The Personalized Psychological Treatment for Psychosis (PERMEPSY)

Polish Academy of Sciences

Status: Not yet enrolling

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Psychosis; Schizophrenia

Treatments: Behavioral: Psychological treatment (MCT); Behavioral: Psychological treatment (P-MCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06603922

PerMed/V/82/PERMEPSY/2023

Details and patient eligibility

About

The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.

Full description

This prospective study will consist of a pilot, double-blind clinical trial comparing Personalized MCT (P-MCT) to classical MCT. This pilot study will serve as a basis to validate the profiling strategy of patients and to test whether a personalized approach to psychological interventions (P-MCT) is more effective than non-personalized interventions (classical MCT).

The experimental intervention will be P-MCT. Baseline data of the patients randomized to the P-MCT and classical MCT group will be entered into the prototype platform, which will output the patient's profile and an estimate of response to MCT and the specific homeworks to be included in the intervention. MCT dedicates one session to attributional biases, two to Jumping to Conclusions Bias, one to belief change, two to empathy, one to meta-memory, and one to self-esteem and two additional for self-esteem and stigma. The personalized MCT will have personalized homeworks that target specific factors, in which patients have deficits. For instance, patients with deficits in self-esteem (based on the results from the platform) will be provided with homework addressing this aspect. We identified five domains that will be personalized: 1. self-esteem; 2. cognitive insight; 3. delusions; 4. positive symptoms; 5. completion.

All interventions will be conducted by psychologists or mental-health professionals trained in MCT. All the treatments will be conducted on-site and online. Both conditions patients will receive 10 sessions of MCT. Control intervention: The control group is an active group that will receive classical MCT for psychosis following the current program. Duration of intervention per patient: 10 weeks (1 session per week of one hour of length). Patients will be assessed at baseline, post-treatment, and 6-month follow up.

The sample will include patients with Schizophrenia Spectrum Disorders (n=252) from five clinical center (Poland, Germany, France, Chile and Spain).

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.
2. Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity >=3).
3. Adults, 18 - 65 years of age
4. Stable condition with no expected changes in medication (information from clinical services).
5. Lack of severe cognitive deficits (global assessment or/and information from clinical services);

Exclusion criteria

1. Having received MCT in the previous year.
2. Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and/or other sources);
3. A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
4. aggressive behavior (reports from clinical services if available)
5. High risk of suicide (verified with DIAMOND)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

Personalized MCT (P-MCT)

Experimental group

Description:

Personalized Metacognitive training

Treatment:

Behavioral: Psychological treatment (P-MCT)

Metacognitive training (MCT)

Active Comparator group

Description:

Metacognitive training

Treatment:

Behavioral: Psychological treatment (MCT)