Bipolar DisorderDB2NCT05627492
Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
A study testing Dialectical behavioral therapy in people with Bipolar Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Dialectical behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2022to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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;
- Followed by a psychiatrist who provides ongoing care;
- If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
- Able and willing to give informed consent/assent to participate.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Vanessa Rajamani, MSW, 416-535-8501 ext. 31761, vanessa.rajamani@camh.ca
Amanda Moss, MSW, 416-535-8501 ext. 33227, amanda.moss@camh.ca
About this study
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.
Read the detailed 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.
- Conditions
- Bipolar Disorder
- Being tested
- Dialectical behavioral therapy
- Keywords
- Youth, Dialectical Behavior Therapy (DBT), Suicide, Psychotherapy
- Medical subject headings
- Bipolar Disorder, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioral therapyBehavioural
Also called DBT
DBT 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.
| Study group | Role | What they receive |
|---|---|---|
| Youth with and/or at familial risk for bipolar disorder | Experimental | 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. Receives: Behavioral: Dialectical behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of study completion (five years)
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.
Measured: At the end of study completion (five years)
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.
Measured: At the end of study completion (five years)
Secondary outcomes (28)
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.
Measured: At the end of study completion (five years)
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.
Measured: At the end of study completion (five years)
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.
Measured: 12 months to 18 months
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.
Measured: 18 months to 24 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
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.
Measured: 12 months to 15 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
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.
Measured: 15 months to 18 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
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.
Measured: 18 months to 21 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
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.
Measured: 21 months to 24 months
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
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.
Measured: 12 months to 18 months
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
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.
Measured: 18 months to 24 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Measured: 12 months to 18 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Measured: 18 months to 24 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
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".
Measured: 12 months to 15 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
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".
Measured: 15 months to 18 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
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".
Measured: 18 months to 21 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
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".
Measured: 21 months to 24 months
Treatment Satisfaction Questionnaire (18-item)
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.
Measured: 15 months
Treatment Satisfaction Questionnaire (18-item)
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.
Measured: 18 months
Treatment Satisfaction Questionnaire (18-item)
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.
Measured: 21 months
Treatment Satisfaction Questionnaire (18-item)
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.
Measured: 24 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
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".
Measured: 12 months to 15 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
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".
Measured: 15 months to 18 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
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".
Measured: 18 months to 21 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
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".
Measured: 21 months to 24 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
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.
Measured: 12 months to 15 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
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.
Measured: 15 months to 18 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
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.
Measured: 18 months to 21 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
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.
Measured: 21 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start9 Nov 2022
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Goldstein, Centre for Addiction and Mental Health
- Investigators
- Benjamin I Goldstein, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627492
- Sponsor's protocol ID
- 099/2022
- Acronym
- DB2
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05627492
- Acronym / sponsor ID
- DB2 / 099/2022
- Conditions
- Bipolar Disorder
- Keywords
- Youth, Dialectical Behavior Therapy (DBT), Suicide, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth with and/or at familial risk for bipolar disorder | Experimental | Behavioral: Dialectical behavioral therapy120 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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;
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavioral therapyAlso: DBTDBT 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. | Behavioural | Youth with and/or at familial risk for bipolar disorder |
Primary outcome
Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form
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.
Number of unscheduled/expedited DBT sessions that are required measured using the Therapy
Time frame: At the end of study completion (five years)
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
Time frame: At the end of study completion (five years)
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.
28 secondary outcomes
Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
Time frame: At the end of study completion (five years)
Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form
Time frame: At the end of study completion (five years)
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Time frame: 12 months to 18 months
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Time frame: 18 months to 24 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 12 months to 15 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 15 months to 18 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 18 months to 21 months
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Time frame: 21 months to 24 months
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
Time frame: 12 months to 18 months
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
Time frame: 18 months to 24 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 12 months to 18 months
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 18 months to 24 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 12 months to 15 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 15 months to 18 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 18 months to 21 months
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 21 months to 24 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 15 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 18 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 21 months
Treatment Satisfaction Questionnaire (18-item)
Time frame: 24 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Time frame: 12 months to 15 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Time frame: 15 months to 18 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Time frame: 18 months to 21 months
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Time frame: 21 months to 24 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Time frame: 12 months to 15 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Time frame: 15 months to 18 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Time frame: 18 months to 21 months
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Time frame: 21 months to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Related trials for Bipolar Disorder
Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Not yet recruitingObservational study
Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders
Major Depressive Disorder, Bipolar Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin I Goldstein, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioral therapy in people with Bipolar Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Rajamani, MSW (416-535-8501 ext. 31761, vanessa.rajamani@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form (time frame: At the end of study completion (five years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.