Clinical High Risk for Psychosis (CHR)NCT06928935
Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis
A study testing d-DBT in people with Clinical High Risk for Psychosis (CHR), run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy… Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- d-DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2026to 1 Jan 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be 14-35 years old.
- Being competent and willing to consent to study participation.
- Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.
Who cannot join
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
- Diagnosis of intellectual disability
- Severe developmental disorder
- Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.
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, M6J1H4
Omair Husain, MBBS, 416-535-8501, omair.husain@camh.ca
Thea Hedemann, MD, FRCPC, 416-535-8501, thea.hedemann@camh.ca
About this study
Official title: Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study
This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.
Read the detailed description
This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease.
Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- d-DBT
- Keywords
- digital therapy, dialectical behavioural therapy, emotional dysregulation, mental health intervention, digital mental health, clinical high risk for psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-DBTBehavioural
d-DBT is an 8-week self-led online intervention that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills. Participants receive weekly digital navigator check-ins.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This arm will receive the d-DBT intervention. Receives: Behavioral: d-DBT |
| Control (Treatment as Usual) | No intervention | This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.
Measured: 8 weeks
Retention
The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.
Measured: 8 weeks
Adherence
Percentage of modules completed; higher percentages indicate greater adherence.
Measured: 8 weeks
Client Satisfaction Questionnaire
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Measured: 8 weeks
System Usability Scale
A 10-item Likert scale scored from 1-5; total scores range from 0-100, with higher scores indicating greater perceived usability.
Measured: 8 weeks
Secondary outcomes (14)
Structured Interview for Psychosis-risk Syndromes (SIPS)
The Structured Interview for Prodromal Symptoms (SIPS) is a widely used structured interview for diagnosing a CHR syndrome for psychosis and cases of first episode psychosis. It contains a severity rating scale (the Scale Of Psychosis-risk Symptoms, or SOPS). It is a 6-point scale, with higher scores indicating higher severity.
Measured: Baseline and 8 weeks
PRIME-Revised (PRIME-R)
A 12-item Likert scale (0-6) measuring severity of prodromal psychotic symptoms; total scores range from 0-72, with higher scores indicating greater symptom severity.
Measured: Baseline and 8 weeks
Borderline Symptom List (BSL-23)
A 23-item Likert scale scored from 0-4; total scores range from 0-92, with higher scores indicating greater severity of borderline personality symptoms.
Measured: Baseline and 8 weeks
Brief Difficulties in Emotion Regulation Scale (DERS-16)
A 16-item Likert scale scored from 1-5; total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation.
Measured: Baseline and 8 weeks
State-Trait Anxiety Inventory (STAI)
A 40-item measure (20 items for state anxiety, 20 items for trait anxiety) scored on a 4-point Likert scale (1-4); total scores range from 20-80 per subscale, with higher scores indicating greater anxiety.
Measured: Baseline and 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
A 9-item clinician-rated scale scored from 0-3 per item; total scores range from 0-27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline and 8 weeks
Global Functioning: Social and Role Scales
Two clinician-rated scales ranging from 1-10 each, assessing social and role functioning; higher scores indicate better overall functioning.
Measured: Baseline and 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
A 25-item Likert scale scored from 0-4; total scores range from 0-100, with higher scores indicating greater resilience.
Measured: Baseline and 8 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
A structured clinical interview assessing suicidal ideation and behavior severity; scores include ideation severity (0-5) and behavior presence; higher scores indicate greater suicide risk.
Measured: Baseline and 8 weeks
MATRICS Consensus Cognitive Battery (MCCB)
A standardized cognitive assessment comprising 10 tests across 7 domains; total composite T-scores typically range from 10-90, with higher scores indicating better cognitive functioning.
Measured: Baseline and 8 weeks
Timeline Follow Back (TLFB)
A calendar-based assessment method recording daily cannabis, alcohol, and tobacco use over the past 7 days; higher frequency or quantity indicates greater substance use.
Measured: Baseline and 8 weeks
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
An 8-item screening tool scored from 0-32; higher scores indicate increased risk or severity of cannabis use disorder.
Measured: Baseline and 8 weeks
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
A self-report questionnaire assessing detailed patterns of cannabis use, including daily sessions, frequency, age of first use, and quantity consumed; higher values indicate greater cannabis involvement.
Measured: Baseline and 8 weeks
Adolescent Alcohol and Drug Involvement Scale (AADIS)
A brief screening tool scoring substance use involvement from 0-79; higher scores indicate greater severity of alcohol and drug involvement.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start28 Apr 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omair Husain, Centre for Addiction and Mental Health
- Investigators
- M. Omair Husain, MBBS, MRCPsych, Principal investigator, The Centre for Addiction and Mental Health (CAMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928935
- Sponsor's protocol ID
- 2025/007
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available on reasonable request from the principal investigator.
Publications
Lawlor C, Vitoratou S, Hepworth C, Jolley S. Self-reported emotion regulation difficulties in psychosis: Psychometric properties of the Difficulties in Emotion Regulation Scale (DERS-16). J Clin Psychol. 2021 Oct;77(10):2323-2340. doi: 10.1002/jclp.23164. Epub 2021 May 10.
PubMed 33971018Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.
PubMed 20347232Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31.
PubMed 23276315Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
PubMed 12964174Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
PubMed 14989408Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27.
PubMed 24974307Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.
PubMed 25806661Woods SW, Addington J, Cadenhead KS, Cannon TD, Cornblatt BA, Heinssen R, Perkins DO, Seidman LJ, Tsuang MT, Walker EF, McGlashan TH. Validity of the prodromal risk syndrome for first psychosis: findings from the North American Prodrome Longitudinal Study. Schizophr Bull. 2009 Sep;35(5):894-908. doi: 10.1093/schbul/sbp027. Epub 2009 Apr 21.
