Emotional Regulation for Bipolar Disorder

Overseen By Masaya Misaki Study Primary Investigator, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Anxiolytics, Antipsychotics, Antidepressants, others

Disqualifiers: Substance use disorder, Psychosis, others

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

Compensation: Varies

Number of Visits: 3

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how emotions change in people with bipolar disorder compared to those without any psychiatric history. Researchers seek to determine if brain scans can reveal these emotional changes and if strategies to boost positive emotions can help stabilize mood swings. Participants will undergo brain imaging and engage in tasks, including the Think and Regulate Affective State Task, which involves recalling personal memories and practicing emotion regulation. Ideal candidates are individuals with bipolar disorder who are currently feeling depressed or experiencing mixed emotions. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to better emotional management strategies for bipolar disorder.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not changed the dose or prescription of medications like anxiolytics, antipsychotics, antidepressants, or mood stabilizers in the 6 weeks before enrolling. If you're taking drugs that affect the fMRI response, like methylphenidate, you may need to stop.

What prior data suggests that this protocol is safe for participants?

In a previous study, participants completed the Think and Regulate Affective States Task (TReAT) without major safety concerns. This task involves recalling personal experiences and practicing ways to enhance positive feelings during brain scans. Designed to be low-risk, it focuses on managing emotions. No reports of negative effects from this task suggest that TReAT is well-tolerated by participants. As the study is non-invasive and uses standard imaging methods, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Think and Regulate Affective State Task" because it offers a unique approach to managing bipolar disorder by focusing on emotional regulation through cognitive strategies. Unlike traditional treatments like mood stabilizers and antipsychotics, which primarily target chemical imbalances, this method emphasizes training the brain to enhance positive emotions and manage negative ones. By combining personal memory recall with emotional rating and amplification techniques, this approach could lead to a deeper understanding of emotional dynamics and offer a complementary strategy to pharmacological treatments.

What evidence suggests that the Think and Regulate Affective State Task is effective for emotional regulation in bipolar disorder?

Research has shown that strategies to manage emotions can help control mood swings in people with bipolar disorder. In this trial, all participants will engage in the Think and Regulate Affective State Task (TReAT), which involves recalling personal experiences and practicing ways to boost positive feelings. Studies have found that this task can help stabilize emotions and brain activity by focusing on positive emotions. While traditional treatments like Cognitive Behavioral Therapy (CBT) are less effective for bipolar disorder than for other conditions, emotion-focused strategies like TReAT show promise. Previous research suggests that focusing on positive emotions might reduce mood swings, offering a new way to manage bipolar disorder. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This study is for individuals with bipolar disorder, either currently depressed or in a mixed state, and healthy controls without psychiatric history. Participants will complete questionnaires, recall personal memories, undergo fMRI scans while performing emotional tasks, and have their heart rate and respiration monitored.

Inclusion Criteria

BMI between 18.5 and 38.0 kg/m2 at Screening

Fluent in English

Able to provide informed consent

Exclusion Criteria

No telephone or easy access to a telephone

Significant medical problems as identified by the medical screening questionnaire

A positive test for drugs of abuse, including alcohol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preparation Session

Participants undergo informed consent, psychiatric screening, and complete standardized questionnaires assessing mood, emotion regulation, anxiety, and other factors.

1 day

1 visit (in-person)

MRI Scanning Session

Participants complete resting-state and task-based MRI scans, including the Think and Regulate Affective States Task (TReAT), with physiological monitoring.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI scanning session.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Think and Regulate Affective State Task

Trial Overview The trial investigates emotional fluctuations in people with bipolar disorder using fMRI brain imaging and machine learning. It examines if positive emotion regulation can stabilize mood by comparing the brain activity of those with bipolar disorder to healthy controls during various tasks.

How Is the Trial Designed?

Group I: Decoding Emotional Dynamics Experimental Treatment 1 Intervention

All participants complete the same two-session protocol: a preparation visit with diagnostic interviews and questionnaires, followed by an MRI session including resting-state and task-based scans. During the Think and Regulate Affective States Task (TReAT), participants recall personal positive and negative memories, rate their emotions, and practice positive emotion amplification strategies. Physiological signals are recorded throughout. Both individuals with bipolar disorder and healthy controls complete identical procedures for comparison of brain and emotional dynamics.

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/64/NCT07221864/Prot_000.pdf

Decoding Emotional Dynamics Driving Mood Instability in ... Section F, Think and Regulate Affective. States Task (TReAT):** Increased the number of attention trials from four 3-second trials to six 2- ...

2. patlynk.com patlynk.com/trial/NCT07221864

Emotional Dynamics and Mood Instability in Bipolar Disorder This study is focused on understanding the brain processes involved in the emotional ups and downs experienced by people with bipolar disorder.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8498810/

Cognitive Behavioral Therapy in Treatment of Bipolar Disorder The evidence level of CBT for BD is lower compared to unipolar depression and psychotic disorders. The preventive effect of CBT seems to fade away in patients ...

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2014.00847/full

Emotion Regulation Strategies Can Predict Task-Switching ... This study examined task switching abilities and emotion regulation strategies in euthymic bipolar patients (EBP).

5. elsevier.com elsevier.com/about/press-releases/emotion-focused-therapy-for-bipolar-disorder-targets-the-amygdala

Emotion-focused therapy for bipolar disorder targets the ... Patients with BD experience alternating extreme mood states typically categorized by mania, depression, and impaired social functioning.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221864

Decoding Emotional Dynamics in Bipolar Disorder During the Think and Regulate Affective States Task (TReAT), participants recall personal positive and negative memories, rate their emotions, ...

7. withpower.com withpower.com/clinical-trials/for-bipolar-disorder

Top Bipolar Disorder Clinical Trials | Power The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11732062/

Bipolar disorders: an update on critical aspects - PMC Summary. Bipolar disorders are chronic psychiatric conditions characterized by recurrent episodes of mania and depression.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0149763425000302

Decoding neural circuit dysregulation in bipolar disorder This manuscript underscores the need for an integrative treatment approach that simultaneously targets neural circuits and neurotransmitter systems.