Clinical trial NCT04283188: 12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder
Official title: Pragmatic Patient-Oriented 12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Dialectical behavior therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Centre for Addiction and Mental Health
First posted: 2020-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to evaluate the longer-term effects of implementing DBT for adolescents with BD in a subspecialty clinic. In collaboration with the University of Pittsburgh and continuing from the parent study (042-2018), this study will measure the longer-term effects of DBT in additional the the longer-term effects of DBT training on study therapist knowledge and performance.

Detailed description: This is an extension study related to an ongoing implementation study of dialectical behavior therapy (DBT) for adolescents with bipolar disorder, in collaboration with investigators at the University of Pittsburgh. During the conduct of that initial study (the DITO study; REB PIN 042-2018), compelling questions have been raised by the investigators, study therapists, and participants/patients about what will happen following participation in the initial study: Which DBT outcomes are sustained over time? Will patients request and/or require additional booster sessions? Will study therapists remain adherent to the treatment model? There is sparse knowledge regarding what happens after a course of DBT is completed, and this study seeks to advance our understanding of what happens in the year after DBT by addressing these questions. This study provides a unique opportunity to examine the frequency, dose, and indications for ongoing DBT treatment for participants who have completed one year of DBT at the Centre for Youth Bipolar Disorder (CYBD). In the spirit of the original dissemination and implementation study, this study is focused on "real-world" issues routinely faced by study therapists and patients, and anticipated findings will inform future randomized controlled trials on this topic.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age 14 years, 0 months to 21 years, 11 months
* Meet diagnostic criteria for BD by KSADS-PL
* Followed by a CAMH or Sunnybrook psychiatrist who provides ongoing care
* If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium
* Has completed participation in the DITO study (REB PIN 042-2018)
* Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

* Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
* A life-threatening medical condition requiring immediate treatment
* Current victim of sexual or physical abuse.

Primary outcomes:
measure: Therapist satisfaction and acceptability
timeFrame: 18 months
measure: Therapist satisfaction and acceptability
timeFrame: 24 months
measure: Therapists will adhere to the Dialectical Behavior Therapy Adherence Rating Scale
timeFrame: Through study completion (three years), an average of semi-annually.
measure: Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: 18 months to 24 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 12 months to 15 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 15 months to 18 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 18 months to 121 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 21 months to 24 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 months to 18 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 18 months to 24 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 12 months to 15 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 15 months to 18 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 18 months to 21 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 21 months to 24 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 12 months to 15 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 15 months to 18 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 18 months to 21 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 21 months to 24 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 12 months to 15 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 15 months to 18 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 18 months to 21 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 21 months to 24 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 15 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 18 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 21 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 24 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
timeFrame: 18 months to 24 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 12 months to 15 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 15 months to 18 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 18 months to 21 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 21 months to 24 months
measure: Dialectical Behavior Therapy Barriers to Implementation
timeFrame: 12 months to 18 months
measure: Dialectical Behavior Therapy Barriers to Implementation
timeFrame: 18 months to 24 months
measure: Barriers and Facilitators Assessment Instrument (name of scale)
timeFrame: 12 months to 18 months
measure: Barriers and Facilitators Assessment Instrument (name of scale)
timeFrame: 18 months to 24 months
measure: Implementation Climate Scale
timeFrame: 12 months to 18 months
measure: Implementation Climate Scale
timeFrame: 18 months to 24 months
measure: Change in therapist self-assessment
timeFrame: Every month for three years through study completion, an average of 36 months.
measure: Number of therapy sessions
timeFrame: At the end of study completion (three years)
measure: Frequency of therapy sessions
timeFrame: At the end of study completion (three years)
measure: Type of therapy sessions
timeFrame: At the end of study completion (three years)
measure: Reasons for continuing or not continuing in treatment
timeFrame: 12 months
measure: Change in number of hours of supervision
timeFrame: At the end of study completion (three years)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Sunnybrook Research Insitute
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: