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

Study Overview
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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.

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

Conditions
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Nightmares, Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: ERRT-Bipolar Disorder


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nightmare Treatment<br>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<br>* 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.<br>* Other names: ERRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scale Symptoms | This semi-structured clinical interview assesses severity of each of 30 items | Pre, One week, Three Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nightmares, Sleep, PTSD, Exposure, Relaxation, and Rescripting Therapy