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

Primary Purpose

Nightmares, Post-traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ERRT-Bipolar Disorder
Sponsored by
University of Tulsa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nightmares focused on measuring Nightmares, Sleep, PTSD, Exposure, Relaxation, and Rescripting Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of TulsaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nightmare Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Clinician Administered PTSD Scale Symptoms
This semi-structured clinical interview assesses severity of each of 30 items

Full Information

First Posted
September 11, 2014
Last Updated
August 21, 2023
Sponsor
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT02242110
Brief Title
Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder
Acronym
BERRT
Official Title
Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tulsa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmares, Post-traumatic Stress Disorder
Keywords
Nightmares, Sleep, PTSD, Exposure, Relaxation, and Rescripting Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nightmare Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ERRT-Bipolar Disorder
Other Intervention Name(s)
ERRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Past Week Nightmare Frequency
Description
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).
Time Frame
Pre, One week, Three Months
Secondary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale Symptoms
Description
This semi-structured clinical interview assesses severity of each of 30 items
Time Frame
Pre, One week, Three Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne L Davis, PhD
Phone
9186312875
Email
joanne-davis@utulsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia D Villarreal, MS
Phone
9186313976
Email
ldv0460@utulsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne L Davis, PhD
Organizational Affiliation
University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne L Davis, PhD
Phone
918-631-3976
Email
joanne-davis@utulsa.edu
First Name & Middle Initial & Last Name & Degree
Lucia D Villarreal, MS
Phone
918-379-0426
Email
ldv0460@utulsa.edu
First Name & Middle Initial & Last Name & Degree
Joanne L Davis, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22171201
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.
Results Reference
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Learn more about this trial

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

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