38 Participants NeededMy employer runs this trial

Compassion-Focused Cognitive Behavioural Therapy for Psychosis

(REFLECT Trial)

JD
Overseen ByJessica D'Arcey, PhD Candidate
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

MW

Micheal W Best, PhD

Principal Investigator

University of Toronto

SA

Sean A Kidd, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

Inclusion Criteria

I am over 18 years old.
I am currently receiving outpatient treatment for psychosis.
5. Has or has access to personal technology (e.g., smartphone, tablet, or laptop/computer) with access to wifi or cellular data.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Baseline

Pre-intervention assessments are conducted

2 weeks
1 visit (in-person)

Treatment

Participants undergo a 6-week group therapy intervention with weekly 2-hour sessions delivered via video conferencing

6 weeks
6 visits (virtual)

Post-intervention

Assessments conducted to evaluate changes post-treatment

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • REFLECT

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active Group TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Recruited
1,125,000+