Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 3:23 PM
Ignite Modification Date: 2025-12-24 @ 3:23 PM
NCT ID: NCT05627492
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.
Study: NCT05627492
Study Brief:
Protocol Section: NCT05627492