Schizophrenia Spectrum & Other Psychotic DisordersREFLECTNCT07569471
REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis
A study testing REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time in people with Schizophrenia Spectrum & Other Psychotic Disorders, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Spectrum & Other Psychotic Disorders
- What is being tested?
- REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto Scarborough
Scarborough Village, Ontario, M1C 1A4
Jessica D'Arcey, PhD Candidate, 647-689-6098 ext. ext. 108, reflectstudy.utsc@utoronto.ca
About this study
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:
Read more
- Is targeting core beliefs in a technology-supported remote group therapy format safe and feasible?
- 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.
- Being tested
- REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
- Keywords
- Psychosis, Cognitive Behavioural Therapy, Group Therapy, Remote Therapy, Online Therapy, Schizophrenia, Schizoaffective Disorder
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real TimeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A validated and widely used clinician-rated interview that includes subscales on hallucinations, delusions, and disorganized behaviour and thought disorder. Higher scores on this scale indicate greater symptom severity or intensity. Scores range from 0-170.
Measured: 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 a validated and widely used clinician-rated interview that measures the severity and impact of hallucinations and delusions (subscales). Higher scores indicate more impact on the individual and a higher symptom severity. Scores on the auditory hallucination subscale range from 0-44 and 0-24 on the delusion subscale, with a total score range from 0-68.
Measured: 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
This is a clinician-rated interview that assesses the severity of negative symptoms. Higher scores indicate greater severity of negative symptoms. There are four subscales: Affective Flattening, Alogia, Avolition, and Anhedonia. Total scores range from 0-95.
Measured: 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 a validated self-report measure examining a particular type of biased thinking known as referential thinking. The scale includes 34 True-False questions, with a total score ranging from 0-34. Higher scores on this scale indicate higher endorsement of referential thinking.
Measured: 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 Decentering Scale is a self-report measure of self-referential interpretations/biases and the ability to decenter. Higher scores indicate greater ability to decenter. Individual items are rated on a scale from 1 to 5, with total scores ranging from 11-55.
Measured: 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).
Davos Assessment of the Cognitive Biases Scale
The DACOBS is a validated and widely used self-report measure used to quantify endorsement of different types of cognitive biases and safety behaviours. Higher scores indicate higher endorsement of these biases or thinking patterns. The following are the subscales and their score ranges. Cognitive Biases Subscales: Jumping to conclusions bias (7-42), Belief Inflexibility bias (7-42), Attention for Threat bias (7-42), External Attribution bias (7-42), and Total Cognitive Bias Score (28-168). Cognitive Impairment Subscales: Social Cognition problems (7-42), Subjective Cognitive problems (7-42), and Total Cognitive Problems (14-84). Safety Behaviours Subscale (7-42).
Measured: The DACOBS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Aberrant Salience Inventory
The ASI is a validated self-report inventory that measures a neurocognitive bias known as aberrant salience. Higher scores on this scale indicate higher endorsement of experiences related to aberrant salience. Total scores range from 0-29.
Measured: The ASI is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Recovery Assessment Scale
The RAS is a validated self-report measure quantifying endorsement of experiences related to personal recovery. Higher scores on this scale indicate more endorsement of personal recovery. Over time, increasing scores would indicate improvements in personal recovery. Total scores range from 41-205.
Measured: The RAS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start31 Mar 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum & Other Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Best, University of Toronto
- Investigators
- Micheal W Best, PhD, Principal investigator, University of TorontoSean A Kidd, PhD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569471
- Sponsor's protocol ID
- 48596
- Acronym
- REFLECT
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis
- ClinicalTrials.gov ID
- NCT07569471
- Acronym / sponsor ID
- REFLECT / 48596
- Keywords
- Psychosis, Cognitive Behavioural Therapy, Group Therapy, Remote Therapy, Online Therapy, Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is targeting core beliefs in a technology-supported remote group therapy format safe and feasible?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Group Therapy | Experimental | Other: REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real TimeAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real TimeREFLECT 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. | Other | Active Group Therapy |
Primary outcome
Brief Core Schema Scale
Time frame: 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).
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.
8 secondary outcomes
Scale for the Assessment of Positive Symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Davos Assessment of the Cognitive Biases Scale
Time frame: The DACOBS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Aberrant Salience Inventory
Time frame: The ASI is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Recovery Assessment Scale
Time frame: The RAS is administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Micheal W Best, PhD principal investigator
University of Toronto
Sean A Kidd, PhD study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time in people with Schizophrenia Spectrum & Other Psychotic Disorders, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica D'Arcey, PhD Candidate (647-689-6098 ext. ext. 108, jessica.darcey@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Core Schema Scale (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.