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Completed

NCT Number: NCT02129790

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

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.

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Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentalization-Based Therapy

Behavioral

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 2, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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