Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Primary Purpose
Depression, Alcoholism, Drug Abuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal and Social Rhythm Therapy (ISRT)
Bipolar-Specific Cognitive Behavioral Therapy (CBT)
Mindfulness-Based Stress Reduction (MBSR)
Psycho-education & Understanding Bipolar Medications Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Psychology
Eligibility Criteria
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
Sites / Locations
- Grady Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group Intervention Program
Arm Description
Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02604277
Brief Title
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Official Title
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Alcoholism, Drug Abuse
Keywords
Psychology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Intervention Program
Arm Type
Experimental
Arm Description
Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal and Social Rhythm Therapy (ISRT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bipolar-Specific Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education & Understanding Bipolar Medications Therapy
Intervention Description
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 Information:
Title
Change in Beck Scale for Suicide Ideation (BSS) Score
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Columbia-Suicide Severity Rating Scale
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
The Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Change in Altman Self-Rating Mania Scale (ASRM) Score
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Change in World Health Organization Quality of Life-Brief (WHOQOL-BREF) Score
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Change in Impulsive/Premeditated Aggression Scale (IPAS) Score
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Change in Interpersonal Needs Questionnaire-15 (INQ-15) Score
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
Title
Acquired Capability for Suicide Scale (ACSS) Score
Description
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.
Time Frame
Post-intervention (Up to six weeks)
Title
Psychache Scale Score
Description
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.
Time Frame
Post-intervention (Up to six weeks)
Secondary Outcome Measure Information:
Title
Change in the Demographic Data Form Answers
Description
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.
Time Frame
Pre-intervention, Post-intervention (Up to six weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorian Lamis, PhD
Phone
(404) 616-3533
Email
dorian.lamis@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorian Lamis, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorian Lamis, PhD
Phone
404-616-3533
Email
dorian.lamis@emory.edu
First Name & Middle Initial & Last Name & Degree
Dorian Lamis, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32579284
Citation
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.
Results Reference
derived
Learn more about this trial
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
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