Recruiting

DBT-informed Care

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05153369

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 13 - 23

Healthy Volunteers: Not accepted

Interventions

Enhanced Care

DBT Skills Training

Dialectical Behavior Therapy Full Intervention

Study Details

Brief summary:

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

Conditions

Bipolar Disorder

Study ID

NCT05153369

Start date

Nov 1, 2021

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 23

Healthy Volunteers: Not accepted

Inclusion Criteria:

1\) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD by KSADS-PL (< 20 years of age) or SCID-5-RV (≥ 20 years of age) OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6) Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

1\) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder; 5) Meets assessment criteria for Level 3 at enrollment.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Level 1

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No lifetime suicidal behaviors on the Columbia-Suicide Severity Rating Scale (C-SSRS) AND no active suicidal ideations with method/plan/intent in the past month on the C-SSRS (cannot score 'yes' on items > 3).

experimental: Level 2

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No non-suicidal self-injurious (NSSI) behaviors in the past 3 months on the C-SSRS AND no suicide attempts (actual, interrupted and/or aborted) in the past year on the C-SSRS AND no preparatory act or behavior in the past year as measured by the C-SSRS OR participant preference.

experimental: Level 3

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: NSSI behaviors in the past 3 months on the C-SSRS OR at least 1 suicide attempt in the past year (actual, interrupted, and/or aborted) on the C-SSRS OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR Meets youth threshold for at least 2 impulsive behavior categories on question #4 from the Structured Interview for DSM-IV Personality Disorders Borderline Personality Disorder (SIDP-IV) or 1 category is identified as severe OR participant preference during the course of treatment.

Interventions

Enhanced Care

Enhanced care aims to educate participants about bipolar disorder using a didactic approach, in addition to teaching and practicing DBT skills in an applied and relevant manner based on the participant's needs. Participants will receive a total of four sessions (approx. 60 minutes in duration), to occur once a month, at a minimum. The content will be split up into psychoeducation (2 sessions) and selected DBT skills (2 sessions). Psychoeducation will be specific to youth bipolar disorder, covering topics such as symptoms of depression and hypo/mania, medications used to treat bipolar disorder, the role of biology and the environment in emotions, and vulnerability and protective factors to emotion dysregulation and mood episodes. The content of skills sessions will be individualized and based on participant needs and goals (e.g., learning and applying skills to optimize their overall functioning, address problem behaviors and/or stressors, and/or maintain commitment to treatment).

DBT Skills Training

In DBT Skills Training, participants will only receive skills training and can choose to do this individually and/or with their individual family unit by including their parent(s) and/or sibling(s). Participants will receive 20-25 sessions (approx. 60 minutes in duration), to occur at least biweekly. Skills training will include the five standard youth DBT modules: psychoeducation about DBT and bipolar disorder, mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness, and walking the middle path. The primary focus of the skills training is to impart knowledge and acquire and strengthen pragmatic skills to replace dysfunctional behaviors. If participants choose to include their family members, they will be encouraged to coach one another in effective use of skills.

Dialectical Behavior Therapy Full Intervention

The DBT full intervention is based on Miller et al.'s DBT for suicidal youth, with modifications for youth with BD. DBT will be conducted over 1 year with approximately 40-50 sessions. Sessions will alternate between individual and skills training sessions. Family involvement in skills training will be strongly encouraged, however will be up to the participant to decide. Participants in Level 3 will complete diary cards tailored for this population, assessing daily mood, suicidality, sleep, and medication adherence. Participants will report use of specified DBT skills on the diary card, and individualized treatment goals will be incorporated into the diary card (e.g., alcohol use). In addition, Level 3 will include skills coaching by phone (via phone and/or text). These brief, structured calls and/or texts function to promote skills generalization by helping the participant and any participating family member(s) use skills to achieve goals and solve problems.

Primary outcome measure

  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: Baseline to 6 months ]
  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 6 months to 12 months ]
  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 12 months to 18 months ]
  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 18 months to 24 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 symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 12 months to 15 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 15 months to 18 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 18 months to 21 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 21 months to 24 months ]
  • Change in suicidality 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 suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 12 months to 15 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 15 months to 18 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 18 months to 21 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 21 months to 24 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: Baseline to 6 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 6 months to 12 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 12 months to 18 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 18 months to 24 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 suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 months to 18 months ]
  • Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 18 months to 24 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 ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 12 months to 15 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 15 months to 18 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 18 months to 21 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 21 months to 24 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 3 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 6 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 9 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 12 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 15 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 18 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 21 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 24 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 ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 12 months to 15 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 15 months to 18 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 18 months to 21 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 21 months to 24 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: Baseline to 3 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 3 months to 6 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 6 months to 9 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 9 months to 12 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 12 months to 15 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 15 months to 18 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 18 months to 21 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 21 months to 24 months ]
  • Childhood Trust Events Survey (CTES) [ Time Frame: Baseline ]
  • Number, frequency, and type of therapy sessions [ Time Frame: At the end of study completion (5 years) ]

Central Contacts and Locations

Central contacts

Amanda Moss, MSW

416-535-8501amanda.moss@camh.ca

Danielle Curcio, MSW

416-535-8501danielle.curcio@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Amanda Moss, MSW

416-535-8501amanda.moss@camh.ca

Vanessa Rajamani, MSW

416-535-8501vanessa.rajamani@camh.ca

Principal Investigator:

Benjamin I Goldstein, MD, PhD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Youth
  • Dialectical Behavior Therapy (DBT)
  • Psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.