12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder

NCT04283188 | Completed DMC

• 2 other identifiers: 447-2019151/2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Disorder

Keywords

Dialectical behavior therapy

Outcome Measures

Primary Outcomes (45)

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 6 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  18 months

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 6 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  24 months

• Therapists will adhere to the Dialectical Behavior Therapy Adherence Rating Scale

  Tapes will be rated for adherence using the Dialectical Behavior Therapy (DBT) Adherence Rating scale. The scale generates a Global Score of DBT adherence and subscale scores for the 12 DBT strategy domains. To examine sustained adherence, each therapist will submit 3 consecutive sessions for adherence coding. The rating scale is not available to the public and is utilized by the DBT-Linehan Board of Certification (copyright). Please see http://www.dbt-lbc.org/downloads/Applicant\_Handbook\_final\_with\_RW\_review\_2018.pdf for more information.

  Through study completion (three years), an average of semi-annually.

• Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)

  The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.

  12 months to 18 months

• Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)

  The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.

  18 months to 24 months

• Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)

  Parent and adolescent reported depressive and manic symptoms will be measured via the Child Mania Rating Scale (CMRS). The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale with scores ranging from 0 to 3. High scores indicate higher level of symptoms.

  12 months to 15 months

• Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)

  Parent and adolescent reported depressive and manic symptoms will be measured via the Child Mania Rating Scale (CMRS). The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale with scores ranging from 0 to 3. High scores indicate higher level of symptoms.

  15 months to 18 months

• Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)

  Parent and adolescent reported depressive and manic symptoms will be measured via the Child Mania Rating Scale (CMRS). The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale with scores ranging from 0 to 3. High scores indicate higher level of symptoms.

  18 months to 121 months

• Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)

  Parent and adolescent reported depressive and manic symptoms will be measured via the Child Mania Rating Scale (CMRS). The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale with scores ranging from 0 to 3. High scores indicate higher level of symptoms.

  21 months to 24 months

• Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

  We will assess suicidal events (past and over follow-up) with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.

  12 months to 18 months

• Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

  We will assess suicidal events (past and over follow-up) with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.

  18 months to 24 months

• Change in symptoms using the Mood and Feelings Questionnaire (MFQ)

  Self-reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  12 months to 15 months

• Change in symptoms using the Mood and Feelings Questionnaire (MFQ)

  Self-reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  15 months to 18 months

• Change in symptoms using the Mood and Feelings Questionnaire (MFQ)

  Self-reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  18 months to 21 months

• Change in symptoms using the Mood and Feelings Questionnaire (MFQ)

  Self-reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  21 months to 24 months

• Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)

  Adolescents will also complete the self-report Suicidal Ideation (SIQ), which is intended to identify adolescents whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the adolescent experiences each thought.

  12 months to 15 months

• Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)

  Adolescents will also complete the self-report Suicidal Ideation (SIQ), which is intended to identify adolescents whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the adolescent experiences each thought.

  15 months to 18 months

• Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)

  Adolescents will also complete the self-report Suicidal Ideation (SIQ), which is intended to identify adolescents whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the adolescent experiences each thought.

  18 months to 21 months

• Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)

  Adolescents will also complete the self-report Suicidal Ideation (SIQ), which is intended to identify adolescents whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the adolescent experiences each thought.

  21 months to 24 months

• Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)

  Adolescents will also complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".

  12 months to 15 months

• Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)

  Adolescents will also complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".

  15 months to 18 months

• Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)

  Adolescents will also complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".

  18 months to 21 months

• Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)

  Adolescents will also complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".

  21 months to 24 months

• Treatment Satisfaction Questionnaire (18-item)

  Following the year-long DBT intervention, patients and parents will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.

  15 months

• Treatment Satisfaction Questionnaire (18-item)

  Following the year-long DBT intervention, patients and parents will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.

  18 months

• Treatment Satisfaction Questionnaire (18-item)

  Following the year-long DBT intervention, patients and parents will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.

  21 months

• Treatment Satisfaction Questionnaire (18-item)

  Following the year-long DBT intervention, patients and parents will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.

  24 months

• Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder

  Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.

  12 months to 18 months

• Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder

  Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.

  18 months to 24 months

• Change in affective lability using the Children's Affective Lability Scale (CALS)

  The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor.

  12 months to 15 months

• Change in affective lability using the Children's Affective Lability Scale (CALS)

  The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Item scores range from 0 to 4 and higher scores indicate higher affective lability.

  15 months to 18 months

• Change in affective lability using the Children's Affective Lability Scale (CALS)

  The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Item scores range from 0 to 4 and higher scores indicate higher affective lability.

  18 months to 21 months

• Change in affective lability using the Children's Affective Lability Scale (CALS)

  The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Item scores range from 0 to 4 and higher scores indicate higher affective lability.

