ERRT for Bipolar Disorder

(BERRT Trial)

Overseen By Lucia D Villarreal, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tulsa

Must be taking: Bipolar medication

Disqualifiers: Recent mania, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Exposure, Relaxation, and Rescripting Therapy (ERRT) to assist people with bipolar disorder who experience frequent nightmares and sleep disturbances. The goal is to determine if ERRT can reduce the frequency and intensity of nightmares and enhance sleep quality. The trial seeks participants who have experienced nightmares at least once a week for the past month, have bipolar disorder, and encountered a traumatic event more than a month ago. Participants should have been stable on their bipolar medication for at least two months. As an unphased trial, this study offers a chance to contribute to pioneering research that could improve sleep and quality of life for those with bipolar disorder.

Will I have to stop taking my current medications?

The trial requires that you have been stable on your bipolar medication for at least 2 months, so you will need to continue taking your current medications.

What prior data suggests that ERRT-Bipolar Disorder is safe for individuals with bipolar disorder?

Research has shown that Exposure, Relaxation, and Rescripting Therapy (ERRT) is generally well-received. Trials with non-military adults have proven that ERRT significantly reduces the frequency and severity of nightmares without causing serious side effects, suggesting the therapy is safe for most people.

Early studies are underway to confirm its safety and effectiveness for those with bipolar disorder. Although more research is needed to fully understand its impact on this group, ERRT has not been linked to major negative effects in other populations. Therefore, it appears to be a promising option for individuals dealing with ongoing nightmares and sleep problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ERRT-Bipolar Disorder because it addresses sleep disturbances and trauma-related nightmares in bipolar disorder patients, which are often overlooked by standard treatments like mood stabilizers and antipsychotics. ERRT-Bipolar Disorder is unique in that it combines Exposure, Relaxation, and Rescripting Therapy in a focused, short-term format, consisting of just five weekly sessions. This therapy directly targets nightmares and sleep issues, which can significantly impact mood stability, offering a potentially faster and more targeted improvement in quality of life for those with bipolar disorder.

What evidence suggests that ERRT might be an effective treatment for bipolar disorder?

Research has shown that Exposure, Relaxation, and Rescripting Therapy (ERRT) can reduce the frequency and intensity of nightmares. It also appears to improve sleep quality for individuals who have experienced trauma. Although more research is needed specifically for those with bipolar disorder, early results suggest these benefits might also apply to them. In this trial, participants will receive ERRT-Bipolar Disorder, a variant of ERRT, as a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances. ERRT uses mental imagery techniques to help manage upsetting thoughts, which is especially helpful for individuals with intrusive thoughts. These encouraging findings suggest that ERRT could be a useful treatment for nightmares and sleep problems in people with bipolar disorder. ^{1 2 5 6 7}

Who Is on the Research Team?

Joanne L Davis, PhD

Principal Investigator

University of Tulsa

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar Disorder (I or II) who have experienced a traumatic event over a month ago and suffer from frequent nightmares. Participants must be stable on bipolar medication for at least two months and not currently experiencing mania/hypomania, recent suicide attempts, hospitalizations, or untreated substance use disorders.

Inclusion Criteria

I have been diagnosed with Bipolar disorder.

You have experienced a traumatic event at least one month before the study starts.

I have experienced nightmares at least once a week for the last month.

Exclusion Criteria

Intellectual disability

Current or recent mania/hypomania within the last 3 months

Suicide attempt or hospitalization within the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Exposure, Relaxation, and Rescripting Therapy (ERRT) for Bipolar disorder once a week for five consecutive weeks

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1-week, 3-months, and potentially 1-year

1 year

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ERRT-Bipolar Disorder

Trial Overview The study tests ERRT-Bipolar Disorder, a therapy aimed at reducing trauma-related nightmares and improving sleep in those with bipolar disorder. The effectiveness of this psychological intervention will be evaluated by its impact on the frequency and intensity of nightmares.

How Is the Trial Designed?

Group I: Nightmare Treatment Experimental Treatment 1 Intervention

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.

ERRT-Bipolar Disorder is already approved in United States for the following indications:

Approved in United States as ERRT for:

• Trauma-related nightmares
• Sleep disturbances in trauma-exposed adults with bipolar disorder

Who Is Running the Clinical Trial?

University of Tulsa

Lead Sponsor

Trials

16

Recruited

5,100+

Published Research Related to This Trial

Adjunctive psychosocial interventions, such as psychoeducation and cognitive behavior therapy, can enhance the effectiveness of pharmacotherapy in treating bipolar disorder, leading to fewer episodes and hospitalizations.

Cognitive behavior therapy, in particular, has shown significant benefits in reducing bipolar episodes and improving overall functioning, although its specific mechanism of action remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted psychosocial interventions for bipolar disorder. Zaretsky, A.[2019]

In a study of 110 young adults, those with significant hypomanic experiences (high Mood Disorder Questionnaire scores) reported about twice as many intrusive images after watching a trauma film compared to those with low scores, indicating a link between hypomania and increased intrusive imagery.

