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Psycho-education & Understanding Bipolar Medications Therapy + MBSR + ISRT + Bipolar-Specific CBT for Bipolar Disorder
N/A
Recruiting
Led By Dorian Lamis, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Bipolar Disorder (BD)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention, post-intervention (up to six weeks)
Awards & highlights
Study Summary
This trial will study how to better treat bipolar patients who are suicidal by looking at environmental and psychological factors, as well as implementing a 6-week intervention program.
Who is the study for?
This trial is for English-speaking individuals with Bipolar Disorder who can consent to participate. It's not suitable for those with cognitive impairments, organic diseases, dementia, severe substance disorders, acute psychosis, or schizophrenia spectrum disorders.Check my eligibility
What is being tested?
The study tests a 6-week group intervention program that includes Psycho-education & Understanding Bipolar Medications Therapy, Mindfulness-Based Stress Reduction (MBSR), Interpersonal and Social Rhythm Therapy (ISRT), and Bipolar-Specific Cognitive Behavioral Therapy (CBT).See study design
What are the potential side effects?
While this trial focuses on psychological therapies rather than medications, participants may experience emotional discomfort or distress as they confront personal issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Bipolar Disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention, post-intervention (up to six weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention, post-intervention (up to six weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acquired Capability for Suicide Scale (ACSS) Score
Change in Altman Self-Rating Mania Scale (ASRM) Score
Change in Beck Scale for Suicide Ideation (BSS) Score
+6 moreSecondary outcome measures
Change in the Demographic Data Form Answers
Trial Design
1Treatment groups
Experimental Treatment
Group I: Group Intervention ProgramExperimental Treatment4 Interventions
Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction (MBSR)
2018
Completed Phase 2
~1430
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,566 Total Patients Enrolled
3 Trials studying Substance Abuse
849 Patients Enrolled for Substance Abuse
Dorian Lamis, PhDPrincipal Investigator - Emory University
Emory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have problems with thinking or memory.You have a medical condition that is not stable.You have a history of experiencing unrealistic thoughts or beliefs that don't match your mood or emotions.You have a history of a significant brain disorder or dementia.I have been diagnosed with Bipolar Disorder.You have a history of drug or alcohol addiction.You are currently experiencing a severe episode of psychosis.You have been diagnosed with a type of mental illness called schizophrenia spectrum disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Group Intervention Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Grady Health System
What portion of applicants met pre-screening criteria?
Met criteria
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