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Clinical Trials/NCT02129790
NCT02129790
Completed
Not Applicable

Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder

University of California, Los Angeles1 site in 1 country10 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
University of California, Los Angeles
Enrollment
10
Locations
1
Primary Endpoint
Self-harm Scores
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
September 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David J. Miklowitz, Ph.D.

Professor of Psychiatry

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified
  • Living with or in close contact with at least one parent who is willing to participate
  • Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake.
  • Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic

Exclusion Criteria

  • Participants requiring immediate hospitalization
  • Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder.
  • Current substance dependence disorder

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Depression scores(every 3 months for 9 months)
  • Treatment completion(first 6 study months)

Study Sites (1)

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