Psycho-education & Understanding Bipolar Medications Therapy for Depression

Grady Health System, Atlanta, GA
Depression+2 More ConditionsPsycho-education & Understanding Bipolar Medications Therapy - Behavioral
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Depression
  • Substance Abuse
  • Alcoholism

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

9 Primary · 1 Secondary · Reporting Duration: Pre-intervention, Post-intervention (Up to six weeks)

Post-intervention (Up to six weeks)
Acquired Capability for Suicide Scale (ACSS) Score
Psychache Scale Score
Pre-intervention, Post-intervention (Up to six weeks)
Change in Altman Self-Rating Mania Scale (ASRM) Score
Change in Beck Scale for Suicide Ideation (BSS) Score
Change in Impulsive/Premeditated Aggression Scale (IPAS) Score
Change in Interpersonal Needs Questionnaire-15 (INQ-15) Score
Change in World Health Organization Quality of Life-Brief (WHOQOL-BREF) Score
Change in the Demographic Data Form Answers
Columbia-Suicide Severity Rating Scale
The Beck Depression Inventory-II (BDI-II)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Group Intervention Program
1 of 1

Experimental Treatment

130 Total Participants · 1 Treatment Group

Primary Treatment: Psycho-education & Understanding Bipolar Medications Therapy · No Placebo Group · N/A

Group Intervention ProgramExperimental Group · 4 Interventions: Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT), Mindfulness-Based Stress Reduction (MBSR), Psycho-education & Understanding Bipolar Medications Therapy · Intervention Types: Behavioral, Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction (MBSR)
2016
Completed Phase 2
~1260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention, post-intervention (up to six weeks)

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,611 Total Patients Enrolled
57 Trials studying Depression
8,533 Patients Enrolled for Depression
Dorian Lamis, PhDPrincipal Investigator - Emory University
Emory University

Eligibility Criteria

Age 18 - 64 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Bipolar Disorder.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Grady Health System100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%