Stepped Care for Youth at Risk of Psychosis

NCT ID: NCT04829292

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-04-30

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

Detailed Description

In treating youth at clinical high risk of developing psychosis we have not been able to address what treatment to offer first and when to offer more intense and, ultimately, more costly treatments. The goals of achieving Precision Health objectives require that these questions be addressed through research.

The overall aim is to determine the most effective and efficient way to offer active and maintenance treatment resources for CHR youth. The first step would be to offer a range of treatments starting with the most benign as advocated in the McGorry and Hickie stage model. We will use this project to test whether clinical staging will improve prediction of prognosis and result in improved matching of treatment. The specific objectives of this project are: (1) to determine which and what proportion of participants would remit (i) within the first 1-2 months of treatment, (ii) after a brief supportive therapy, (iii) after longer term, focused psychological interventions such as CBT, CBSST and family intervention and (iv) how many make use of medications; (2) to determine adherence of CHR individuals to different treatments; and (3) to determine the need for maintenance treatment. To assess these objectives the following outcomes will be determined:

1. Improvement of Attenuated Psychotic Symptoms

2. Improved social functioning as rated by Global: Social Functioning

3. Percentage of the sample that demonstrate either symptomatic or functional improvement after Step 1 treatments and do not require to move to Step 2 treatments.

4. Percentage of sample that move to Step 2 Treatments and the percentage that achieve improvement in either symptoms or functioning.

5. Percentage of participants allocated to a given treatment that adhere to the treatment.

Participants will be between ages 12 and 30. We will recruit 60 participants who meet well-established criteria for clinical high risk for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS).

Assessments will be conducted at baseline and 2, 6, 12, and 18 months after baseline. Assessments consist of clinical assessments. Clinical raters will be experienced raters and will be trained on all clinical measures and routine reliability checks will be conducted.

Conditions

Clinical High Risk for Developing Psychosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Open treatment

Supportive therapy followed by CBT

Group Type: EXPERIMENTAL

Supportive therapy and CBT

Intervention Type: BEHAVIORAL

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

Interventions

Supportive therapy and CBT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Meeting SIPS criteria for clinical high risk for psychosis

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Jean Addington, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean M Addington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Mathison Centre for Research and Education, University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Monica Chu

Role: CONTACT

mochu@ucalgary.ca

403-210-8737

Cari Jahraus

Role: CONTACT

cari.jahraus@ucalgary.ca

403-210-8740

Other Identifiers

ACH Foundation

Identifier Type: -

Identifier Source: org_study_id