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

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder; Nightmares
• Interventions: Behavioral: ERRT-Bipolar Disorder

• Registration Number: NCT02242110
• Lead Sponsor: University of Tulsa

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nightmare Treatment	ERRT-Bipolar Disorder	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.

Primary Outcome Measures

Name	Time	Method
Change in Past Week Nightmare Frequency	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 Outcome Measures

Name	Time	Method
Change in Clinician Administered PTSD Scale Symptoms	Pre, One week, Three Months	This semi-structured clinical interview assesses severity of each of 30 items

Trial Locations

Locations (1)

University of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States