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Trial record 77 of 168 for:    personality AND therapy AND severity | Recruiting, Not yet recruiting, Available Studies

Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03661333
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

Brief Summary:
The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Dialectical behavioral therapy Not Applicable

Detailed Description:

This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.

Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.

Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Adolescents with bipolar disorder
40 adolescents aged 13 to 19 with bipolar disorder (type I, type II, not otherwise specified/nos) will be enrolled in the dialectical behavioral therapy intervention.
Behavioral: Dialectical behavioral therapy
DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent 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 and their participating family members by cell phone for in-vivo skills coaching between sessions.
Other Name: DBT




Primary Outcome Measures :
  1. Therapist satisfaction and acceptability [ Time Frame: 6 months ]
    Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 6 months. Acceptability will be defined as mean acceptability ratings > 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  2. therapists will adhere to the DBT Adherence Rating Scale [ Time Frame: End of study year 2 ]
    Tapes will be rated for adherence using the DBT Adherence Rating scale. The scale generates a Global Score of DBT adherence and subscale scores for the 12 DBT strategy domains. To examine sustained adherence, each therapist will submit 3 consecutive sessions for adherence coding. The rating scale is not available to the public and is utilized by the DBT-Linehan Board of Certification (copyright). Please see http://www.dbt-lbc.org/downloads/Applicant_Handbook_final_with_RW_review_2018.pdf for more information.

  3. Therapists will obtain a passing grade of the DBT Certification Exam [ Time Frame: 1 year ]
    Clinicians will attain knowledge and fidelity required to pass the DBT certification examination (exam total score ≥ 80%; passing score on case conceptualization; two of three consecutive tapes coded at or above adherence). Please see the certification manual http://www.dbt-lbc.org/downloads/Applicant_Handbook_final_with_RW_review_2018.pdf for more information.

  4. Therapist satisfaction and acceptability [ Time Frame: 12 months ]
    Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 12 months. Acceptability will be defined as mean acceptability ratings > 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  5. Therapist satisfaction and acceptability [ Time Frame: 24 months ]
    Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 24 months. Acceptability will be defined as mean acceptability ratings > 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").


Secondary Outcome Measures :
  1. Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE) [ Time Frame: Baseline to 6 months ]
    The LIFE will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study

  2. Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE) [ Time Frame: 6 months to 12 months ]
    The LIFE will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study

  3. Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL) [ Time Frame: Baseline ]
    The K-SADS-PL is a semi-structured interview designed to ascertain present episode and lifetime history of psychiatric illness, according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for children and adolescents.

  4. K-SADS Mania Rating Scale (MRS) [ Time Frame: Baseline ]
    The K-SADS MRS is a 13-item rating scale with scores ranging from 0 to 6. In addition to assessing common manic symptoms, it includes the K-SADS-PL items that assess the presence and severity of hallucinations and delusions.

  5. Depression section of the K-SADS-Present Episode Version (K-SADS-Dep) [ Time Frame: Baseline ]
    The K-SADS-Dep will be used to assess the presence and severity of depressive symptoms. It is a 21-item semi-structured interview that allows depression symptom severity to be rated on a 6-point scale, from none to severe.

  6. Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS) [ Time Frame: Baseline to 3 months ]
    Parent and adolescent reported depressive and manic symptoms will be measured via the CMRS. The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale.

  7. Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS) [ Time Frame: 3 months to 6 months ]
    Parent and adolescent reported depressive and manic symptoms will be measured via the CMRS. The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale.

  8. Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS) [ Time Frame: 6 months to 9 months ]
    Parent and adolescent reported depressive and manic symptoms will be measured via the CMRS. The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale.

  9. Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS) [ Time Frame: 9 months to 12 months ]
    Parent and adolescent reported depressive and manic symptoms will be measured via the CMRS. The CMRS is a valid 21-item screening instrument, reflecting the DSM-IV criteria for a manic episode, with each response rated on a four-point Likert-type scale.

  10. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to 6 months ]
    We will assess suicidal events (past and over follow-up) with the Pediatric Version of the 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.

  11. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months to 12 months ]
    We will assess suicidal events (past and over follow-up) with the Pediatric Version of the 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.

  12. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: Baseline to 3 months, ]
    Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  13. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 3 months to 6 months ]
    Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  14. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 6 months to 9 months ]
    Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  15. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 9 months to 12 months ]
    Self-reported depressive and manic symptoms will be measured via the MFQ. Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").

  16. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: Baseline to 3 months ]
    Adolescents will also complete the self-report SIQ, which is intended to identify adolescents 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 adolescent experiences each thought.

  17. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 3 months to 6 months ]
    Adolescents will also complete the self-report SIQ, which is intended to identify adolescents 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 adolescent experiences each thought.

  18. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 6 months to 9 months ]
    Adolescents will also complete the self-report SIQ, which is intended to identify adolescents 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 adolescent experiences each thought.

  19. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 9 months to 12 months ]
    Adolescents will also complete the self-report SIQ, which is intended to identify adolescents 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 adolescent experiences each thought.

  20. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline to 3 months ]
    Adolescents will also complete the 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%" to 5= "almost always; 91-100%".

  21. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 3 months to 6 months ]
    Adolescents will also complete the 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%" to 5= "almost always; 91-100%".

  22. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 6 months to 9 months ]
    Adolescents will also complete the 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%" to 5= "almost always; 91-100%".

  23. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 9 months to 12 months ]
    Adolescents will also complete the 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%" to 5= "almost always; 91-100%".

  24. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 12 months ]
    Following the year-long DBT intervention, patients and parents 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.

  25. Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder [ 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.

  26. Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder [ 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.

  27. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: Baseline to 3 months ]
    The 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.

  28. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 3 months to 6 months ]
    The 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.

  29. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 6 months to 9 months ]
    The 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.

  30. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 9 months to 12 months ]
    The 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.

  31. DBT Barriers to Implementation [ Time Frame: 6 months, 12 months, 24 months ]
    The DBT barriers to Implementation (DBT-BTI) is a 26-item self-report survey that assesses barriers to DBT implementation in four domains: team, direction/motivation, theoretical position/philosophy, and administrative/structural problems. To be completed by DBT therapist participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • Age 13 years, 0 months to 19 years, 11 months
  • Meet diagnostic criteria for BD by KSADS-PL
  • Engaged in, or willing to proceed with, a pharmacotherapy regimen
  • At least one parent/guardian with whom the patient lives or regularly interacts (>5 hours per week) is willing to participate in skills training
  • Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

  • Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
  • A life-threatening medical condition requiring immediate treatment
  • Current victim of sexual or physical abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661333


Contacts
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Contact: Jessica L Roane, MSW 416-480-6067 jessica1.roane@sunnybrook.ca
Contact: Vanessa H Timmins, MSW 416-480-6063 vanessa.timmins@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Jessica L Roane, MSW    416-480-6067    jessica1.roane@sunnybrook.ca   
Contact: Vanessa H Timmins, MSW    416-480-6063    vanessa.timmins@sunnybrook.ca   
Principal Investigator: Benjamin I Goldstein, MD, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Pittsburgh
Investigators
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Principal Investigator: Benjamin I Goldstein, MD, PhD Sunnybrook Research Insitute

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Responsible Party: Dr. Benjamin Goldstein, Senior Scientist, Psychiatrist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03661333     History of Changes
Other Study ID Numbers: 042-2018
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre:
dialectical behavior therapy
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders