Clinical trial NCT05627492: Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
Official title: Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Youth
Dialectical Behavior Therapy (DBT)
Suicide
Psychotherapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria

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

1. Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
2. English speaking;
3. Age 14 years, 0 months to 26 years, 11 months;
4. 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;
5. Followed by a psychiatrist who provides ongoing care;
6. If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
7. 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:

1. A life-threatening medical condition requiring immediate treatment;
2. Current victim of sexual or physical abuse;
3. Current substance use disorder other than mild cannabis or alcohol use disorder;
4. 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.

Primary outcomes:
measure: Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form
timeFrame: At the end of study completion (five years)
measure: Number of unscheduled/expedited DBT sessions that are required measured using the Therapy
timeFrame: At the end of study completion (five years)
measure: Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy
timeFrame: At the end of study completion (five years)
Secondary outcomes:
measure: Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
timeFrame: At the end of study completion (five years)
measure: Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form
timeFrame: At the end of study completion (five years)
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 18 months to 24 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 12 months to 15 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 15 months to 18 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 18 months to 21 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 21 months to 24 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 18 months to 24 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 months to 18 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 18 months to 24 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 12 months to 15 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 15 months to 18 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 18 months to 21 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 21 months to 24 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 15 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 18 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 21 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 24 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 12 months to 15 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 15 months to 18 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 18 months to 21 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 21 months to 24 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 12 months to 15 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 15 months to 18 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 18 months to 21 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 21 months to 24 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 24 months to 30 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 30 months to 36 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 24 months to 27 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 27 months to 30 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 30 months to 33 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 33 months to 36 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 24 months to 30 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 30 months to 36 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 24 months to 30 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 30 months to 36 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 24 months to 27 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 27 months to 30 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 30 months to 33 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 33 months to 36 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 24 months to 27 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 27 months to 30 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 30 months to 33 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 33 months to 36 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 24 months to 27 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 27 months to 30 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 30 months to 33 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 33 months to 36 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 24 months to 27 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 27 months to 30 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 30 months to 33 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 33 months to 36 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: