NCT02242110

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2014May 2027

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

12.9 years

First QC Date

September 11, 2014

Last Update Submit

July 1, 2024

Conditions

NightmaresPost-traumatic Stress Disorder

Keywords

NightmaresSleepPTSDExposure, Relaxation, and Rescripting Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Clinician Administered PTSD Scale Symptoms

    Pre, One week, Three Months

Study Arms (1)

Nightmare Treatment

EXPERIMENTAL

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.

Behavioral: ERRT-Bipolar Disorder

Interventions

ERRT-Bipolar DisorderBEHAVIORAL

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.

Also known as: ERRT
Nightmare Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

RECRUITING

Related 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.

    PMID: 22171201BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Joanne L Davis, PhD

    University of Tulsa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne L Davis, PhD

CONTACT

9186312875joanne-davis@utulsa.edu

Lucia D Villarreal, MS

CONTACT

9186313976ldv0460@utulsa.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 16, 2014

Study Start

June 1, 2014

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)