Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Alcoholism, Drug Abuse

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Intervention Program<br>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)<br>* 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.<br>Behavioral: Bipolar-Specific Cognitive Behavioral Therapy (CBT)<br>* 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.<br>Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* 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.<br>Behavioral: Psycho-education & Understanding Bipolar Medications Therapy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychology