Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT02129790|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Suicidal Ideation||Behavioral: Mentalization-Based Therapy||Not Applicable|
Youth with early-onset bipolar disorder (BD) are at an elevated risk for intentional self-harm compared to healthy adolescents or adolescents with other psychiatric disorders. Adolescents vulnerable to emotion dysregulation and self-harm often have deficits in the ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others. Mentalization-based therapy for adolescents (MBT-A) has been shown to be more effective than 'usual care' in reducing self-harm for adolescents and adults with borderline personality disorder. MBT-A includes psychoeducational and coping strategies that may prove quite effective for bipolar adolescents who are at elevated risk for self-harm.
Participation in this study will last 9 months. All participants will receive a thorough medical-psychiatric evaluation. All youth will be able to receive pharmacotherapy with a study psychiatrist in the CHAMP clinic. The MBT-A will consist of up to 21 weekly, biweekly and monthly individual sessions interspersed with 9 monthly family sessions (30 therapy hours total). Participants will also complete follow-up assessments every 3 months for 9 months. These assessments will include research interviews and questionnaires.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||September 1, 2018|
Experimental: Mentalization-Based Therapy
Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A will include psychoeducation and coping strategies.
Behavioral: Mentalization-Based Therapy
Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A sessions will focus on the adolescent's recent social experiences and the resulting mental states and managing interpersonal challenges, particularly those involving separation or loss. The goal of this intervention is to improve the adolescent's ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others.
- Self-harm Scores [ Time Frame: measured every 3 months for 9 months ]Self-harm is a composite score derived from two Kiddie Schedule for Affective Disorders and Schizophrenia Depression Rating Scale items, total scores on the Harkavy-Asnis Suicide Scale, total scores on the Risk and Self-Harm Scale, and specific levels of ideation or behavior on the Columbia Suicide and Self-Harm Scale.
- Treatment completion [ Time Frame: first 6 study months ]Treatment completion will be measured by number of sessions attended and number of patients who drop out of treatment before six months.
- Depression scores [ Time Frame: every 3 months for 9 months ]Depression is a total score drawn from the Kiddie Schedule for Affective Disorders and Schizophrenia, Depression Rating Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129790
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||David J Miklowitz, Ph.D.||UCLA Department of Psychiatry|