Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

NCT ID: NCT02604277

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2026-12-31

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

Bipolar disorder (BD) is a severe, chronic, and relatively common psychiatric illness associated with significant premature mortality, including death by suicide. Given that suicidal behavior is a major public health problem and BD confers the highest risk of suicide among major mental disorders, it is important for clinical researchers to investigate why individuals with BD are at an increased risk for suicidal thoughts and behaviors. Among those diagnosed with BD, approximately 75% of patients experience suicidal ideation in their lifetime, 30% attempt suicide, and about 20% eventually die by suicide. Research has also demonstrated that suicidal acts in BD patients tend to be more lethal as indicated by a lower ratio of attempted suicide to death than in the general population. Given that BD patients use more dangerous suicide methods and die by suicide at an alarmingly high rate, early identification and appropriate treatment are critical. Thus, the proposed study should provide critical information and inform treatment efforts regarding suicide risk in low income BD patients.

Research has consistently demonstrated that childhood maltreatment, including abuse and neglect, are independently associated with increased risk for suicidal ideation/behavior in a variety of populations, including patients diagnosed with BD. Consequently, inquiring about past childhood abuse and neglect when assessing suicide risk in this vulnerable population is important. Moreover, childhood maltreatment has been shown to contribute to impulsive aggression and adult drug use, both of which have been shown to predict suicidal behavior in BD patients. Castroman and colleagues (2014) demonstrated that impulsive aggression was an intermediate factor linking childhood abuse with the severity of suicidal behavior in a large sample of suicide attempters. Similarly, Roy (2011) found that impulsive aggression was a significant mediator in the association between childhood abuse and suicidal behavior in substance-dependent patients. With regards to substance use, current evidence suggests that among individuals abused in childhood, the risk for drug use and subsequent suicidal behavior is increased. Further, among BD patients in particular, there appears to be significant additive effects of childhood maltreatment and drug abuse on suicide attempts.

The associations among these variables may be best explained by the interpersonal-psychological theory of suicide (IPTS), which provides a conceptual framework for understanding why individuals consider and engage in suicidal behavior. The theory differentiates between the desire for suicide and the capability of engaging in suicide behaviors among suicide attempters. Desire is characterized by two constructs, perceived burdensomeness (i.e., one's death is worth more than one's life to others) and thwarted belongingness (i.e., sense of alienation and disconnection). Suicide attempts and deaths are arguably related to the ability to use lethal means on one's self, and require pain tolerance and a developed sense of fearlessness in the face of death. Specifically, Joiner (2005) posits that the capability to initiate suicidal behavior is acquired via exposure to painful and fear-provoking events (e. g., childhood maltreatment) that habituate individuals to the pain and fear associated with death. Consequently, understanding pathways by which distal factors, such as childhood maltreatment, may influence suicidal capability is crucial. The proposed investigation of potential developmental pathways from childhood maltreatment to suicidal behaviors through the risk factors of impulsive aggression and drug use may elucidate the associations among these variables, and subsequently improve the assessment and treatment of suicidal BD patients. Thus, the proposed investigation will focus on the capability to engage in suicidal behaviors as examining all ITPS constructs is beyond the scope of this study. More specifically, the researchers propose to examine the relationships between these environmental and psychological factors in BP patients.

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.

Conditions

Depression; Alcoholism; Drug Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Intervention Program

Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.

Group Type: EXPERIMENTAL

Interpersonal and Social Rhythm Therapy (ISRT)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Dorian Lamis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorian Lamis, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dorian Lamis, PhD

Role: CONTACT

dorian.lamis@emory.edu

(404) 616-3533

Facility Contacts

Dorian Lamis, PhD

Role: primary

dorian.lamis@emory.edu

(404) 616-3533

References

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.

Reference Type: DERIVED

PMID: 32579284 (View on PubMed)

Other Identifiers

2025P010887

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00084800

Identifier Type: -

Identifier Source: org_study_id