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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-29
SponsorCentre for Addiction and Mental Health

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: Control (Treatment as Usual)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment

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

Time frame
8 weeks
2

Retention

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

Time frame
8 weeks
3

Adherence

Percentage of modules completed; higher percentages indicate greater adherence.

Time frame
8 weeks
4

Client Satisfaction Questionnaire

A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and 8 weeks
4

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.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

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