Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
Primary Purpose
Bipolar Disorder, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentalization-Based Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Suicidal, Depression, Self-harm, Psychosocial intervention
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
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mentalization-Based Therapy
Arm Description
Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A will include psychoeducation and coping strategies.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Treatment completion
Treatment completion will be measured by number of sessions attended and number of patients who drop out of treatment before six months.
Depression scores
Depression is a total score drawn from the Kiddie Schedule for Affective Disorders and Schizophrenia, Depression Rating Scale
Full Information
NCT ID
NCT02129790
First Posted
April 25, 2014
Last Updated
April 16, 2019
Sponsor
University of California, Los Angeles
Collaborators
American Foundation for Suicide Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02129790
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
American Foundation for Suicide Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Suicidal Ideation
Keywords
Bipolar Disorder, Suicidal, Depression, Self-harm, Psychosocial intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mentalization-Based Therapy
Arm Type
Experimental
Arm Description
Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A will include psychoeducation and coping strategies.
Intervention Type
Behavioral
Intervention Name(s)
Mentalization-Based Therapy
Intervention Description
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 Measure Information:
Title
Self-harm Scores
Description
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.
Time Frame
measured every 3 months for 9 months
Secondary Outcome Measure Information:
Title
Treatment completion
Description
Treatment completion will be measured by number of sessions attended and number of patients who drop out of treatment before six months.
Time Frame
first 6 study months
Title
Depression scores
Description
Depression is a total score drawn from the Kiddie Schedule for Affective Disorders and Schizophrenia, Depression Rating Scale
Time Frame
every 3 months for 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Miklowitz, Ph.D.
Organizational Affiliation
UCLA Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17042836
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.
Results Reference
background
PubMed Identifier
23200287
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.
Results Reference
background
Links:
URL
http://www.semel.ucla.edu/champ
Description
UCLA Child and Adolescent Mood Disorders Program
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Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
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