Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06928935

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Clinical High Risk for Psychosis (CHR)

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be 16-29 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.

Exclusion criteria

  • 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.

Treatment and study plan

d-DBT

Behavioral

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.

Primary outcomes

  1. Recruitment

    Time frame: 8 weeks

    The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.

  2. Retention

    Time frame: 8 weeks

    The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.

  3. Adherence

    Time frame: 8 weeks

    Percentage of modules completed; higher percentages indicate greater adherence.

  4. 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.

  5. 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.

Secondary outcomes

  1. Structured Interview for Psychosis-risk Syndromes (SIPS)

    Time frame: Baseline and 8 weeks

    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.

  2. PRIME-Revised (PRIME-R)

    Time frame: Baseline and 8 weeks

    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.

  3. Borderline Symptom List (BSL-23)

    Time frame: Baseline and 8 weeks

    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.

  4. Brief Difficulties in Emotion Regulation Scale (DERS-16)

    Time frame: Baseline and 8 weeks

    A 16-item Likert scale scored from 1-5; total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation.

  5. State-Trait Anxiety Inventory (STAI)

    Time frame: Baseline and 8 weeks

    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.

  6. Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame: Baseline and 8 weeks

    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.

  7. Global Functioning: Social and Role Scales

    Time frame: Baseline and 8 weeks

    Two clinician-rated scales ranging from 1-10 each, assessing social and role functioning; higher scores indicate better overall functioning.

  8. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: Baseline and 8 weeks

    A 25-item Likert scale scored from 0-4; total scores range from 0-100, with higher scores indicating greater resilience.

  9. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline and 8 weeks

    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.

  10. MATRICS Consensus Cognitive Battery (MCCB)

    Time frame: Baseline and 8 weeks

    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.

  11. Timeline Follow Back (TLFB)

    Time frame: Baseline and 8 weeks

    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.

  12. Cannabis Use Disorders Identification Test-Revised (CUDIT-R)

    Time frame: Baseline and 8 weeks

    An 8-item screening tool scored from 0-32; higher scores indicate increased risk or severity of cannabis use disorder.

  13. Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)

    Time frame: Baseline and 8 weeks

    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.

  14. Adolescent Alcohol and Drug Involvement Scale (AADIS)

    Time frame: Baseline and 8 weeks

    A brief screening tool scoring substance use involvement from 0-79; higher scores indicate greater severity of alcohol and drug involvement.

Study contacts

Contact information is provided by the study sponsor or research team.

M. Omair Husain, MBBS, MRCPsych

CONTACT

[email protected]

416-535-8501 ext. 36467

Thea Hedemann, MD, FRCPC

CONTACT

[email protected]

416-535-8501 ext. 39357

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.