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Recruiting NCT05627492

Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

No phase Interventional Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dialectical behavioral therapy.
Who it may be relevant to
Registry conditions: Bipolar Disorder. Basic parameters: 14 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared.

Detailed description

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. DBT consists of four components: individual therapy sessions, skills sessions, skills coaching via phone, and consultation team. Given this study is an extension of an existing study of full DBT, the proposed intervention is not prescriptive; that is, we have opted not to dictate how many sessions participants will receive and/or when. Instead, we have opted to leave this decision for participants and their treatment providers to reach collaboratively. Participants, in consultation with their study therapist, will select the frequency of their booster sessions. This may include individual and/or skills sessions in addition to phone coaching for those who attend individual sessions at least once per month. DBT consultation will also remain a component of the treatment. This level of intervention seems appropriate, given that participants have completed a full year of DBT and thus may require a less intensive treatment for continued care. Moreover, it is important to give youth autonomy in treatment options to model health decision making for other life choices.

Interventions

  • Behavioral Dialectical behavioral therapy
    DBT will be conducted over 2 years. Participants and their treatment providers will decide on the frequency of sessions collaboratively. This may include individual and/or skills sessions in addition to phone coaching for those who attend individual sessions at least once per month. DBT consultation will also remain a component of the treatment. Participants may choose skills training, conducted in approximately 60 minute meetings, and individual therapy conducted in approximately 60 minute sess

Primary outcome measures

  • Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form [Time frame: At the end of study completion (five years)]
  • Number of unscheduled/expedited DBT sessions that are required measured using the Therapy [Time frame: At the end of study completion (five years)]
  • Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy [Time frame: At the end of study completion (five years)]
Secondary outcome measures (12)
  • Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy [Time frame: At the end of study completion (five years)]
  • Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form [Time frame: At the end of study completion (five years)]
  • 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 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: 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: 12 months to 18 months]
  • Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: 18 months to 24 months]

Eligibility criteria

Inclusion criteria

The participant must meet all of the inclusion criteria to eligible for this clinical trial:

  • Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
  • English speaking;
  • Age 14 years, 0 months to 26 years, 11 months;
  • Meets diagnostic criteria for bipolar disorder 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;
  • Followed by a psychiatrist who provides ongoing care;
  • If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
  • Able and willing to give informed consent/assent to participate.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this clinical trial:

  • A life-threatening medical condition requiring immediate treatment;
  • Current victim of sexual or physical abuse;
  • Current substance use disorder other than mild cannabis or alcohol use disorder;
  • Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records that would interfere with active participation in DBT.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Identifiers

NCT: NCT05627492 · 099/2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