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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129790
• Other study ID #: 13-000988
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

Miklowitz DJ, Taylor DO. Family-focused treatment of the suicidal bipolar patient. Bipolar Disord. 2006 Oct;8(5 Pt 2):640-51. Review. — View Citation

Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-harm Scores	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.	measured every 3 months for 9 months
Secondary	Treatment completion	Treatment completion will be measured by number of sessions attended and number of patients who drop out of treatment before six months.	first 6 study months
Secondary	Depression scores	Depression is a total score drawn from the Kiddie Schedule for Affective Disorders and Schizophrenia, Depression Rating Scale	every 3 months for 9 months

External Links

•   UCLA Child and Adolescent Mood Disorders Program