The findings suggest that intrusive mental imagery may play a role in mood instability in bipolar disorder, highlighting the potential for cognitive treatments that target these intrusive images to help manage symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypomanic Experience in Young Adults Confers Vulnerability to Intrusive Imagery After Experimental Trauma: Relevance for Bipolar Disorder. Malik, A., Goodwin, GM., Hoppitt, L., et al.[2022]

A new psychological intervention called Imagery Based Emotion Regulation (IBER) is being tested for its feasibility in treating anxiety in individuals with bipolar disorder, with 60 participants involved in the trial.

The study aims to determine if IBER can effectively help manage intrusive emotional mental images that contribute to anxiety and mood instability, potentially leading to a larger trial if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IBER study: study protocol for a feasibility randomised controlled trial of Imagery Based Emotion Regulation for the treatment of anxiety in bipolar disorder. Steel, C., Wright, K., Goodwin, G., et al.[2022]

In a study involving 345 participants, including 106 with bipolar disorder, it was found that while emotional imagery quality was similar across groups, the appraisals of imagery significantly differed, particularly between those with and without mood disorders.

Imagery was reported to amplify emotions in all groups, but only individuals with bipolar disorder experienced this amplification as influencing their behavior, especially during manic or depressed states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. van den Berg, KC., Voncken, M., Hendrickson, AT., et al.[2023]

Cognitive behavior therapy (CBT) is an effective treatment approach for patients with bipolar disorder, focusing on modifying negative thought patterns and behaviors.

The therapy aims to help patients manage their symptoms, improve mood stability, and enhance overall functioning, although specific techniques and outcomes were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for bipolar disorders]. Lotufo Neto, F.[2019]

In a pilot study involving 20 bipolar patients with traumatic histories, those receiving Eye Movement Desensitization and Reprocessing (EMDR) therapy showed significant improvements in depressive and hypomanic symptoms, as well as trauma-related symptoms, compared to those receiving standard treatment.

The benefits of EMDR therapy were partially maintained at a 24-week follow-up, suggesting it may be a safe and effective intervention for managing mood and trauma symptoms in bipolar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study. Novo, P., Landin-Romero, R., Radua, J., et al.[2018]

Imagery Based Emotion Regulation (IBER) was tested in a study with 57 participants diagnosed with bipolar disorder, showing high retention rates (96% attended at least 7 sessions) and no serious adverse events, indicating it is a safe intervention.

The study demonstrated that IBER, when combined with usual treatment, is feasible and may positively impact anxiety, depression, and mood stability, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IBER study: a feasibility randomised controlled trial of imagery based emotion regulation for the treatment of anxiety in bipolar disorder. Steel, C., Wright, K., Goodwin, GM., et al.[2023]

Patients with bipolar disorder scored significantly higher on mental imagery measures compared to healthy controls, indicating that mental imagery may amplify mood and contribute to the disorder.

Those with unstable mood in bipolar disorder exhibited more intrusive prospective imagery, which correlated with higher levels of anxiety and depression, suggesting that addressing these imagery processes could be important in cognitive behavior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mood stability versus mood instability in bipolar disorder: a possible role for emotional mental imagery. Holmes, EA., Deeprose, C., Fairburn, CG., et al.[2022]

A study involving 12 adults with acute bipolar depression found that an adapted version of Behavioral Activation (BA) was feasible and well-accepted, with high retention rates (11 out of 12 participants completed the therapy).

No serious adverse events or worsening of manic symptoms were reported, and six out of nine participants with stable baselines showed clinically significant improvement, indicating potential benefits of BA for treating bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. Wright, K., Mostazir, M., Bailey, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02242110?term=AREA%5BBasicSearch%5D(Bipolar%20Disorder)&rank=1

NCT02242110 | Brief Treatment for Trauma Nightmares in ... This pilot study will examine the efficacy of Exposure, Relaxation, & Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3227708/

Physiological Predictors of Response to Exposure ... This randomized clinical trial replicated a study of exposure, relaxation, and rescripting therapy(ERRT) and extended prior research.

3. withpower.com withpower.com/trial/errt-for-bipolar-disorder-b4678

ERRT for Bipolar Disorder (BERRT Trial) ERRT-Bipolar Disorder is unique because it focuses on using imagery techniques to help patients manage intrusive and distressing mental images, which are common ...

4. sites.utulsa.edu sites.utulsa.edu/errt/empirical-research/

Empirical Research – ERRT - Sites at TU Below you will find citations and abstracts of the empirical and scientific literature related to Exposure, Relaxation, and Rescripting Therapy (ERRT). Due to ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.866144/full

Nightmare Rescripting: Using Imagery Techniques to Treat ... This article aims to outline the incidence and consequences of nightmares in PTSD, illustrate how IRT could prove useful in their treatment, and investigate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7868955/

Exposure, relaxation, and rescripting therapy could treat ... Three randomized clinical trials conducted with civilian adult populations have shown that ERRT can significantly reduce nightmare frequency and severity, as ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02242110/brief-treatment-for-trauma-nightmares-in-trauma-exposed-adults-with-bipolar-disorder

Brief Treatment for Trauma Nightmares in Trauma-exposed ... This pilot study will examine the efficacy of Exposure, Relaxation, & Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults ...