REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Toronto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
Other interventionREFLECT 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Active Group TherapyExperimental treatment 1 intervention
Trial outcomes
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.
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).Secondary outcomes
1
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.
Time frame
The SAPS is administered at screening (Day 1), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).2
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.
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).3
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.
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).4
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.
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).Other outcomes
1
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.
Time frame
The USE Questionnaire is administered once at the end of the study (at 3-month follow-up visit; Weeks 19-21).2
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.
Time frame
STTS-R is administered once post-intervention (Weeks 7-9).Sponsors and contacts
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Source ClinicalTrials.gov