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NCT Number: NCT02242110

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERRT-Bipolar Disorder

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.

Other names: ERRT

Primary outcomes

  1. Change in Past Week Nightmare Frequency

    Time frame: Pre, One week, Three Months

    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 outcomes

  1. Change in Clinician Administered PTSD Scale Symptoms

    Time frame: Pre, One week, Three Months

    This semi-structured clinical interview assesses severity of each of 30 items

Study contacts

Contact information is provided by the study sponsor or research team.

Joanne L Davis, PhD

CONTACT

[email protected]

9186312875

Lucia D Villarreal, MS

CONTACT

[email protected]

9186313976

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Official study title

Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder

Acronym: BERRT

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2014
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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