REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis

Обзор

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.

Вмешательства

• Другое REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
  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 C

Первичные конечные точки

• Brief Core Schema Scale [Срок оценки: 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).]

Вторичные конечные точки (8)

• Scale for the Assessment of Positive Symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Toronto Scarborough — Scarborough Village

Идентификаторы

NCT: NCT07569471 · 48596

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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