NCT Number: NCT05153382
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.
Interested in participating?
Request Info13 year–23 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M6J 1H4, Canada
Location status: Recruiting
Amanda Moss, MSW
CONTACT
416-535-8501 ext. 33227
Benjamin I Goldstein, MD, PhD
PRINCIPAL_INVESTIGATOR
Vanessa Rajamani, MSW
CONTACT
416-535-8501 ext. 31761
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly meetings and individual therapy conducted in 60 minute biweekly sessions. Family participation in skills training is highly encouraged. Skills training proceeds as follows: 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, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants by cell phone for in-vivo skills coaching between sessions.
Other names: DBT
Time frame: Baseline to 6 months
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.
Time frame: 6 months to 12 months
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.
Time frame: Baseline to 3 months
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time frame: 3 months to 6 months
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time frame: 6 months to 9 months
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time frame: 9 months to 12 months
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time frame: Baseline to 3 months
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time frame: 3 months to 6 months
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time frame: 6 months to 9 months
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time frame: 9 months to 12 months
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time frame: Baseline to 6 months
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Time frame: 6 months to 12 months
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Time frame: Baseline to 6 months
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Time frame: 6 months to 12 months
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Time frame: Baseline to 3 months
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time frame: 3 months to 6 months
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time frame: 6 months to 9 months
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time frame: 9 months to 12 months
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time frame: 3 months
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time frame: 6 months
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time frame: 9 months
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time frame: 12 months
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time frame: Baseline to 3 months
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time frame: 3 months to 6 months
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time frame: 6 months to 9 months
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time frame: 9 months to 12 months
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time frame: Baseline to 3 months
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time frame: 3 months to 6 months
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time frame: 6 months to 9 months
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time frame: 9 months to 12 months
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time frame: Baseline to 6 months
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity. This will be completed for participants aged 19 and younger.
The GAF is a scale originally included in the Diagnostic and Statistical Manual of Mental Disorders (DSM; 4th edition), and is used to rate adult participants' lowest and highest level of functioning in the past year, as well as their current level. It has been found to be reliable and valid. This will be completed for participants aged 20 and older.
Time frame: 6 months to 12 months
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity. This will be completed for participants aged 19 and younger.
The GAF is a scale originally included in the Diagnostic and Statistical Manual of Mental Disorders (DSM; 4th edition), and is used to rate adult participants' lowest and highest level of functioning in the past year, as well as their current level. It has been found to be reliable and valid. This will be completed for participants aged 20 and older.
Time frame: Baseline to 3 months
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time frame: 3 months to 6 months
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time frame: 6 months to 9 months
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time frame: 9 months to 12 months
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time frame: Baseline to 3 months
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time frame: 3 months to 6 months
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time frame: 6 months to 9 months
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time frame: 9 months to 12 months
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time frame: At the end of study completion (five years)
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.
Time frame: Baseline
Youth will complete the Childhood Trust Events Survey (CTES) long-form, adolescent version, a 30-item self-report screening survey that assesses exposure to adversity across a breadth of domains including physical, emotional, and sexual abuse; alcohol/drug users in home; family members in prison; caregiver with mental illness; domestic violence; loss/separation from caregiver; and other traumatic events. In addition, the CTES queries the age and perceived intensity of each type of adversity. Parents will complete the caregiver version of the CTES, a 26-item survey that asks if their child has been exposed to the same domains of adversity as queried in the adolescent version.
Time frame: Baseline to 3 months
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time frame: 3 months to 6 months
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time frame: 6 months to 9 months
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time frame: 9 months to 12 months
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Contact information is provided by the study sponsor or research team.
Amanda Moss, MSW
CONTACT
416-535-8501 ext. 33227
Vanessa Rajamani, MSW
CONTACT
416-535-8501 ext. 31761
Centre for Addiction and Mental Health
Other
Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder: Focus on Predictors and Mediators of Treatment Outcomes
Acronym: DB1
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