Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Diagnosis of Bipolar Disorder (BD)
Able to provide written informed consent
Disqualifiers
Cognitive impairments
Acutely psychotic
Medically unstable
History of schizophrenia spectrum disorder
Trial design
Design model
Single group
Treatments tested in this trial
Interpersonal and Social Rhythm Therapy (ISRT)
BehavioralInterpersonal 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)
BehavioralBipolar-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)
BehavioralMindfulness-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
BehavioralPsycho-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
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: Group Intervention ProgramExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-intervention, Post-intervention (Up to six weeks)Other outcomes
1
Alcohol Use Disorders Identification Test (AUDIT) Score
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item measure designed to identify individuals whose alcohol use places them at risk for alcohol-related problems, or who are actually experiencing such problems. The AUDIT assesses frequency of drinking, dependence symptoms, and signs of harmful consumption, each on a four point scale, providing a total score between 0 and 40. A score of 0 indicates that the respondent has never had problems from alcohol, sores of 1 to 7 indicate low-risk consumption of alcohol, scores of 8 to 14 suggest harmful consumption of alcohol, and scores of 15 or more indicate moderate-severe alcohol use disorder.
Time frame
Pre-intervention, Post-intervention (Up to six weeks)2
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.
Time frame
Pre-intervention, Post-intervention (Up to six weeks)3
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.
Time frame
Pre-intervention, Post-intervention (Up to six weeks)4
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.
Time frame
Pre-intervention, Post-intervention (Up to six weeks)Sponsors and contacts
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Source ClinicalTrials.gov