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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
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Suicidal Ideation Behavioral: Mentalization-Based Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
American Foundation for Suicide Prevention
Investigators
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Principal Investigator: David J Miklowitz, Ph.D. UCLA Department of Psychiatry

Additional Information:
Publications:
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Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02129790     History of Changes
Other Study ID Numbers: 13-000988
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Keywords provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
Bipolar Disorder
Suicidal
Depression
Self-harm
Psychosocial intervention

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Suicidal Ideation
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Behavioral Symptoms