Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423651
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-16
Brief Title:
Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders
Sponsor:
Universitat Autonoma de Barcelona
Organization:
Universitat Autonoma de Barcelona
Study Overview
Official Title:
Benefits of Combining Metacognitive Training MCT With Cognitive Remediation CR in the Recovery of Patients With Psychotic Spectrum Disorders CRMCTp
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRMCTp
Brief Summary:
The goal of this clinical trial is to compare the efficacy of combined REHACOP MCT alone in persons with nonaffective psychotic disorder in terms of recovery The main questions it aims to answer are
Does combined REHACOP MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder compared to MCT alone
What is the impact of combined REHACOP MCT therapy compared to MCT therapy alone on personalpsychological recovery cognitive biases and social cognition taking gender differences into account
What is the durability of the effects of combined REHACOP MCT therapy compared to MCT therapy alone on clinical recovery personal recovery cognitive biases and social cognition in the long term
Researchers will compare REHACOPMCT therapy to MCT alone to see if there are differences in personalpsychological recovery
Participants will
Participate in Metacognitive Training or in combined REHACOP Metacognitive training therapy
Do 8 weekly sessions of 45-60 minutes MCT group
Do 12 weekly sessions of 45-60 minutes RECHACOPMCT group
Visit the clinic for checkups and tests
Answer self-administered tests
Does combined REHACOP MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder compared to MCT alone
What is the impact of combined REHACOP MCT therapy compared to MCT therapy alone on personalpsychological recovery cognitive biases and social cognition taking gender differences into account
What is the durability of the effects of combined REHACOP MCT therapy compared to MCT therapy alone on clinical recovery personal recovery cognitive biases and social cognition in the long term
Researchers will compare REHACOPMCT therapy to MCT alone to see if there are differences in personalpsychological recovery
Participants will
Participate in Metacognitive Training or in combined REHACOP Metacognitive training therapy
Do 8 weekly sessions of 45-60 minutes MCT group
Do 12 weekly sessions of 45-60 minutes RECHACOPMCT group
Visit the clinic for checkups and tests
Answer self-administered tests
Detailed Description:
This project is aimed at responding to one of the Challenges of the Spanish Strategy for Science Technology and Innovation specifically Challenge 1 Health demographic change and well-being One of the work areas that are located within this challenge is the Clinical and Translational Research based on the evidence of scientific and technological knowledgeThe present proposal is clearly within the framework of clinical-translational investigation since most of the entities participating attend persons with psychotic disorders thereby ensuring the translation of investigation to the clinical setting In addition this project includes investigators with wide experience in psychological interventions in the target population and with previous experience in investigation in this area Lastly it is of note that the benefits of this investigation are not only of a scientific nature but also involve clinical investigation with a direct repercussion on improvement in the health care of people with psychotic disorders enabling the design of new strategies of psychological interventions Besides the present proposal is aimed at responding to the challenges of our society contributing to covering the needs of persons with psychotic disorder as well as developing the most effective therapeutic strategies to improve aspects related to clinical and personal recovery Specifically this project will allow making changes that will improve the quality of health care to the target population incorporating the combinated use of scientifically proven therapeutic strategies to health care services In short this project aims to promote innovation in the provision of mental health services being the starting point in analyzing the efficacy of combined psychological therapies versus monotherapies address to improve of metacognitive processes
- General and specific objectives General objective Compare the efficacy of combined REHACOP MCT therapy vs MCT alone in persons with nonaffective psychotic disorder in terms of recovery
Specific objectives
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on clinical recovery clinical remission and functional recovery the latter understood in terms of cognitive occupational and social functioning
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on personalpsychological recovery
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on cognitive biases and social cognition
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone according to gender
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone according to self-esteem quality of life and stigma
Evaluate the maintenance of the effects of combined REHACOP MCT therapy vs MCT alone on clinical recovery personal recovery cognitive biases and social cognition in the long term
Methodology
Design
This will be a randomised clinical trial in which one group will receive combined REHACOP MCT therapy and another group will receive therapy with MCT alone The metacognitive treatment will have the same characteristics in the two treatment conditions Randomisation of the patients for receiving one of the two treatments will be carried out using a random number list based on the order of access to their reference centre The evaluator will be blinded to the treatment group to which the patient assessed belongs
Study subjects The sample will be made up of people with non-affective psychotic disorder who are attended in any of the centres participating in the study which belong to the following entitiesConsorci Sanitari de Terrassa Hospital de Mataró Instituto de Investigación Biomédica de Gerona IdIBG Parc Sanitari Sant Joan de Déu Asociación Centro de Higiene Mental Les Corts Hospital Sierrallana-Tres Mares and UGC Salud Mental de Jaén
Sample size Considering that the investigators have no preliminary data on our principal objective in relation to clinical and personal recovery the score obtained in the global assessment of functioning GAF at follow-up will be taken as a measure of outcome since it is implicated in both clinical and functional recovery The investigators used the data published in the article by Ochoa et al 2017 in order to calculate the required sample size for this study In this article a difference of means of 573 points SD1151 is obtained in the GAF scale from baseline and the follow-up at 6 months after the intervention With these data the necessary sample size has been estimated with an alpha of 005 and a power of 08 Taking into account 20 of possible losses to follow-up the sample size has been calculated as 160 cases 80 in each experimental arm REHACOP MCT vs MCT In this way taking into account that the intervention groups will be carried out in the health care centers of 7 different entities each will have to recruit 24 patients 12 for each experimental condition
Data collection the professional who makes the referral of the patients to the study will be responsible for reviewing fulfillment of the inclusion and exclusion criteria Patients fulfilling the inclusion criteria will receive an explanation of the study and if they accept to participate they must provide signed informed consent The evaluation will be carried out at 3 time points T0 basal assessment prior to initiation of treatment All the previously described scales will be administered T1 post-treatment evaluation all the scales will be administered and in addition the satisfaction perceived with the interventions received will be evaluated T2 follow-up evaluation at 6 months after completing the intervention all the scales will again be administered In addition the number of relapses and hospitalizations during the time interval will be registered Assessment of the PANSS and GAF should take into account the temporal criterium mentioned in the section of Outcomes A contingency plan will be considered in the event that difficulties are detected in carrying out any of the phases of the study due to external causes such as the continuity of the COVID-19 pandemic This plan will consist of the implementation of interventions and evaluations making use of new technologies All the centers already have the adequate infrastructure to carry out the project under these conditions
Data analysis Firstly the two groups will be compared with the aim of verifying that there are no significant differences at baseline to confirm that they are comparable after randomization Comparisons of means for independent samples will be carried out using the Students t-test for continuous variables and the Chi-square test for categorical variables The variables of the principal analysis will be the difference between the scores of the two groups REHACOPMCT and MCT in the scores of the scales assessing clinical and personalpsychological recovery The secondary results will be the differences in other assessments of social functioning cognitive biases and social cognition on comparing the two experimental conditions Changes in the scores of these scales will be analyzed using regression methods for repeated measures with the post-treatment score of the scales as the dependent variable and the basal score and the REHACOPMCT group as the co-variables Temporal stability of the results at 6 months will be assessed using the follow-up score as the dependent variable and evaluating how this affects the basal score post treatment and the experimental condition The statistical analyses will be performed according to intention to treat ITT without imputing the lost values Gender antipsychotic medication and disease evolution time will be considered as control variables
Limitations
One of the limitations of this clinical trial might be the loss to follow-up To compensate for these losses the sample size will be increased by 20 It is expected that the losses to follow-up will be similar in the two groups Otherwise this variable will be considered as an indicator of the acceptability of treatment
- Ethical considerations All the people who participate in the trial will sign the informed consent that takes into account the Declaration of Helsinki and the Organic Law 032018 of December 5 In the cases of minors informed consent will be signed by the legal guardians The project will be evaluated by each of the Ethics Committees of the participating centers
Participants will be informed that the data obtained will only be used for purposes related to the investigation and data confidentiality will be guaranteed according to the provisions of Organic Law 032018 of December 5 and Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 and data protection RGPD The data management plan generated by the project all information will be stored and managed in a secure and confidential manner in accordance with the provisions of Organic Law 032018 In order to scrupulously respect the current legislation the following measures will be taken
1 Personal data will be pseudonymized The identifying data are separated from the variables studied in the study Therefore a technical and functional separation will be made between the research team and those who perform the pseudonymization and retain the information that allows the reidentification of the participant Pseudonymized data will only be accessible to the research team when i there is an express commitment to confidentiality and no re-identification activity and ii specific security measures are taken to prevent re-identification and access to unauthorized personal
2 The person receiving the informed consent and custody will be different from the person who will process the data or if this is not possible the entire research team will sign an express commitment of confidentiality not to carry out re-identification activities The signed informed consents will be kept under lock and key and out of the reach of the research team in a generic sense
- General and specific objectives General objective Compare the efficacy of combined REHACOP MCT therapy vs MCT alone in persons with nonaffective psychotic disorder in terms of recovery
Specific objectives
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on clinical recovery clinical remission and functional recovery the latter understood in terms of cognitive occupational and social functioning
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on personalpsychological recovery
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone on cognitive biases and social cognition
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone according to gender
Evaluate the effects of combined REHACOP MCT therapy vs MCT alone according to self-esteem quality of life and stigma
Evaluate the maintenance of the effects of combined REHACOP MCT therapy vs MCT alone on clinical recovery personal recovery cognitive biases and social cognition in the long term
Methodology
Design
This will be a randomised clinical trial in which one group will receive combined REHACOP MCT therapy and another group will receive therapy with MCT alone The metacognitive treatment will have the same characteristics in the two treatment conditions Randomisation of the patients for receiving one of the two treatments will be carried out using a random number list based on the order of access to their reference centre The evaluator will be blinded to the treatment group to which the patient assessed belongs
