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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Digital Dialectical Behavioural Therapy (d-DBT) for high risk for psychosis?

Research shows that digital technologies, like smartphone apps and web-based interventions, can improve access to psychological treatments and have shown positive results in early psychosis. These digital interventions are generally well-received and can enhance therapy outcomes, suggesting that digital approaches like d-DBT may be effective for those at high risk for psychosis. ^{1 2 3 4 5}

How is Digital Dialectical Behavioural Therapy (d-DBT) different from other treatments for high risk for psychosis?

Digital Dialectical Behavioural Therapy (d-DBT) is unique because it combines traditional DBT techniques with digital tools, making it more accessible and potentially more engaging for patients. This approach can help individuals practice and reinforce skills in real-time, which may be particularly beneficial for those at high risk for psychosis who need immediate support and skill application. ^{6 7 8 9 10}

Research Team

M. Omair Husain, MBBS, MRCPsych

Principal Investigator

The Centre for Addiction and Mental Health (CAMH)

Eligibility Criteria

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

Severe developmental disorder

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessing the delivering of iMAgery-focused therapy for PSychosis (iMAPS) via telehealth. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

"I wanted to do more of the homework!"-Feasibility and acceptability of blending app-based homework with group therapy for social cognition in psychosis. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Are we there yet?!-a literature review of recent digital technology advances for the treatment of early psychosis. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Creating Live Interactions to Mitigate Barriers (CLIMB): A Mobile Intervention to Improve Social Functioning in People With Chronic Psychotic Disorders. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Australasian dialectical behaviour therapy pilot outcome study: effectiveness, utility and feasibility. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review of dialectical behavior therapy mobile apps for content and usability. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A pilot study of the DBT coach: an interactive mobile phone application for individuals with borderline personality disorder and substance use disorder. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Towards online delivery of Dialectical Behaviour Therapy: A scoping review. [2022]