NCT07569471

Brief Summary

The current study is an open-label, proof-of-concept, pilot trial examining the feasibility, safety, and preliminary efficacy of a 6-week group therapy intervention targeting core beliefs related to symptoms of psychosis. Core beliefs are theorized to be central to the development and maintenance of psychosis and other mental health conditions; however, research on how to address this key mechanism in psychosis is rarely directly studied. The primary questions it aims to answer include:

  1. 1.Is targeting core beliefs in a technology-supported remote group therapy format safe and feasible?
  2. 2.Does targeting core beliefs result in measurable change in core beliefs?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Jan 2028

Study Start

First participant enrolled

March 31, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

PsychosisCognitive Behavioural TherapyGroup TherapyRemote TherapyOnline TherapySchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Brief Core Schema Scale

    The BCSS is a validated and widely used self-report measure that quantifies the endorsement of positive and negative self- and other- core beliefs. There are four subscales (positive self, negative self, positive other, negative other). Higher scores on these scales indicate more endorsement of these types of core beliefs: Higher scores on the negative scales indicate a stronger endorsement of dysfunctional schemas, whereas higher scores on the positive scales indicate a stronger endorsement of adaptive, positive views. Subscale scores range from 0-24, and total scores range from 0-96.

    The BCSS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

Secondary Outcomes (8)

  • Scale for the Assessment of Positive Symptoms

    The SAPS is administered at screening (Day 1), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

  • Psychotic Symptom Rating Scales

    The PSYRATS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

  • Scale for the Assessment of Negative Symptoms

    The SANS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

  • Referential Thinking Scale

    The REF Scale is administered at Baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

  • Experiences Questionnaire - Decentering

    The EQ is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).

  • +3 more secondary outcomes

Other Outcomes (2)

  • Usefulness, Satisfaction, and Ease of Use Questionnaire

    The USE Questionnaire is administered once at the end of the study (at 3-month follow-up visit; Weeks 19-21).

  • Satisfaction With Therapy and Therapist Scale-Revised

    STTS-R is administered once post-intervention (Weeks 7-9).

Study Arms (1)

Active Group Therapy

EXPERIMENTAL

As there is only one arm in this open-label, proof-of-concept study, all participants enrolled in this study will have the opportunity to complete a six-week group intervention consisting of integrated skills and strategies within a CBTp framework.

Other: REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time

Interventions

REFLECT is a six-week group therapy intervention delivered remotely on a video conferencing platform that is compliant with health information privacy laws in Ontario. This intervention is additionally supported by remote homework delivery, completion, and review through a secure online database that allows homework to be delivered and completed through email or a smartphone app. Weekly group sessions are 2 hours each and explore negative core beliefs related to symptoms of psychosis through a CBT framework to support the development of more balanced beliefs to support functional and personal recovery.

Active Group Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above the age of 18.
  • Diagnosis of SSD (i.e., Schizophrenia, Schizophreniform, Schizoaffective Disorder, or Delusional Disorder), confirmed based on self-report.
  • Have current symptoms related to psychosis (as determined by a score of 2 or higher on the SAPS).
  • Engaged in current outpatient treatment for psychosis (e.g., medication management by psychiatrist or general practitioner, case management, community mental health treatment, etc.).
  • Has or has access to personal technology (e.g., smartphone, tablet, or laptop/computer) with access to wifi or cellular data.

You may not qualify if:

  • Not capable of providing informed consent (see Consent Procedures).
  • Does not have an SSD diagnosis.
  • Does not experience current delusions.
  • Not currently involved in outpatient treatment.
  • Is currently receiving CBTp.
  • Does not own or have access to personal technology (e.g., smartphone, tablet, or laptop/computer) with access to wifi or cellular data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto Scarborough

Scarborough Village, Ontario, M1C 1A4, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersPsychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Micheal W Best, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR
  • Sean A Kidd, PhD

    University of Toronto

    STUDY DIRECTOR

Central Study Contacts

Jessica D'Arcey, PhD Candidate

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 6, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request.

Locations