Digital Dialectical Behavioural Therapy for High Risk for Psychosis

Overseen By Thea Hedemann, MD, FRCPC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychotic disorder, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital therapy called Dialectical Behavior Therapy (d-DBT) for young people at high risk of developing psychosis. The goal is to determine if this online therapy improves emotional control, reduces psychiatric symptoms, and enhances overall daily functioning. Participants will join one of two groups: one receives the digital therapy, while the other continues with their usual treatment. This trial suits those aged 16-29 who have been identified as at risk for psychosis within the last three years and are not currently receiving other structured mental health support. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future mental health treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot receive any additional psychotherapy or structured digital mental health support during the study.

What prior data suggests that this digital dialectical behavioral therapy is safe for youth at high risk for psychosis?

Research has shown that digital Dialectical Behavior Therapy (d-DBT) is generally safe and well-tolerated. Studies on digital DBT have found that participants accept it well, with few reports of negative effects. In one study, patients using digital DBT did not report significant side effects. Instead, they experienced better control over their emotions and a decrease in mental health symptoms.

Traditional DBT, used in many settings, is known for its safety and effectiveness. This suggests that the digital version should also be safe, as it is based on proven methods. Overall, while more research is needed to confirm these findings for digital formats, current evidence is promising for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Digital Dialectical Behavioural Therapy (d-DBT) for high risk for psychosis because it offers a unique digital approach to therapy. Unlike traditional in-person therapy sessions, d-DBT uses digital tools to make therapeutic techniques more accessible and flexible for patients. This digital format can help individuals engage with therapy at their own pace and in their own environment, potentially increasing adherence and effectiveness. Additionally, d-DBT integrates specific skills training aimed at emotional regulation and distress tolerance, which are crucial for individuals at high risk for psychosis.

What evidence suggests that digital dialectical behavioral therapy is effective for high risk for psychosis?

Research has shown that digital Dialectical Behavior Therapy (d-DBT), which participants in this trial may receive, could benefit young people at high risk for psychosis. One study found that d-DBT greatly lowered scores on a test measuring suicidal thoughts and behaviors. This suggests that d-DBT might help individuals manage emotions better and reduce mental health symptoms. Traditional DBT has proven effective in other contexts, supporting the potential of its digital version. Overall, early results are promising for using d-DBT with this high-risk group. ^{1 2 4 5 6}

Who Is on the Research Team?

M. Omair Husain, MBBS, MRCPsych

Principal Investigator

The Centre for Addiction and Mental Health (CAMH)

Are You a Good Fit for This Trial?

This trial is for young people who are at high risk of developing psychosis, which includes conditions like schizophrenia. Participants should be willing to use a digital therapy program over eight weeks and have not yet developed full-blown psychosis.

Inclusion Criteria

Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.

I am mentally capable and agree to join the study.

I am between 16 and 29 years old.

Exclusion Criteria

I am not participating in any other psychotherapy or digital mental health programs.

Severe developmental disorder

Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the digital Dialectical Behavior Therapy (d-DBT) intervention or treatment as usual over eight weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Dialectical Behavioural Therapy (d-DBT)

Trial Overview The study tests a digital version of dialectical behavior therapy (d-DBT) against standard treatments. It's designed to see if d-DBT can help manage emotions, reduce symptoms related to mental health disorders, and improve overall functioning in youth at risk for psychosis.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

This arm will receive the d-DBT intervention.

Group II: Control (Treatment as Usual) Active Control 1 Intervention

This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

A comprehensive Dialectical Behavior Therapy (DBT) program was developed for patients with recent psychiatric hospitalization and significant emotion dysregulation, including a notable 58% of participants having a history of psychosis.

Preliminary evaluation showed that patients improved on most measures of suicidality, emotion regulation, and depression, with no hospitalizations or suicide attempts during treatment, indicating the program's potential efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. Phalen, P., Grossmann, J., Bruder, T., et al.[2022]

Participants with psychosis engaged well with the Actissist app, responding to 47% of notifications, with the majority of interactions being initiated by the app itself, particularly in areas related to voice-hearing and paranoia.

The study suggests that financial incentives may enhance app engagement, indicating a need for future research to explore non-incentivized engagement in larger groups to better understand the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis. Eisner, E., Berry, N., Morris, R., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-psychotic-disorders-3-2025-f4acb

Digital Dialectical Behavioural Therapy for High Risk ... This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12092405/

A Digital Dialectical Behaviour Therapy Intervention for ... The d-DBT intervention demonstrated significant reductions in C-SSRS scores (Cohen's −1.0) compared to standard of care. No significant group ...

3. ctv.veeva.com ctv.veeva.com/study/digital-dialectical-behavioural-therapy-d-dbt-for-youth-at-clinical-high-risk-chr-for-psychosis

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at ... This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at ...

4. jaapl.org jaapl.org/content/early/2024/04/30/JAAPL.240009-24

Effectiveness of Dialectical Behavior Therapy (DBT) in a ... Taken together, the research findings suggest that DBT is an effective treatment for improving outcomes and safety in an inpatient forensic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06928935

Digital Dialectical Behavioural Therapy (d-DBT) for Youth ... This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk ( ...

6. formative.jmir.org formative.jmir.org/2025/1/e66181

Acceptance, Safety, and Effect Sizes in Online Dialectical ... Objective: This study aims to provide initial effect size estimates of symptom change from pre- to post treatment, and the acceptance and safety ...