Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder (DB2)

Center for Addiction and Mental Health (CAMH)

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Behavioral: Dialectical behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05627492

099/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Youth with and/or at familial risk for bipolar disorder

Experimental group

Description:

120 youth aged 14 to 26 with bipolar disorder (type I, type II, not otherwise specified/NOS via KSADS-PL or SCID-5-RV) OR at high-risk for bipolar disorder (parent or sibling with bipolar disorder type I or II via KSADS-PL or SCID-5-RV) will be enrolled in the dialectical behavioral therapy booster session intervention.

Treatment:

Behavioral: Dialectical behavioral therapy