Clinical trial NCT06703827: Effects of Online Metacognitive Training Group on Distressing Beliefs
Official title: Effects of the Online MCT Group on Persecutory Delusions and Cognitive Biases in Clients with First Episode of Psychosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: City, University of London
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Psychotic Symptom Rating Scales (PSYRATS) created by Haddock et al. (1999)
timeFrame: 1 week pre intervention and 1 week post-intervention
measure: The Cognitive Biases Questionnaire for Psychosis (CBQp), developed by Peters et al. (2014)
timeFrame: 1 week pre-intervention and 1 week post-intervention
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: 1 week pre-intervention and 1 week post-intervention
measure: 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
measure: The Fast and Slow Thinking Questionnaire (FAST, Hardy et al., 2020)
timeFrame: 1 week pre-intervention and 1 week post-intervention
measure: Delusional conviction will be self-rated weekly post each MCT Module using a visual scale (adapted from Freeman et al.&#39;s RCT, 2021)
timeFrame: 1 week pre-intervention, weekly questionnaires over 10 weeks after each intervention, and 1 week post-intervention
Secondary outcomes:
measure: The Clinical Outcomes in Routine Evaluation (CORE-OM 34; Evans et al., 2002)
timeFrame: 1 week pre-intervention and 1 week post-intervention
measure: The CHOICE short form measure (Greenwood et al., 2010)
timeFrame: 1 week pre-intervention and 1 week post-intervention
Other outcomes:
Locations:
city: Maidstone
country: United Kingdom
facility: Kent and Medway NHS and Social Care Partnership Trust
state: Kent
Study officials:
affiliation: City, University of London
name: Kasia Wawrzyniak
role: PRINCIPAL_INVESTIGATOR
References: