Bipolar DisorderNCT03661333
Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
A study testing Dialectical behavioral therapy in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Dialectical behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2019to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Bipolar Disorder
- Being tested
- Dialectical behavioral therapy
- Keywords
- dialectical behavior therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioral therapyBehavioural
Also called DBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with bipolar disorder | Experimental | 40 adolescents aged 13 to 19 with bipolar disorder (type I, type II, not otherwise specified/nos) will be enrolled in the dialectical behavioral therapy intervention. Receives: Behavioral: Dialectical behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Baseline
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").
Measured: 6 months
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.
Measured: End of study year 2
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.
Measured: 1 year
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").
Measured: 12 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 24 months. Acceptability will be defined as mean acceptability ratings > 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").
Measured: 24 months
Secondary outcomes (42)
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.
Measured: Baseline to 6 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.
Measured: 6 months to 12 months
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline to 3 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 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.
Measured: 3 months to 6 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 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.
Measured: 6 months to 9 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 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.
Measured: 9 months to 12 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 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.
Measured: Baseline to 6 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 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.
Measured: 6 months to 12 months
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").
Measured: Baseline to 3 months,
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").
Measured: 3 months to 6 months
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").
Measured: 6 months to 9 months
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").
Measured: 9 months to 12 months
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.
Measured: Baseline to 3 months
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.
Measured: 3 months to 6 months
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.
Measured: 6 months to 9 months
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.
Measured: 9 months to 12 months
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%".
Measured: Baseline to 3 months
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%".
Measured: 3 months to 6 months
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%".
Measured: 6 months to 9 months
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%".
Measured: 9 months to 12 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.
Measured: 12 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.
Measured: 3 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.
Measured: 6 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.
Measured: Baseline to 6 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.
Measured: 6 months to 12 months
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.
Measured: Baseline to 3 months
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.
Measured: 3 months to 6 months
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.
Measured: 6 months to 9 months
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.
Measured: 9 months to 12 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.
Measured: Baseline to 6 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.
Measured: 6 months to 12 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.
Measured: 12 months to 24 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.
Measured: Baseline to 6 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.
Measured: 6 months to 12 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.
Measured: 12 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.
Measured: Baseline to 6 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.
Measured: 6 months to 12 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.
Measured: 12 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.
Measured: Every month for two years through study completion, an average 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start31 Jan 2019
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
- Investigators
- Benjamin I Goldstein, MD, PhD, Principal investigator, Sunnybrook Research Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661333
- Sponsor's protocol ID
- 042-2018
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2018
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldstein TR, Dimick MK, Hotkowski N, Chugani C, Curcio D, Roane J, Timmins V, Mitchell R, Rode N, Khoubaeva D, Kolko D, Goldstein BI. An implementation "Field Trial" of DBT for adolescents with bipolar disorder: Training procedures and therapist outcomes. J Affect Disord. 2026 Nov 15;413:122211. doi: 10.1016/j.jad.2026.122211. Epub 2026 Jul 3.
PubMed 42398677
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03661333
- Acronym / sponsor ID
- 042-2018
- Conditions
- Bipolar Disorder
- Keywords
- dialectical behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with bipolar disorder | Experimental | Behavioral: Dialectical behavioral therapy40 adolescents aged 13 to 19 with bipolar disorder (type I, type II, not otherwise specified/nos) will be enrolled in the dialectical behavioral therapy intervention. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavioral therapyAlso: DBTDBT 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. | Behavioural | Adolescents with bipolar disorder |
Primary outcome
Therapist satisfaction and acceptability
Time frame: Baseline
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").
Therapist satisfaction and acceptability
Time frame: 6 months
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").
therapists will adhere to the DBT Adherence Rating Scale
Time frame: End of study year 2
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.
Therapists will obtain a passing grade of the DBT Certification Exam
Time frame: 1 year
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.
Therapist satisfaction and acceptability
Time frame: 12 months
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").
Therapist satisfaction and acceptability
Time frame: 24 months
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").
42 secondary outcomes
Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
Time frame: Baseline to 6 months
Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
Time frame: 6 months to 12 months
Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)
Time frame: Baseline
K-SADS Mania Rating Scale (MRS)
Time frame: Baseline
Depression section of the K-SADS-Present Episode Version (K-SADS-Dep)
Time frame: Baseline
Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
Time frame: Baseline to 3 months
Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
Time frame: 3 months to 6 months
Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
Time frame: 6 months to 9 months
Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
Time frame: 9 months to 12 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to 6 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months to 12 months
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Time frame: Baseline to 3 months,
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Time frame: 3 months to 6 months
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Time frame: 6 months to 9 months
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Time frame: 9 months to 12 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: Baseline to 3 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 3 months to 6 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 6 months to 9 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 9 months to 12 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline to 3 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 3 months to 6 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 6 months to 9 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 9 months to 12 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 12 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 3 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 6 months
Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
Time frame: Baseline to 6 months
Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
Time frame: 6 months to 12 months
Change in affective lability using the Children's Affective Lability Scale (CALS)
Time frame: Baseline to 3 months
Change in affective lability using the Children's Affective Lability Scale (CALS)
Time frame: 3 months to 6 months
Change in affective lability using the Children's Affective Lability Scale (CALS)
Time frame: 6 months to 9 months
Change in affective lability using the Children's Affective Lability Scale (CALS)
Time frame: 9 months to 12 months
Dialectical Behavior Therapy Barriers to Implementation
Time frame: Baseline to 6 months
Dialectical Behavior Therapy Barriers to Implementation
Time frame: 6 months to 12 months
Dialectical Behavior Therapy Barriers to Implementation
Time frame: 12 months to 24 months
Barriers and Facilitators Assessment Instrument (name of scale)
Time frame: Baseline to 6 months
Barriers and Facilitators Assessment Instrument (name of scale)
Time frame: 6 months to 12 months
Barriers and Facilitators Assessment Instrument (name of scale)
Time frame: 12 months to 24 months
Implementation Climate Scale
Time frame: Baseline to 6 months
Implementation Climate Scale
Time frame: 6 months to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 42398677Goldstein TR, Dimick MK, Hotkowski N, Chugani C, Curcio D, Roane J, Timmins V, Mitchell R, Rode N, Khoubaeva D, Kolko D, Goldstein BI. An implementation "Field Trial" of DBT for adolescents with bipolar disorder: Training procedures and therapist outcomes. J Affect Disord. 2026 Nov 15;413:122211. doi: 10.1016/j.jad.2026.122211. Epub 2026 Jul 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin I Goldstein, MD, PhD principal investigator
Sunnybrook Research Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioral therapy in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapist satisfaction and acceptability (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.