Study subjects The sample will be made up of people with non-affective psychotic disorder who are attended in any of the centres participating in the study which belong to the following entitiesConsorci Sanitari de Terrassa Hospital de Mataró Instituto de Investigación Biomédica de Gerona IdIBG Parc Sanitari Sant Joan de Déu Asociación Centro de Higiene Mental Les Corts Hospital Sierrallana-Tres Mares and UGC Salud Mental de Jaén
Sample size Considering that the investigators have no preliminary data on our principal objective in relation to clinical and personal recovery the score obtained in the global assessment of functioning GAF at follow-up will be taken as a measure of outcome since it is implicated in both clinical and functional recovery The investigators used the data published in the article by Ochoa et al 2017 in order to calculate the required sample size for this study In this article a difference of means of 573 points SD1151 is obtained in the GAF scale from baseline and the follow-up at 6 months after the intervention With these data the necessary sample size has been estimated with an alpha of 005 and a power of 08 Taking into account 20 of possible losses to follow-up the sample size has been calculated as 160 cases 80 in each experimental arm REHACOP MCT vs MCT In this way taking into account that the intervention groups will be carried out in the health care centers of 7 different entities each will have to recruit 24 patients 12 for each experimental condition
Data collection the professional who makes the referral of the patients to the study will be responsible for reviewing fulfillment of the inclusion and exclusion criteria Patients fulfilling the inclusion criteria will receive an explanation of the study and if they accept to participate they must provide signed informed consent The evaluation will be carried out at 3 time points T0 basal assessment prior to initiation of treatment All the previously described scales will be administered T1 post-treatment evaluation all the scales will be administered and in addition the satisfaction perceived with the interventions received will be evaluated T2 follow-up evaluation at 6 months after completing the intervention all the scales will again be administered In addition the number of relapses and hospitalizations during the time interval will be registered Assessment of the PANSS and GAF should take into account the temporal criterium mentioned in the section of Outcomes A contingency plan will be considered in the event that difficulties are detected in carrying out any of the phases of the study due to external causes such as the continuity of the COVID-19 pandemic This plan will consist of the implementation of interventions and evaluations making use of new technologies All the centers already have the adequate infrastructure to carry out the project under these conditions
Data analysis Firstly the two groups will be compared with the aim of verifying that there are no significant differences at baseline to confirm that they are comparable after randomization Comparisons of means for independent samples will be carried out using the Students t-test for continuous variables and the Chi-square test for categorical variables The variables of the principal analysis will be the difference between the scores of the two groups REHACOPMCT and MCT in the scores of the scales assessing clinical and personalpsychological recovery The secondary results will be the differences in other assessments of social functioning cognitive biases and social cognition on comparing the two experimental conditions Changes in the scores of these scales will be analyzed using regression methods for repeated measures with the post-treatment score of the scales as the dependent variable and the basal score and the REHACOPMCT group as the co-variables Temporal stability of the results at 6 months will be assessed using the follow-up score as the dependent variable and evaluating how this affects the basal score post treatment and the experimental condition The statistical analyses will be performed according to intention to treat ITT without imputing the lost values Gender antipsychotic medication and disease evolution time will be considered as control variables
Limitations
One of the limitations of this clinical trial might be the loss to follow-up To compensate for these losses the sample size will be increased by 20 It is expected that the losses to follow-up will be similar in the two groups Otherwise this variable will be considered as an indicator of the acceptability of treatment
- Ethical considerations All the people who participate in the trial will sign the informed consent that takes into account the Declaration of Helsinki and the Organic Law 032018 of December 5 In the cases of minors informed consent will be signed by the legal guardians The project will be evaluated by each of the Ethics Committees of the participating centers
Participants will be informed that the data obtained will only be used for purposes related to the investigation and data confidentiality will be guaranteed according to the provisions of Organic Law 032018 of December 5 and Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 and data protection RGPD The data management plan generated by the project all information will be stored and managed in a secure and confidential manner in accordance with the provisions of Organic Law 032018 In order to scrupulously respect the current legislation the following measures will be taken
1 Personal data will be pseudonymized The identifying data are separated from the variables studied in the study Therefore a technical and functional separation will be made between the research team and those who perform the pseudonymization and retain the information that allows the reidentification of the participant Pseudonymized data will only be accessible to the research team when i there is an express commitment to confidentiality and no re-identification activity and ii specific security measures are taken to prevent re-identification and access to unauthorized personal
2 The person receiving the informed consent and custody will be different from the person who will process the data or if this is not possible the entire research team will sign an express commitment of confidentiality not to carry out re-identification activities The signed informed consents will be kept under lock and key and out of the reach of the research team in a generic sense
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None