRT contribute to its effectiveness through weekly sessions lasting about 90 minutes each.
What are the potential side effects?
As ERRT is a form of psychotherapy focusing on exposure to traumatic memories in a controlled environment followed by relaxation techniques and cognitive restructuring, side effects may include temporary increases in distress or emotional discomfort during early stages of therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have bipolar disorder and am not taking medication for it.
Select...
I am 17 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months followup
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months followup
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Nightmare Frequency Past Week
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Active Control
Group I: ERRT-SleepActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
Group II: ERRT - Enhanced ExposureActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
Group III: ERRT-RescriptionActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
Group IV: ERRT - Consensus ManualActive Control1 Intervention
Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.
Group V: ERRT - Sleep and RelaxationActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
Find a Location
Who is running the clinical trial?
University of TulsaLead Sponsor
15 Previous Clinical Trials
5,051 Total Patients Enrolled
Joanne L Davis, PhDPrincipal InvestigatorUniversity of Tulsa
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had about one nightmare every week for the last month.I am 18 years old or older.I have had about one nightmare every week for the last month.I have bipolar disorder and am not taking medication for it.I am 17 years old or younger.You have had a very upsetting event that meets the criteria set out by the DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: ERRT-Sleep
- Group 2: ERRT - Enhanced Exposure
- Group 3: ERRT-Rescription
- Group 4: ERRT - Consensus Manual
- Group 5: ERRT - Sleep and Relaxation
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.