Clinical trial NCT06603922: The Personalized Psychological Treatment for Psychosis
Official title: Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Psychosis
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: personalized medicine
psychological treatment
metacognitive training
machine learning
software platform
Lead sponsor: Polish Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Fundació Sant Joan de Déu
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospitals of Strasbourg
name: Universitat Politècnica de Catalunya
name: Universidad de Valparaiso
First posted: 2024-09-19
Enrollment: 252
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 sample will be randomized into P-MCT or classical MCT in a RCT where the user's participants (patients diagnosed with non-affective psychoses) and evaluators will be blind to the treatment condition.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Sociodemographic Questionnaire
timeFrame: Baseline
measure: PSYRATS
timeFrame: baseline, post-treatment and 6-month follow-up
measure: PANSS
timeFrame: baseline, post-treatment and 6-month follow-up
measure: RSES
timeFrame: baseline, post-treatment and 6-month follow-up
measure: BCIS
timeFrame: baseline, post-treatment and 6-month follow-up
Secondary outcomes:
measure: GAF
timeFrame: baseline, post-treatment and 6-month follow-up
measure: DIAMOND
timeFrame: baseline
measure: WHOQOL-BREF
timeFrame: baseline, post-treatment and 6-month follow-up
measure: TEC
timeFrame: baseline
measure: CBQp
timeFrame: baseline, post-treatment and 6-month follow-up
measure: ISMI
timeFrame: baseline, post-treatment and 6-month follow-up
measure: QSLE-SV
timeFrame: baseline, post-treatment and 6-month follow-up
measure: RFQ
timeFrame: baseline, post-treatment and 6-month follow-up
measure: ISI
timeFrame: baseline, post-treatment and 6-month follow-up
measure: SUMD
timeFrame: baseline, post-treatment and 6-month follow-up
measure: B-IRI
timeFrame: baseline, post-treatment and 6-month follow-up
measure: BHS
timeFrame: baseline, post-treatment and 6-month follow-up
measure: PHQ-9
timeFrame: baseline, post-treatment and 6-month follow-up
measure: IPSAQ
timeFrame: baseline, post-treatment and 6-month follow-up
measure: Satisfaction with MCT treatment
timeFrame: post-treatment
measure: TMT
timeFrame: baseline, post-treatment and 6-month follow-up
measure: Fish Task
timeFrame: baseline, post-treatment and 6-month follow-up
measure: BCFT
timeFrame: baseline, post-treatment and 6-month follow-up
measure: The Hinting Task
timeFrame: baseline, post-treatment and 6-month follow-up
measure: Monitoring symptoms during MCT
timeFrame: post-treatment
Other outcomes:
Locations:
city: Valparaíso
country: Chile
facility: Universidad de Valparaíso
city: Strasbourg Cedex
country: France
facility: University Hospitals of Strasbourg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Warsaw
country: Poland
facility: The Institute of Psychology, The Polish Academy of Sciences
city: Barcelona
country: Spain
facility: Universitat Politècnica de Catalunya
state: Catalonia
city: Barcelona
country: Spain
facility: Fundació Sant Joan de Déu
Study officials:
affiliation: The Institute of Psychology, Polish Academy of Sciences
name: Łukasz Gawęda, Professor
role: PRINCIPAL_INVESTIGATOR
References: