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

Centre for Addiction and Mental Health1 site in 1 country120 target enrollmentNovember 9, 2022

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 9, 2022

End Date

November 30, 2028

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre for Addiction and Mental Health

Responsible Party

Principal Investigator

Benjamin Goldstein

Director of the Centre for Youth Bipolar Disorder, Clinician-Scientist, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Centre for Addiction and Mental Health

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of unscheduled/expedited DBT sessions that are required measured using the Therapy

Time Frame: At the end of study completion (five years)

The Therapy Tracking Form will be used to document if the session was a scheduled session or an unscheduled/expedited session. This form will be completed by the study therapist after each therapy session.

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)

The Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the study therapist after each therapy session.

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)

The Therapy Tracking Form will be used to document the reason for the unscheduled/expedited DBT session. This form will be completed by the study therapist after each therapy session.

Secondary Outcomes

Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy(At the end of study completion (five years))
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)(30 months to 36 months)
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder(30 months to 36 months)
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)(33 months to 36 months)
Change in temperament using the Conflict Behavior Questionnaire (CBQ)(33 months to 36 months)
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)(30 months to 36 months)
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)(33 months to 36 months)
Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form(At the end of study completion (five years))
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)(33 months to 36 months)
Treatment Satisfaction Questionnaire (18-item)(33 months to 36 months)