PubMed 19386578Addington J, van der Gaag M. Psychosocial treatments for clinical high risk individuals. Schizophr Bull. 2015 Jan;41(1):22. doi: 10.1093/schbul/sbu140. Epub 2014 Oct 14. No abstract available.
PubMed 25316912Fusar-Poli P, De Micheli A, Signorini L, Baldwin H, Salazar de Pablo G, McGuire P. Real-world long-term outcomes in individuals at clinical risk for psychosis: The case for extending duration of care. EClinicalMedicine. 2020 Oct 7;28:100578. doi: 10.1016/j.eclinm.2020.100578. eCollection 2020 Nov.
PubMed 33294806Hedemann TL, Lu Y, Campitelli S, Hawke LD, Shen N, Saperia S, Jones BDM, Strudwick G, Wilks CR, Wang W, Solmi M, Grossman M, Husain MI, Kozloff N, Foussias G, Husain MO. Adaptation and evaluation of a digital dialectical behaviour therapy for youth at clinical high risk for psychosis: A protocol for a feasibility randomized controlled trial. PLoS One. 2025 Dec 23;20(12):e0339163. doi: 10.1371/journal.pone.0339163. eCollection 2025.
PubMed 41433354
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study
- ClinicalTrials.gov ID
- NCT06928935
- Acronym / sponsor ID
- 2025/007
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Keywords
- digital therapy, dialectical behavioural therapy, emotional dysregulation, mental health intervention, digital mental health, clinical high risk for psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 Apr 2025 (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.
This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.
Detailed description
This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease.
Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: d-DBTThis arm will receive the d-DBT intervention. |
| Control (Treatment as Usual) | No intervention | –This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Be 14-35 years old.
- Being competent and willing to consent to study participation.
- Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.
Key exclusion criteria (5 listed)
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
- Diagnosis of intellectual disability
- Severe developmental disorder
- Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.
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 |
|---|---|---|
| d-DBTd-DBT is an 8-week self-led online intervention that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills. Participants receive weekly digital navigator check-ins. | Behavioural | Experimental |
Primary outcome
Recruitment
Time frame: 8 weeks
The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.
Retention
Time frame: 8 weeks
The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.
Adherence
Time frame: 8 weeks
Percentage of modules completed; higher percentages indicate greater adherence.
Client Satisfaction Questionnaire
Time frame: 8 weeks
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
System Usability Scale
Time frame: 8 weeks
A 10-item Likert scale scored from 1-5; total scores range from 0-100, with higher scores indicating greater perceived usability.
14 secondary outcomes
Structured Interview for Psychosis-risk Syndromes (SIPS)
Time frame: Baseline and 8 weeks
PRIME-Revised (PRIME-R)
Time frame: Baseline and 8 weeks
Borderline Symptom List (BSL-23)
Time frame: Baseline and 8 weeks
Brief Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: Baseline and 8 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline and 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Baseline and 8 weeks
Global Functioning: Social and Role Scales
Time frame: Baseline and 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline and 8 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline and 8 weeks
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Baseline and 8 weeks
Timeline Follow Back (TLFB)
Time frame: Baseline and 8 weeks
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
Time frame: Baseline and 8 weeks
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
Time frame: Baseline and 8 weeks
Adolescent Alcohol and Drug Involvement Scale (AADIS)
Time frame: Baseline and 8 weeks
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 9 Sep 2026.
- Background: PubMed 33971018Lawlor C, Vitoratou S, Hepworth C, Jolley S. Self-reported emotion regulation difficulties in psychosis: Psychometric properties of the Difficulties in Emotion Regulation Scale (DERS-16). J Clin Psychol. 2021 Oct;77(10):2323-2340. doi: 10.1002/jclp.23164. Epub 2021 May 10.
- Background: PubMed 20347232Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.
- Background: PubMed 23276315Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31.
- Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Background: PubMed 12964174Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Background: PubMed 14989408Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Background: PubMed 24974307Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27.
- Background: PubMed 25806661Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.
- Background: PubMed 19386578Woods SW, Addington J, Cadenhead KS, Cannon TD, Cornblatt BA, Heinssen R, Perkins DO, Seidman LJ, Tsuang MT, Walker EF, McGlashan TH. Validity of the prodromal risk syndrome for first psychosis: findings from the North American Prodrome Longitudinal Study. Schizophr Bull. 2009 Sep;35(5):894-908. doi: 10.1093/schbul/sbp027. Epub 2009 Apr 21.
- Background: PubMed 25316912Addington J, van der Gaag M. Psychosocial treatments for clinical high risk individuals. Schizophr Bull. 2015 Jan;41(1):22. doi: 10.1093/schbul/sbu140. Epub 2014 Oct 14. No abstract available.
- Background: PubMed 33294806Fusar-Poli P, De Micheli A, Signorini L, Baldwin H, Salazar de Pablo G, McGuire P. Real-world long-term outcomes in individuals at clinical risk for psychosis: The case for extending duration of care. EClinicalMedicine. 2020 Oct 7;28:100578. doi: 10.1016/j.eclinm.2020.100578. eCollection 2020 Nov.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available on reasonable request from the principal investigator.
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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.
M. Omair Husain, MBBS, MRCPsych principal investigator
The Centre for Addiction and Mental Health (CAMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing d-DBT in people with Clinical High Risk for Psychosis (CHR), 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 3 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 9 Sep 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 M. Omair Husain, MBBS, MRCPsych (416-535-8501 ext. 36467, omair.husain@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928935, which also lists 13 linked publications.
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 9 Sep 2026.