Effects of Online Metacognitive Training Group on Distressing Beliefs

Effects of the Online MCT Group on Persecutory Delusions and Cognitive Biases in Clients with First Episode of Psychosis.

Psychosis is characterized by distorted perceptions of reality, often involving persecutory delusions. Research links these symptoms to cognitive biases like "jumping to conclusions." Despite mixed reviews of Cognitive Behavioral Therapy (CBTp) for psychosis, a study will explore metacognitive training (MCT) delivered online. This training will be tested over 10 weeks with participants from a psychosis service in Kent, assessing its effect through interviews and questionnaires before and after the program, focusing on symptom improvement and cognitive changes.

Study Overview

• Status: Recruiting
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: The metacognitive training group

Detailed Description

Psychosis is described as disruptions to a person's beliefs and view of the world that make it challenging for them to establish what is a reality. Some people with psychosis experience persecutory delusions, which is a distressing belief that harm will happen to them by others.

Research indicated that certain errors in thinking (called cognitive biases, e.g.: jumping to conclusions) have been linked to psychotic symptoms in at high risk from psychosis. Studies reveal that certain errors in thinking may be causal factors for the development and maintenance of delusions.

National Institute of Health and Care Excellence recommends psychological interventions such as Cognitive Behavioural Therapy for a Psychosis (CBTp), but the efficacy of CBTp has been questioned, and small uptake by clients has also been discovered. This research is based on the metacognitive training delivered in groups, which is a psycho-educational programme targeting these thinking errors in psychosis. Research indicates that this training can be delivered online in a group to participants with psychosis, hence it offered a promising treatment approach in times of pandemic.

The participants will be recruited from an Early Intervention in Psychosis service in Kent and will take part in a ten week MCT or Treatment as Usual (TAU). The MCT will consist of spending 90 minutes a week in a small online group setting working through a series of workshops. Participants will also be asked to complete homework each week and they will be supported with this. Interviews and questionnaires regarding symptoms and thinking errors will be used before and immediately after the intervention. The participants who attended the group and improved in their symptoms and thinking errors will be invited to an interview asking them what worked for them and how they found the group.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kasia Mrs Wawrzyniak; Phone Number: +447500765884; Email: kasia.wawrzyniak@city.ac.uk
• Study Contact Backup: Name: Anne-Kathrin Fett, Dr; Phone Number: +4402070400541; Email: anne-kathrin.fett@city.ac.uk

Study Locations

• United Kingdom
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9PH
      • Recruiting
      • Kent and Medway NHS and Social Care Partnership Trust
      • Contact: Lyndsey Hurcomb; Phone Number: +4401622427201; Email: lyndsey.hurcomb@nhs.net
      • Contact: Kasia Wawrzyniak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

New inclusion criteria (after amendment):

• participants who have a diagnosis of a first episode of psychosis, schizophrenia spectrum, affective disorder with psychotic symptoms;
• all participants will need to score 3 or above on PANSS delusions (PANSS, Kay et al., 1987)
• are of age 18-65 years;
• are conversant in English and able to read in English;

New exclusion criteria (after amendment)

