Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

Depression Clinical Trial

Official title:

Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02604277
• Other study ID #: IRB00084800
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: Dorian Lamis, PhD
• Phone: (404) 616-3533
• Email: dorian.lamis[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients 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. Groups will include topics such as interpersonal/social rhythm and mindfulness interventions, as well as interventions focused on understanding and changing thoughts to better cope with Bipolar Depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Bipolar Disorder
• Depression
• Drug Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Scale for Suicide Ideation (BSS) Score	The BSS is a 21-item self-report instrument assessing individual's thoughts, attitudes and intentions regarding suicide over the past week, including attitudes toward living and dying, expected reactions to these thoughts, and frequency of past suicidal behavior.The items provide participants with three response options (e.g., "I have no wish to die", "I have a weak wish to die", or "I have a moderate to strong wish to die") and are rated on a scale from 0 to 2, based on intensity. Scores are summed to provide a total score indicative of suicide risk. A higher score indicates a higher risk.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Columbia-Suicide Severity Rating Scale	Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) will serve 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.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	The Beck Depression Inventory-II (BDI-II)	The BDI-II is a 21-item self-report measure of the severity of depressive symptoms. The items are scored from 0 to 3 to assess the level of symptom severity. Responses on the items are summed to derive a total scale score, with higher scores suggestive of higher depressive symptom severity.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Change in Altman Self-Rating Mania Scale (ASRM) Score	The ASRM is a self-administered five-item questionnaire regarding mania/hypomania. Each item is rated on a five-point anchored Likert scale, generating total scale scores ranging from 0 to 20. A total score of greater than or equal to 6 indicates symptoms of mania/hypomania.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Change in World Health Organization Quality of Life-Brief (WHOQOL-BREF) Score	The WHOQOL-BREF is an abbreviated 26-item quality of life assessment. It produces scores for four domains of quality of life, namely, physical health, psychological health, social relationships and environment. Higher scores indicate greater satisfaction with life or health and higher quality of life.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Change in Impulsive/Premeditated Aggression Scale (IPAS) Score	The IPAS is a fifteen item questionnaire that assesses impulsive aggression and premeditated aggression. Participants are asked to indicate how much each item characterized a past incident of aggression during the last 6 months and complete the IPAS in relation to those acts on a 5-point Likert scale from strongly agree to strongly disagree. High scores are indicative of greater aggression.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Change in Interpersonal Needs Questionnaire-15 (INQ-15) Score	The INQ- 15 is a measure of perceived burdensomeness and belongingness. All statements are rated on a 7-point scale from 1 (not at all true for me) to 7 (very true for me), with higher summed scores corresponding to higher levels of perceived burdensomeness and belongingness.	Pre-intervention, Post-intervention (Up to six weeks)
Primary	Acquired Capability for Suicide Scale (ACSS) Score	The ACSS is a 7-item self-report instrument designed to assess levels of acquired capability. On each item, participants are asked to report how much they identify with the item, using a 5-point Likert-scale ranging from 0 "Not at All Like Me" to 4 "Very Much Like Me." Total scores may range from 0 to 28, with higher scores indicating greater levels of acquired capability.	Post-intervention (Up to six weeks)
Primary	Psychache Scale Score	The Psychache Scale is a 13- item self-report scale of psychological pain using a 5-point Likert scale.A higher score is predictive of suicidal ideation beyond the influence of depression and hopelessness.	Post-intervention (Up to six weeks)
Secondary	Change in the Demographic Data Form Answers	The Demographic Data Form includes questions about demographics (e.g., age, sex, education, socioeconomic status), family composition (e.g., presence of dependent children, relationship status), living situation (homeless vs. not homeless), legal and psychiatric history. Pertinent changes in housing and legal issues are inquired as part of the post-test survey.	Pre-intervention, Post-intervention (Up to six weeks)