About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
English speaking;
Age 14 years, 0 months to 26 years, 11 months;
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;
Disqualifiers
A life-threatening medical condition requiring immediate treatment;
Current victim of sexual or physical abuse;
Current substance use disorder other than mild cannabis or alcohol use disorder;
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
Single group
Treatments tested in this trial
Dialectical behavioral therapy
BehavioralDBT will be conducted over 1 year. 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.
Treatment groups
Trial outcomes
Primary outcomes
Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form
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.
Number of unscheduled/expedited DBT sessions that are required measured using the Therapy
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.
Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy
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
Video recordings will be rated for adherence using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy (DBT AC-I) \[54\]. The 12 DBT strategy domains will be rated as yes/no: 1) structural strategies; 2) problem assessment strategies; 3) problem solving strategies; 4) contingency management strategies; 5) exposure strategies; 6) cognitive modification strategies; 7) validation strategies; 8) reciprocal communication strategies; 9) irreverent communication strategies; 10) dialectical strategies; 11) case management strategies; 12) protocols.
Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form
The Therapy Tracking Form will be used to document the type of therapy session and phone coaching use. This form will be completed by the study therapist after each therapy session.
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
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