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

NCT ID: NCT02242110

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Nightmares Post-traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ERRT-Bipolar Disorder

Intervention Type BEHAVIORAL

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.

Interventions

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ERRT-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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ERRT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tulsa

OTHER

Sponsor Role lead

Responsible Party

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Joanne Davis

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanne L Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tulsa

Locations

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University of Tulsa

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joanne L Davis, PhD

Role: CONTACT

9186312875

Lucia D Villarreal, MS

Role: CONTACT

9186313976

Facility Contacts

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Joanne L Davis, PhD

Role: primary

918-631-3976

Lucia D Villarreal, MS

Role: backup

918-379-0426

References

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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.

Reference Type BACKGROUND
PMID: 22171201 (View on PubMed)

Other Identifiers

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TU1457R1

Identifier Type: -

Identifier Source: org_study_id

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