Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661333
• Other study ID #: 042-2018
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.

Description:

This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.

Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.

Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• English-speaking

• Age 13 years, 0 months to 19 years, 11 months

• Meet diagnostic criteria for BD by KSADS-PL

• Engaged in, or willing to proceed with, a pharmacotherapy regimen

• At least one parent/guardian with whom the patient lives or regularly interacts (>5 hours per week) is willing to participate in skills training

• 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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Dialectical behavioral therapy
DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants and their participating family members by cell phone for in-vivo skills coaching between sessions.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	University of Pittsburgh

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Baseline
Primary	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").	6 months
Primary	therapists will adhere to the DBT Adherence Rating Scale	Tapes will be rated for adherence using the 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.	End of study year 2
Primary	Therapists will obtain a passing grade of the DBT Certification Exam	Clinicians will attain knowledge and fidelity required to pass the DBT certification examination (exam total score = 80%; passing score on case conceptualization; two of three consecutive tapes coded at or above adherence). Please see the certification manual http://www.dbt-lbc.org/downloads/Applicant_Handbook_final_with_RW_review_2018.pdf for more information.	1 year
Primary	Therapist satisfaction and acceptability	Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 12 months. Acceptability will be defined as mean acceptability ratings > 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").	12 months
Primary	Therapist satisfaction and acceptability	Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 24 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
Secondary	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.	Baseline to 6 months
Secondary	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.	6 months to 12 months
Secondary	Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)	The K-SADS-PL is a semi-structured interview designed to ascertain present episode and lifetime history of psychiatric illness, according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for children and adolescents.	Baseline
Secondary	K-SADS Mania Rating Scale (MRS)	The K-SADS MRS is a 13-item rating scale with scores ranging from 0 to 6. In addition to assessing common manic symptoms, it includes the K-SADS-PL items that assess the presence and severity of hallucinations and delusions.	Baseline
Secondary	Depression section of the K-SADS-Present Episode Version (K-SADS-Dep)	The K-SADS-Dep will be used to assess the presence and severity of depressive symptoms. It is a 21-item semi-structured interview that allows depression symptom severity to be rated on a 6-point scale, from none to severe.	Baseline
Secondary	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 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.	Baseline to 3 months
Secondary	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 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.	3 months to 6 months
Secondary	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 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.	6 months to 9 months
Secondary	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 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.	9 months to 12 months
Secondary	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 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.	Baseline to 6 months
Secondary	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 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.	6 months to 12 months
Secondary	Change in symptoms using the Mood and Feelings Questionnaire (MFQ)	Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").	Baseline to 3 months,
Secondary	Change in symptoms using the Mood and Feelings Questionnaire (MFQ)	Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").	3 months to 6 months
Secondary	Change in symptoms using the Mood and Feelings Questionnaire (MFQ)	Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").	6 months to 9 months
Secondary	Change in symptoms using the Mood and Feelings Questionnaire (MFQ)	Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").	9 months to 12 months
Secondary	Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)	Adolescents will also complete the self-report 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.	Baseline to 3 months
Secondary	Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)	Adolescents will also complete the self-report 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.	3 months to 6 months
Secondary	Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)	Adolescents will also complete the self-report 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.	6 months to 9 months
Secondary	Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)	Adolescents will also complete the self-report 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.	9 months to 12 months
Secondary	Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)	Adolescents will also complete the 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%" to 5= "almost always; 91-100%".	Baseline to 3 months
Secondary	Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)	Adolescents will also complete the 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%" to 5= "almost always; 91-100%".	3 months to 6 months
Secondary	Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)	Adolescents will also complete the 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%" to 5= "almost always; 91-100%".	6 months to 9 months
Secondary	Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)	Adolescents will also complete the 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%" to 5= "almost always; 91-100%".	9 months to 12 months
Secondary	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.	12 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	Baseline to 6 months
Secondary	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.	6 months to 12 months
Secondary	Change in affective lability using the Children's Affective Lability Scale (CALS)	The 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.	Baseline to 3 months
Secondary	Change in affective lability using the Children's Affective Lability Scale (CALS)	The 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.	3 months to 6 months
Secondary	Change in affective lability using the Children's Affective Lability Scale (CALS)	The 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.	6 months to 9 months
Secondary	Change in affective lability using the Children's Affective Lability Scale (CALS)	The 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.	9 months to 12 months
Secondary	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.	Baseline to 6 months
Secondary	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.	6 months to 12 months
Secondary	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 24 months
Secondary	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.	Baseline to 6 months
Secondary	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.	6 months to 12 months
Secondary	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.	12 months to 24 months
Secondary	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.	Baseline to 6 months
Secondary	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.	6 months to 12 months
Secondary	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 24 months
Secondary	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 two years through study completion, an average 24 months.