Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

Not Applicable

Recruiting

• Conditions: Alcoholism; Drug Abuse; Depression
• Interventions: 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

• Registration Number: NCT02604277
• Lead Sponsor: Emory University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Study Start: 2016-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group Intervention Program	Mindfulness-Based Stress Reduction (MBSR)	Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Group Intervention Program	Bipolar-Specific Cognitive Behavioral Therapy (CBT)	Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Group Intervention Program	Psycho-education & Understanding Bipolar Medications Therapy	Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Group Intervention Program	Interpersonal and Social Rhythm Therapy (ISRT)	Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in the Demographic Data Form Answers	Pre-intervention, Post-intervention (Up to six weeks)	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.

Trial Locations

Locations (1)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States