REFLECT: A Novel Group-Based Compassion-Focussed Cognitive Behavioural Approach to Core Beliefs in Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Brief Core Schema Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above the age of
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Group Therapy
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.
干预措施: REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time (Other)
结局指标
主要结局
Brief Core Schema Scale
时间窗: 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.
次要结局
- Scale for the Assessment of Positive Symptoms(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 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(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 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 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 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 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 administered at baseline (pre-intervention; Day 1-14), post-intervention (Weeks 7-9), and a three-month follow-up (Weeks 19-21).)
研究者
Michael Best
Assistant Professor
University of Toronto