• current inpatient admission;
• below 18 years of age;
• moderate to severe learning disability;
• severe organic impairment;
• severe substance use disorder;
• inability to speak and write fluently in English (hindering their ability to complete standardized assessments and fully participate in the intervention).
• currently taking part in any other interventional research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCT group; Online MCT group (10 sessions) will be delivered by colleague CBT therapist (with previous experience of delivering MCT group) and assistant psychologist/clinical associate psychological practitioner, where all professionals will receive appropriate training by chief investigator. The group will also have one expert patient who attended the previous pilot group (at The NHS Trust) and is willing to help conduct the current MCT training. All psychology staff have experience in delivering psychological therapies and working with psychosis. The study will use qualitative data to refine the results of the quantitative findings by using follow-up semi-structured interviews to better understand the participants' experiences who had a minimum of 40% reduction of their persecutory delusions and/or cognitive biases and/or secondary measures (CHOICE and CORE-OM 34). The interviews will be conducted immediately post-intervention.	Behavioral: The metacognitive training group; The MCT will consist of spending 90 minutes a week in a small online group setting working through a series of workshops. Participants will also be asked to complete homework each week and they will be supported with this. Interviews and questionnaires regarding symptoms and thinking errors will be used before and immediately after the intervention. The participants who attended the group and improved in their symptoms and thinking errors will be invited to an interview asking them what worked for them and how they found the group.
No Intervention: Treatment as Usual Group (TAU); TAU group: Treatment as usual is the general treatment protocol for patients with first episode of psychosis in the Early Intervention in Psychosis Service, where most patients have antipsychotic medication and at least monthly contact with care coordinator, and at least 6 monthly outpatient appointment with a psychiatrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999)	This scale to measures delusional beliefs and auditory hallucinations. The scale has demonstrated excellent inter-rater, test-retest reliability (Haddock et al 1999). Furthermore, its validity has been established through research on individuals experiencing a first episode of psychosis (Drake et al., 2007).	1 week pre intervention and 1 week post-intervention
The Cognitive Biases Questionnaire for Psychosis (CBQp), developed by Peters et al. (2014)	It evaluates specific cognitive biases such as catastrophizing, dichotomous thinking, emotional reasoning, and jumping to conclusions by using thirty vignettes that depict everyday life scenarios. Participants are asked to rate the scenarios based on four response options. Peters et al. (2014) have determined that this questionnaire has good reliability and concurrent validity.	1 week pre-intervention and 1 week post-intervention
The Positive and Negative Syndrome Scale (PANSS)	This is demonstrated in various studies such as Moritz et al. (2011), Favrod et al. (2014), Moritz et al. (2013), and Briki et al. (2014). The PANSS is a 30-item interview assessment tool designed to evaluate the intensity of psychotic symptoms and has demonstrated high interrater reliability (Kay et al., 1987).	1 week pre-intervention and 1 week post-intervention
The Revised Green et al. Paranoid Thoughts Scale - 18 items (R-GPTS; Freeman et al., 2019)	It is an outcome measure that is used to assess the presence and severity of paranoid thoughts. It consists of 18 items and was revised by Freeman et al. in 2019. The R-GPTS is used to assess the severity of paranoid thoughts in individuals with a range of mental health conditions such as paranoia and schizophrenia. The results of the studies conducted by Freeman et al. (2019) provide evidence for the validity and reliability of the R-GPTS as a measure of paranoid thoughts. These findings suggest that the R-GPTS can be used with confidence in clinical and research settings to accurately assess the presence and severity of paranoid thoughts.	1 week pre-intervention and 1 week post-intervention
The Fast and Slow Thinking Questionnaire (FAST, Hardy et al., 2020)	It is a measure of reasoning biases in individuals with paranoid thoughts. The study by Hardy et al. (2020) showed that the FAST has good internal consistency and test-retest reliability. The FAST scores were significantly associated with other measures of paranoid thoughts and were able to differentiate between individuals with high and low levels of paranoia, demonstrating its concurrent and discriminant validity. These findings suggest that the FAST is a reliable and valid tool for assessing reasoning biases in individuals with paranoia.	1 week pre-intervention and 1 week post-intervention
Delusional conviction will be self-rated weekly post each MCT Module using a visual scale (adapted from Freeman et al.'s RCT, 2021)	Scale will ask respondents to state how strongly they believe their persecutory belief, ranging from 0 (no conviction in belief) to 100 conviction (total conviction in belief). Level of happiness will be self-rated weekly after each MCT Module using a visual scale that will ask respondents how happy they feel, ranging from 0 (not at all) to 100 (very much).	1 week pre-intervention, weekly questionnaires over 10 weeks after each intervention, and 1 week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Clinical Outcomes in Routine Evaluation (CORE-OM 34; Evans et al., 2002)	It is a widely used measure of distress in the psychology department's Early Intervention for Psychosis Service, where the researcher will conduct the study. The highest possible score on the questionnaire is 136, which indicates extreme levels of distress. It has been established as a valid measure with robust outcomes (Evans et al., 2002).	1 week pre-intervention and 1 week post-intervention
The CHOICE short form measure (Greenwood et al., 2010)	It evaluates psychological recovery and has demonstrated strong psychometric properties. It is also regularly utilized in the local Trust and service. This questionnaire assesses changes within CBTp and may also be useful in measuring outcomes of MCT.	1 week pre-intervention and 1 week post-intervention

Collaborators and Investigators

• Sponsor: City, University of London
• Investigators: Principal Investigator: Kasia Wawrzyniak, City, University of London

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): July 27, 2025
• Study Completion (Estimated): September 27, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 323885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized IPD will only be shared
• IPD Sharing Time Frame: Anticipated January 2025 till 30.09.2025
• IPD Sharing Access Criteria: Via University email, requests will be discussed with academic supervisor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No