DepressionNCT02604277
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
A study testing Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Alcoholism, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression, Alcoholism, Drug Abuse
- What is being tested?
- Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English speaking
- Diagnosis of Bipolar Disorder (BD)
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Dorian Lamis, PhD, (404) 616-3533, dorian.lamis@emory.edu
Dorian Lamis, PhD
About this study
Official title: Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors
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.
Read the 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
- Being tested
- Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT), Mindfulness-Based Stress Reduction (MBSR), Psycho-education & Understanding Bipolar Medications Therapy
- Keywords
- Psychology
- Medical subject headings
- Depression, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal and Social Rhythm Therapy (ISRT)Behavioural
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)Behavioural
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)Behavioural
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 TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention Program | Experimental | Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) serves 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 C-SSRS has four constructs relevant to recent suicidal ideation (SI): 1) severity (1=wish to be dead, 2=nonspecific active suicidal thoughts, 3=suicidal thoughts with methods, 4=suicidal intent, and 5=suicidal intent with plan); 2) intensity (sum across six items each rated 0 to 5: most severe ideation, frequency, duration, controllability, deterrents, and reason); 3) behavior; and 4) lethality.
Measured: Pre-intervention, Post-intervention (Up to six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorian Lamis, Emory University
- Investigators
- Dorian Lamis, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604277
- Sponsor's protocol ID
- IRB00084800
- Other IDs
- 2025P010887
- Status last verified
- Jan 2026
- First submitted
- 10 Nov 2015
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32579284
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors
- ClinicalTrials.gov ID
- NCT02604277
- Acronym / sponsor ID
- IRB00084800
- Conditions
- Depression, Alcoholism, Drug Abuse
- Keywords
- Psychology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Intervention Program | Experimental | 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 TherapyPatients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking
- Diagnosis of Bipolar Disorder (BD)
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Cognitive impairments
- Acutely psychotic
- Medically unstable
- History of schizophrenia spectrum disorder
- History of mood incongruent psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group Intervention Program |
| 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. | Behavioural | Group Intervention Program |
| 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. | Behavioural | Group Intervention Program |
| Psycho-education & Understanding Bipolar Medications TherapyPsycho-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 | Behavioural | Group Intervention Program |
Primary outcome
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Pre-intervention, Post-intervention (Up to six weeks)
Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) serves 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 C-SSRS has four constructs relevant to recent suicidal ideation (SI): 1) severity (1=wish to be dead, 2=nonspecific active suicidal thoughts, 3=suicidal thoughts with methods, 4=suicidal intent, and 5=suicidal intent with plan); 2) intensity (sum across six items each rated 0 to 5: most severe ideation, frequency, duration, controllability, deterrents, and reason); 3) behavior; and 4) lethality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 32579284Au 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorian Lamis, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Alcoholism, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorian Lamis, PhD ((404) 616-3533, dorian.lamis@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia-Suicide Severity Rating Scale (C-SSRS) Score (time frame: Pre-intervention, Post-intervention (Up to six weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.