Effects of Online Metacognitive Training Group on Distressing Beliefs

NCT ID: NCT06703827

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2025-09-27

Brief Summary

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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

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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

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

The metacognitive training group

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kasia Wawrzyniak

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Locations

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Kent and Medway NHS and Social Care Partnership Trust

Maidstone, Kent, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Kasia Mrs Wawrzyniak

Role: CONTACT

+447500765884

Anne-Kathrin Fett, Dr

Role: CONTACT

+4402070400541

Facility Contacts

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Lyndsey Hurcomb

Role: primary

+4401622427201

Kasia Wawrzyniak

Role: backup

Other Identifiers

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323885

Identifier Type: -

Identifier Source: org_study_id

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