Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
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 volunteersQualifiers
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.
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
Behaviorald-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 groupsGroup 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 weeks2
Retention
The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.
Time frame
8 weeks3
Adherence
Percentage of modules completed; higher percentages indicate greater adherence.
Time frame
8 weeks4
Client Satisfaction Questionnaire
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Time frame
8 weeksSecondary 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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov