NCT04829292

Brief Summary

The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Sep 2021Jun 2026

First Submitted

Initial submission to the registry

March 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

March 29, 2021

Last Update Submit

April 27, 2026

Conditions

Clinical High Risk for Developing Psychosis

Outcome Measures

Primary Outcomes (1)

  • Scale of Psychosis Risk Symptoms

    Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.

    Baseline and 18 months

Secondary Outcomes (1)

  • Global Functioning Scale: Social and Role

    Baseline and 18 months

Study Arms (1)

Open treatment

EXPERIMENTAL

Supportive therapy followed by CBT

Behavioral: Supportive therapy and CBT

Interventions

Supportive therapy and CBTBEHAVIORAL

In this open trial participants are first offered supportive therapy followed by CBT

Open treatment

Eligibility Criteria

Age12 Years - 30 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meeting SIPS criteria for clinical high risk for psychosis

You may not qualify if:

  • meeting criteria for any current or past axis I psychotic disorder, IQ less than 70, or past or current history of a clinically significant central nervous system disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathison Centre for Research and Education, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jean M Addington, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 2, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)