PsychosisNCT06703827
Effects of Online Metacognitive Training Group on Distressing Beliefs
A study testing The metacognitive training group in people with Psychosis, run by City, University of London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- The metacognitive training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2024to 27 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Kent and Medway NHS and Social Care Partnership Trust
Maidstone, Kent, ME16 9PH
Lyndsey Hurcomb, +4401622427201, lyndsey.hurcomb@nhs.net
Kasia Wawrzyniak
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- The metacognitive training group
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The metacognitive training groupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
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).
Measured: 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.
Measured: 1 week pre-intervention and 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Apr 2024
- Primary completion27 Jul 2025 (estimated)
- Study completion27 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasia Wawrzyniak, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703827
- Sponsor's protocol ID
- 323885
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD will only be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Online MCT Group on Persecutory Delusions and Cognitive Biases in Clients with First Episode of Psychosis.
- ClinicalTrials.gov ID
- NCT06703827
- Acronym / sponsor ID
- 323885
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 27 Jul 2025 (estimated)
- Study completion
- 27 Sep 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MCT group | Experimental | Behavioral: The metacognitive training groupOnline 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The metacognitive training groupThe 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. | Behavioural | MCT group |
Primary outcome
The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999)
Time frame: 1 week pre intervention and 1 week post-intervention
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).
The Cognitive Biases Questionnaire for Psychosis (CBQp), developed by Peters et al. (2014)
Time frame: 1 week pre-intervention and 1 week post-intervention
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.
The Positive and Negative Syndrome Scale (PANSS)
Time frame: 1 week pre-intervention and 1 week post-intervention
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).
The Revised Green et al. Paranoid Thoughts Scale - 18 items (R-GPTS; Freeman et al., 2019)
Time frame: 1 week pre-intervention and 1 week post-intervention
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.
The Fast and Slow Thinking Questionnaire (FAST, Hardy et al., 2020)
Time frame: 1 week pre-intervention and 1 week post-intervention
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.
Delusional conviction will be self-rated weekly post each MCT Module using a visual scale (adapted from Freeman et al.'s RCT, 2021)
Time frame: 1 week pre-intervention, weekly questionnaires over 10 weeks after each intervention, and 1 week post-intervention
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).
2 secondary outcomes
The Clinical Outcomes in Routine Evaluation (CORE-OM 34; Evans et al., 2002)
Time frame: 1 week pre-intervention and 1 week post-intervention
The CHOICE short form measure (Greenwood et al., 2010)
Time frame: 1 week pre-intervention and 1 week post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes. Anonymized IPD will only be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasia Wawrzyniak principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The metacognitive training group in people with Psychosis, run by City, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasia Mrs Wawrzyniak (+447500765884, kasia.wawrzyniak@city.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999) (time frame: 1 week pre intervention and 1 week post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.