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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The SAPS is administered at screening (Day 1), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21). |
| Measure | Description | Time Frame |
|---|---|---|
| Usefulness, Satisfaction, and Ease of Use Questionnaire | The USE Questionnaire is a self-report survey that allows participants to provide feedback on the technology used in the project (i.e., video conferencing, remote homework completion). Total scores range from 18-90 with higher scores indicating better satisfaction. | The USE Questionnaire is administered once at the end of the study (at 3-month follow-up visit; Weeks 19-21). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica D'Arcey, PhD Candidate | Contact | 647-689-6098 | ext. 108 | jessica.darcey@mail.utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Micheal W Best, PhD | University of Toronto | Principal Investigator |
| Sean A Kidd, PhD | University of Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toronto Scarborough | Recruiting | Scarborough Village | Ontario | M1C 1A4 | Canada |
Data will be available upon reasonable request.
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|
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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). |
| Satisfaction With Therapy and Therapist Scale-Revised | This self-report survey allows participants to provide feedback about the group therapy and group therapy facilitators. Total scores range from 12-60, with higher scores indicating higher satisfaction. The last item asks participants for an overall rating from 1-5 on how much the therapy helped them. | STTS-R is administered once post-intervention (Weeks 7-9). |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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