Clinical trial NCT05153382: Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder
Official title: Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder: Focus on Predictors and Mediators of Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Youth
Dialectical Behavior Therapy (DBT)
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.

Detailed description: In recent years, studies led by investigators at the University of Pittsburgh have emerged that demonstrate the promise of adapting dialectical behavior therapy (DBT) to align with the unique needs of youth with bipolar disorder (BD). Our group has conducted a dissemination and implementation DBT study at Sunnybrook Health Sciences Centre focused specifically on youth with BD. Preliminary data from that study demonstrate that the study therapists, now at CAMH, have achieved fidelity and competence in delivering the intervention, as evidenced by adherence coding scores and participant outcomes. The DBT intervention is based on Miller et al.'s DBT for suicidal adolescents, with modifications for youth with BD. A co-investigator on this study, Dr. T. Goldstein, developed and refined the manualized treatment during her National Institute of Mental Health K23 award in consultation with Dr. Miller. In keeping with the protocol implemented in prior studies, DBT in the present study will be conducted over 1 year, and divided into two modalities: 1) DBT skills training (approximately 60 minute biweekly meetings); and 2) DBT individual therapy sessions (approximately 60 minute biweekly sessions) alternating with skills training. Family involvement in skills training will be strongly encouraged, but not mandatory. Master's level therapists with clinical experience in youth with BD and their families will conduct DBT. This study includes 1 year of assessments (intake, 3, 6, 9, and 12 months) while the intervention is being delivered. The target sample size will be 60 youth with and/or at familial risk for BD ranging from 13 to 23 years of age. The current study endeavors to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD at CAMH with an emphasis on predictors and mediators of treatment outcomes, with the eventual goal of personalizing treatment selection and delivery. While DBT bodes favorably as a treatment for youth with BD, the literature in this area remains sparse. Moreover, the investigators do not yet understand what clinical characteristics and pre-treatment variables predict and mediate treatment outcomes. There is substantial between-person and within-person variability among youth with and/or at familial risk for BD in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment. The current study proposes to move beyond questions of efficacy toward identifying individual characteristics that are differentially associated with response to DBT. Identification of baseline demographic and clinical characteristics that are associated with response to DBT (i.e., predictors), as well as time-varying characteristics during the course of treatment (i.e., mediators), could guide iterative optimization of DBT through individualized modifications. Patient engagement will be sought through consultation forums after they have completed the study. Overall, this research endeavors to begin to examine the patient factors that predict and mediate an individual's response to DBT, with important questions to consider, such as: For which youth with and/or at familial risk for BD does this intervention have the greatest effect? Does the intervention have similar effects across sub-groups of youth with BD? The investigators anticipate that the identification of predictor and mediating variables has the potential to inform the iterative personalization of DBT for youth with and/or at familial risk for BD in the future, including content, timing, and relative emphasis on various aspects of DBT (e.g., psychoeducation, skills, individual sessions, family involvement, phone coaching).

Eligibility criteria: Inclusion Criteria:

1) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD 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; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6a) At least 1 suicide attempt in the past year (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR non-suicidal self-injurious (NSSI) behaviors in the past 3 months (as measured by the C-SSRS) -OR- 6b) Meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, and impairment); 7) Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

1) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (\< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder.

Primary outcomes:
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 6 months to 12 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline to 3 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 3 months to 6 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 6 months to 9 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 9 months to 12 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: Baseline to 3 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 3 months to 6 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 6 months to 9 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 9 months to 12 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 6 months to 12 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to 6 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months to 12 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline to 3 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 3 months to 6 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 6 months to 9 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 9 months to 12 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 3 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 6 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 9 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 12 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: Baseline to 3 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 3 months to 6 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 6 months to 9 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 9 months to 12 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: Baseline to 3 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 3 months to 6 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 6 months to 9 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 9 months to 12 months
measure: Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF)
timeFrame: Baseline to 6 months
measure: Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF)
timeFrame: 6 months to 12 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: Baseline to 3 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 3 months to 6 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 6 months to 9 months
measure: Change in temperament using the Conflict Behavior Questionnaire (CBQ)
timeFrame: 9 months to 12 months
measure: Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
timeFrame: Baseline to 3 months
measure: Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
timeFrame: 3 months to 6 months
measure: Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
timeFrame: 6 months to 9 months
measure: Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
timeFrame: 9 months to 12 months
measure: Number, frequency, and type of therapy sessions
timeFrame: At the end of study completion (five years)
Secondary outcomes:
measure: Childhood Trust Events Survey (CTES)
timeFrame: Baseline
measure: Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
timeFrame: Baseline to 3 months
measure: Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
timeFrame: 3 months to 6 months
measure: Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
timeFrame: 6 months to 9 months
measure: Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
timeFrame: 9 months to 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: