NCT07569471 REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis
| NCT ID | NCT07569471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Toronto |
| Condition | Schizophrenia Spectrum & Other Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2026-03-31 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Is targeting core beliefs in a technology-supported remote group therapy format safe and feasible? 2. Does targeting core beliefs result in measurable change in core beliefs? The investigators hypothesize that this intervention will be safe and feasible, and that we will see improvements in maladaptive core beliefs. Secondary outcomes include changes in positive and negative symptoms, personal recovery, and whether there are improvements in other cognitive mechanisms, like cognitive biases, and behavioural mechanisms, like safety behaviours. As this is an open pilot trial, there is no comparison group. All participants will have the opportunity to participate in the group therapy intervention. Participants will be asked to take part in four assessment visits: screening (Day 1), baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21). The intervention under investigation is a 6-week group therapy intervention consisting of weekly 2-hour sessions delivered via video conferencing, with weekly home practice assignments delivered and completed remotely.
Eligibility Criteria
Inclusion Criteria: 1. Above the age of 18. 2. Diagnosis of SSD (i.e., Schizophrenia, Schizophreniform, Schizoaffective Disorder, or Delusional Disorder), confirmed based on self-report. 3. Have current symptoms related to psychosis (as determined by a score of 2 or higher on the SAPS). 4. Engaged in current outpatient treatment for psychosis (e.g., medication management by psychiatrist or general practitioner, case management, community mental health treatment, etc.). 5. Has or has access to personal technology (e.g., smartphone, tablet, or laptop/computer) with access to wifi or cellular data. Exclusion Criteria: 1. Not capable of providing informed consent (see Consent Procedures). 2. Does not have an SSD diagnosis. 3. Does not experience current delusions. 4. Not currently involved in outpatient treatment. 5. Is currently receiving CBTp. 6. Does not own or have access to personal technology (e.g., smartphone, tablet, or laptop/computer) with access to wifi or cellular data.
Contact & Investigator
Micheal W Best, PhD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT07569471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia Spectrum & Other Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07569471 currently recruiting?
Yes, NCT07569471 is actively recruiting participants. Contact the research team at jessica.darcey@mail.utoronto.ca for enrollment information.
Where is the NCT07569471 trial being conducted?
This trial is being conducted at Scarborough Village, Canada.
Who is sponsoring the NCT07569471 clinical trial?
NCT07569471 is sponsored by University of Toronto. The principal investigator is Micheal W Best, PhD at University of Toronto. The trial plans to enroll 38 participants.
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