Recruiting

Bipolar Disorder

Sponsor:

Emory University

Code:

NCT02604277

Conditions

Depression

Alcoholism

Drug Abuse

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Interpersonal and Social Rhythm Therapy (ISRT)

Bipolar-Specific Cognitive Behavioral Therapy (CBT)

Mindfulness-Based Stress Reduction (MBSR)

Psycho-education & Understanding Bipolar Medications Therapy

Study Details

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

Depression

Alcoholism

Drug Abuse

Study ID

NCT02604277

Start date

Jan, 2016

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group Intervention Program

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

Interventions

Interpersonal and Social Rhythm Therapy (ISRT)

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.

Bipolar-Specific Cognitive Behavioral Therapy (CBT)

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.

Mindfulness-Based Stress Reduction (MBSR)

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.

Psycho-education & Understanding Bipolar Medications Therapy

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

Primary outcome measure

  • Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Pre-intervention, Post-intervention (Up to six weeks) ]

Central Contacts and Locations

Central contacts

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Principal Investigator:

Dorian Lamis, PhD

More Information

Sponsor

Emory University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Psychology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-07.