Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603922
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
The Personalized Psychological Treatment for Psychosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERMEPSY
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 trialWe 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 patients 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 n252 from five clinical center Poland Germany France Chile and Spain
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 patients 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 n252 from five clinical center Poland Germany France Chile and Spain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None