| Registry | NCT07569471, acronym REFLECT |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 38 (Estimated) |
| Sponsor | University of Toronto (Other) |
| Conditions | Schizophrenia Spectrum & Other Psychotic Disorders |
| Interventions | REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time (Other) |
| Dates | start 2026-03-31, primary completion 2027-08-30 (estimated), completion 2028-01-30 (estimated), first posted 2026-05-06, last updated 2026-05-06 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia Spectrum & Other Psychotic Disorders All trials of REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active Group Therapy | Experimental | Other: REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Toronto Scarborough | Scarborough Village, Ontario | Canada | Recruiting |