Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

NCT02604277 | Recruiting

• 2 other identifiers: IRB000848002025P010887
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.

Conditions

Alcoholism; Drug Abuse; Depression

Keywords

Psychology

Outcome Measures

Primary Outcomes (1)

• Columbia-Suicide Severity Rating Scale (C-SSRS) Score

  Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) serves as the outcome measure, which assesses the constructs of suicidal behavior (i.e., actual, aborted, or interrupted attempts), severity, and lethality. Although suicidal behavior is the primary outcome of interest, suicidal ideation (passive, active, intensity) will also be assessed by the C-SSRS. The C-SSRS has four constructs relevant to recent suicidal ideation (SI): 1) severity (1=wish to be dead, 2=nonspecific active suicidal thoughts, 3=suicidal thoughts with methods, 4=suicidal intent, and 5=suicidal intent with plan); 2) intensity (sum across six items each rated 0 to 5: most severe ideation, frequency, duration, controllability, deterrents, and reason); 3) behavior; and 4) lethality.

  Pre-intervention, Post-intervention (Up to six weeks)

Other Outcomes (9)

• Alcohol Use Disorders Identification Test (AUDIT) Score

  Pre-intervention, Post-intervention (Up to six weeks)

• Beck Scale for Suicide Ideation (BSS) Score

  Pre-intervention, Post-intervention (Up to six weeks)

• The Beck Depression Inventory-II (BDI-II)

  Pre-intervention, Post-intervention (Up to six weeks)

Study Arms (1)

Group Intervention Program

EXPERIMENTAL

Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.

Behavioral: Interpersonal and Social Rhythm Therapy (ISRT); Behavioral: Bipolar-Specific Cognitive Behavioral Therapy (CBT); Behavioral: Mindfulness-Based Stress Reduction (MBSR); Behavioral: Psycho-education & Understanding Bipolar Medications Therapy

Interventions

Bipolar-Specific Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Bipolar-Specific Cognitive Behavioral Therapy (CBT) will be given once a week over a six week period for 55-60 minutes.The therapy is directly focused on eliminating or managing specific problems experienced by people with Bipolar Disorder. As part of this intervention, participant's maladaptive thoughts, behaviors and emotions are identified followed by learning how to challenge negative thoughts and reframing into positive, more adaptive thoughts. Additionally, the intervention involves enhancing the participant's coping skills and the ability to view a situation more objectively.

Group Intervention Program

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

Mindfulness-Based Stress Reduction (MBSR) will be given once a week over a six week period for 55-60 minutes. MBSR is a structured intervention that utilizes mindfulness meditation to reduce suffering associated with physical and psychiatric illnesses. MBSR is nonreligious in nature and aims to encourage an enhanced awareness of moment-to-moment experience of noticeable mental processes.

Group Intervention Program

Psycho-education & Understanding Bipolar Medications Therapy BEHAVIORAL

Psycho-education \& Understanding Bipolar Medications Therapy will be given once a week over a six week period for 55-60 minutes. Psycho-education \& Understanding Bipolar Medications Therapy aims to provide psycho-education about Bipolar Depression as well as provide a platform for participants to address concerns about managing their illness. Issues such as managing symptoms, reducing relapses and hospitalizations as well as maintaining gains will be discussed

Group Intervention Program

Interpersonal and Social Rhythm Therapy (ISRT) BEHAVIORAL

Interpersonal and Social Rhythm Therapy (ISRT) will be given once a week over a six week period for 55-60 minutes. ISRT emphasizes identifying and maintaining a regular routine in daily life. It includes addressing sleep and solving interpersonal concerns and conflicts by focusing on daily routine.

Group Intervention Program

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking
• Diagnosis of Bipolar Disorder (BD)
• Able to provide written informed consent

You may not qualify if:

• Cognitive impairments
• Acutely psychotic
• Medically unstable
• History of schizophrenia spectrum disorder
• History of mood incongruent psychotic symptoms
• History of primary substance disorder
• History of primary organic disease and/or dementia

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (1)

• Au JS, Martinez de Andino A, Mekawi Y, Silverstein MW, Lamis DA. Latent class analysis of bipolar disorder symptoms and suicidal ideation and behaviors. Bipolar Disord. 2021 Mar;23(2):186-195. doi: 10.1111/bdi.12967. Epub 2020 Jul 8.

  PMID: 32579284 DERIVED

MeSH Terms

Conditions

Depression; Alcoholism; Substance-Related Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dorian Lamis, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorian Lamis, PhD

CONTACT

(404) 616-3533; dorian.lamis@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)