Clinical trial NCT02129790: Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
Official title: Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Suicidal Ideation
Keywords: Bipolar Disorder
Suicidal
Depression
Self-harm
Psychosocial intervention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2014-05-02
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-harm Scores
timeFrame: measured every 3 months for 9 months
Secondary outcomes:
measure: Treatment completion
timeFrame: first 6 study months
measure: Depression scores
timeFrame: every 3 months for 9 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: UCLA Department of Psychiatry
name: David J Miklowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miklowitz DJ, Taylor DO. Family-focused treatment of the suicidal bipolar patient. Bipolar Disord. 2006 Oct;8(5 Pt 2):640-51. doi: 10.1111/j.1399-5618.2006.00320.x.
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.