  21 months to 24 months

• Dialectical Behavior Therapy Barriers to Implementation

  The Dialectical Behavior Therapy Barriers to Implementation (DBT-BTI) is a 26-item self-report survey that assesses barriers to DBT implementation in four domains: team, direction/motivation, theoretical position/philosophy, and administrative/structural problems. It is a yes/no questionnaire and higher scores indicate higher challenges in implementation. To be completed by DBT therapist participants.

  12 months to 18 months

• Dialectical Behavior Therapy Barriers to Implementation

  The Dialectical Behavior Therapy Barriers to Implementation (DBT-BTI) is a 26-item self-report survey that assesses barriers to DBT implementation in four domains: team, direction/motivation, theoretical position/philosophy, and administrative/structural problems. It is a yes/no questionnaire and higher scores indicate higher challenges in implementation. To be completed by DBT therapist participants.

  18 months to 24 months

• Barriers and Facilitators Assessment Instrument (name of scale)

  Therapists will complete this well-validated and widely used measure, and is the only measure available that is designed to assess barriers and facilitators at each of the levels proposed within one instrument.

  12 months to 18 months

• Barriers and Facilitators Assessment Instrument (name of scale)

  Therapists will complete the Barriers and Facilitators Assessment Instrument which is a well-validated and widely used measure, and is the only measure available that is designed to assess barriers and facilitators at each of the levels proposed within one instrument. It is a 16 item Likert scale questionnaire ranging from 1 to 6 with some items being reverse scored. High scores generally indicate challenges to implementation.

  18 months to 24 months

• Implementation Climate Scale

  The Implementation Climate Scale will enable the team to document relevant organizational processes the aid in implementation of this treatment and provide a context for other evidence-based treatment dissemination studies. This is a Likert scale from 0 to 4 with low scores indicating challenges with implementation.

  12 months to 18 months

• Implementation Climate Scale

  The Implementation Climate Scale will enable the team to document relevant organizational processes the aid in implementation of this treatment and provide a context for other evidence-based treatment dissemination studies. This is a Likert scale from 0 to 4 with low scores indicating challenges with implementation.

  18 months to 24 months

• Change in therapist self-assessment

  The Dialectical Behavior Therapy (DBT) Therapist Self-Assessment will allow for DBT therapists to provide subjective appraisals of their own level of comfort and confidence in applying the treatment. It also assesses the need for additional supervision from the study supervisor, consultant, and/or peer. Scores range from 1 to 7 on a Likert scale and high scores indicate high therapist level of comfort in implementing the treatment.

  Every month for three years through study completion, an average of 36 months.

• Number of therapy sessions

  The DBT Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the DBT study therapist after each therapy session.

  At the end of study completion (three years)

• Frequency of therapy sessions

  The DBT Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the DBT study therapist after each therapy session.

  At the end of study completion (three years)

• Type of therapy sessions

  The DBT Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the DBT study therapist after each therapy session.

  At the end of study completion (three years)

• Reasons for continuing or not continuing in treatment

  Participants and study therapists will be asked to complete the Dialectical Behavior Therapy Continuation Questionnaire to assess reasons for continuing or not continuing to proceed with the DBT treatment. Items are rated from 1 (strongly disagree) to 7 (strongly agree)

  12 months

• Change in number of hours of supervision

  The Therapist Supervision Hours Log will be completed by the DBT study therapist for all supervision received on study cases. This form includes date of supervision, duration of supervision, and type of supervision.

  At the end of study completion (three years)

Study Arms (1)

Adolescents with bipolar disorder

EXPERIMENTAL

25 adolescents aged 14 to 21 with bipolar disorder (type I, type II, not otherwise specified/nos) will be enrolled in the dialectical behavioral therapy intervention.

Behavioral: Dialectical behavioral therapy

Interventions

Dialectical behavioral therapy BEHAVIORAL

Participants will be provided with the option to continue treatment with their study therapist. For those who elect to continue with DBT sessions, they will discuss frequency of sessions with their therapist, in addition to selecting type of sessions (individual and/or family skills). Participants who elect not to continue with DBT sessions at the time of enrollment will retain the option of being able to request additional sessions at any point during the 12-month study. Irrespective of participation in additional DBT sessions, all participants will be asked to complete follow-up interviews and questionnaires.

Also known as: DBT

Adolescents with bipolar disorder

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University of Pittsburgh: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Benjamin I Goldstein, MD, PhD

  Sunnybrook Research Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Centre for Youth Bipolar Disorder, Senior Scientist, Psychiatrist, Principal Investigator, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: February 19, 2020
• Primary Completion: November 18, 2022
• Study Completion: January 13, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)