NCT05627492

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 14 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
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 sessions. Family participation in skills training is highly encouraged. Skills training may include: psychoeducation, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the youth in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets.

Timeline

• Start date: 2022-11-09
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2022-11-25
• Last updated: 2025-11-19

Locations

1 site across 1 country: Canada