Clinical trial NCT02604277: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Alcoholism
Drug Abuse
Keywords: Psychology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Beck Scale for Suicide Ideation (BSS) Score
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: The Beck Depression Inventory-II (BDI-II)
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Change in Altman Self-Rating Mania Scale (ASRM) Score
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Change in World Health Organization Quality of Life-Brief (WHOQOL-BREF) Score
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Change in Impulsive/Premeditated Aggression Scale (IPAS) Score
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Change in Interpersonal Needs Questionnaire-15 (INQ-15) Score
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
measure: Acquired Capability for Suicide Scale (ACSS) Score
timeFrame: Post-intervention (Up to six weeks)
measure: Psychache Scale Score
timeFrame: Post-intervention (Up to six weeks)
Secondary outcomes:
measure: Change in the Demographic Data Form Answers
timeFrame: Pre-intervention, Post-intervention (Up to six weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Dorian Lamis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.