UnknownNot Applicable

Effects of Online Metacognitive Training Group on Distressing Beliefs

United Kingdom72 participantsStarted 2024-04-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999)

Timeframe: 1 week pre intervention and 1 week post-intervention

The Cognitive Biases Questionnaire for Psychosis (CBQp), developed by Peters et al. (2014)

Timeframe: 1 week pre-intervention and 1 week post-intervention

The Positive and Negative Syndrome Scale (PANSS)

Timeframe: 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)

Timeframe: 1 week pre-intervention and 1 week post-intervention

The Fast and Slow Thinking Questionnaire (FAST, Hardy et al., 2020)

Timeframe: 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)

Timeframe: 1 week pre-intervention, weekly questionnaires over 10 weeks after each intervention, and 1 week post-intervention

Trial details

NCT IDNCT06703827

SponsorCity, University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-27

Contact for this trial

Kasia Mrs Wawrzyniak

+447500765884 kasia.wawrzyniak@city.ac.uk

View on ClinicalTrials.gov More Psychosis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999)

Timeframe: 1 week pre intervention and 1 week post-intervention

The Cognitive Biases Questionnaire for Psychosis (CBQp), developed by Peters et al. (2014)

Timeframe: 1 week pre-intervention and 1 week post-intervention

The Positive and Negative Syndrome Scale (PANSS)

Timeframe: 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)

Timeframe: 1 week pre-intervention and 1 week post-intervention

The Fast and Slow Thinking Questionnaire (FAST, Hardy et al., 2020)

Timeframe: 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)

Timeframe: 1 week pre-intervention, weekly questionnaires over 10 weeks after each intervention, and 1 week post-intervention