Effects of Online Metacognitive Training Group on Distressing Beliefs

NCT06703827 | Recruiting

• 1 other identifier: 323885
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• The Clinical Outcomes in Routine Evaluation (CORE-OM 34; Evans et al., 2002)

  1 week pre-intervention and 1 week post-intervention

• The CHOICE short form measure (Greenwood et al., 2010)

  1 week pre-intervention and 1 week post-intervention

Study Arms (2)

MCT group

EXPERIMENTAL

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

Treatment as Usual Group (TAU)

NO INTERVENTION

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.

Interventions

The metacognitive training group BEHAVIORAL

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.

MCT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• City, University of London: lead

Study Sites (1)

Kent and Medway NHS and Social Care Partnership Trust

Maidstone, Kent, ME16 9PH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Kasia Wawrzyniak

  City, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasia Mrs Wawrzyniak

CONTACT

+447500765884; kasia.wawrzyniak@city.ac.uk

Anne-Kathrin Fett, Dr

CONTACT

+4402070400541; anne-kathrin.fett@city.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The chief investigator will be responsible for administering baseline outcome measures but not facilitating the MCT group sessions to minimize the potential for bias. Consequently, the assessment after the intervention will be performed in a fully blind manner. Participants will be reminded not to reveal their group status to the post-intervention assessor in order to maintain the blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is an experimental, multi-centre trial aiming to investigate the impact of online MCT group on participants' persecutory delusions and cognitive biases in Early Intervention for Psychosis Service in Kent. Participants will be allocated randomly to either MCT group or Treatment as Usual Group (TAU) and these two groups will be compared to each other. This study will use an online survey called Qualtrics (Qualtrics, Provo, UT) that will include quantitative measures that participants will be asked to complete.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: November 25, 2024
• Study Start: April 26, 2024
• Primary Completion: July 27, 2025
• Study Completion: September 27, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anticipated January 2025 till 30.09.2025
• Access Criteria: Via University email, requests will be discussed with academic supervisor

Locations

GB (1)