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

Sponsor

University of Tulsa (Other)

Overall Status

Recruiting

CT.gov ID

NCT02242110

Collaborator

(none)

Enrollment

Location

Arm

155

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nightmares Post-traumatic Stress Disorder	Behavioral: ERRT-Bipolar Disorder	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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. Other Names: ERRT

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Other Names:

ERRT

Outcome Measures

Primary Outcome Measures

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

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