Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618339
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Clinical Trials to Evaluate Neurophysiological and Neuropsychological Effects of a Mindfulness-based Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trials to Measure Neurophysiological Effects Using EEG Signals Artificial Intelligence and Neuropsychological Techniques of a Mindfulness-Based Intervention in Young Adults with Symptoms of Anxiety and Depression
Status:
ENROLLING_BY_INVITATION
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:
PRESENTE-IA
Brief Summary:
Depression and anxiety are conditions with a high prevalence in the world population and youth are no exception In developing countries it is reported that given the conditions of social disadvantage anxiety and depression are higher resulting in compromised psychological well-being and mental health Therefore treatments that help in the care and prevention of these disorders from youth are important In the case of contemporary psychology Mindfulness treatments have emerged as an alternative treatment for some of the symptoms of depression anxiety and emotional discomfort showing evidence of increased improvement in the overall quality of life The project responds to global mental health demands and will provide the institution as well as external collaborating institutions and society in general with guidelines to carry out brief and effective interventions for these problems and will develop clinical evidence and technological tools for their analysis Objective To compare the neurophysiological effects by means of EEG signals and machine learning or deep learning techniques and neuropsychological effects of a brief treatment based on mindfulness-based intervention techniques as an alternative intervention for the reduction of anxiety and depression symptoms against the effects of psychoeducation groups and placebo group in young adults Methodology Factorial design of cases and controls according to the guidelines for randomized controlled trials CONSORT Participants n125 will be randomized triple-blinded with neuropsychological and neurophysiological assessments The results of the project will generate basic evidence on the condition of brain functioning at the neurophysiological level its performance to perform processes of utmost relevance to solve daily life problems and psychological well-being as well as support the development of techniques for specialists in behavioral analysis and mental health and engineering sciences for the creation and implementation of programs and strategies for the prevention identification care and evaluation of mental health and social well-being with a scientific and community health approach
Detailed Description:
Protocol
Study type Factorial case-control design according to the guidelines for CONSORT randomized controlled trials Cuschieri 2019 Participants will be randomized triple-blinded
Stage 1 Clinical Trials Registration Involvement Participant eligibility assessments n 125 Participant permanence analysis inclusion and exclusion criteria Randomized groups n 125 Blinded 1 Group assignment A placebo treatment control group B mindfulness-based intervention group C PE-based intervention group
Randomization of participants to the intervention Blind 2 Group 1 A Group 2 B Group 3 C A homologous rate of group assignment will be maintained Neuropsychological assessment measurements and neurophysiological measures Neuropsychological assessment
To measure changes in the functioning of the cognitive processes of interest Executive Functions Attention Memory and Social Cognition we propose to use the following assessment instruments
Neuropsychological Battery of Executive Functions and Frontal Lobes 3rd Edition BANFE-3Flores-Lázaro et al 2021 This is an instrument that allows exploring the functioning of 16 executive processes Metamemory figurative meaning comprehension abstract attitude verbal fluency productivity cognitive flexibility visuospatial planning sequential planning inverse sequencing encoding control self-directed working memory verbal working memory visuospatial sequential working memory inhibitory control rule following and risk-benefit processing
The exploration of these processes is performed through 14 tasks that were adapted from paradigms already tested in neuropsychological and neuroimaging studies in previous international studies According to the authors the test has sufficient convergent and clinical validity The reliability assessed through inter-rater agreement is 80 The parameters were obtained from its application in a sample of Mexican participants without atypical functioning conditions
The tests of interest for this study are described below
Stroop Effect It is considered an indicator of inhibitory control functioning since it evaluates the participant39s ability to stop an automatic response and execute a non-dominant one In this version a sheet is used in which columns of six words are presented with color names that presuppose two conditions in the neutral condition the person should only read the word that corresponds to the color of the ink with which it is printed on the sheet while in the conflict condition the participant must name the color of the ink with which the word is printed avoiding reading it in this condition there is no concordance between the word and the color of the ink so that a situation of cognitive conflict is generated
Card game Adapted from the Iowa card test developed by Antoine Bechara 2003 and which explores the participant39s ability to select a response under conditions of uncertainty and to detect risk-benefit relationships so it is considered a sensitive task to measure decision making The task is posed as a game in which the participant is presented with 10 decks of cards five in which each one contains cards numbered from one to five respectively and five that are placed in front of them and in which the cards are placed face down as they contain possible punishments that imply losing points The task of the person being evaluated is to earn as many points as possible by choosing one card at a time from the five decks with the visible numbers For each card selected the evaluator will turn over one card from the corresponding deck to find out if it contains any punishment
Tower of Hanoi It is considered a sensitive task to evaluate the ability to plan sequential actions to achieve a specific goal For its application a toy is used that consists of a wooden base with three bars placed vertically at the same distance and a set of disks of different sizes that can be inserted into the bars The activity consists of the participant moving the disks in order from smallest to largest size by placing them on the first bar towards the third bar following three main rules no more than one disk can be moved at a time larger disks cannot be placed on top of a smaller one and the participant can only move one disk at a time
placed on top of a smaller one and when removing them they must always be placed on one of the bars In this set there are two levels of difficulty according to the number of discs three and four
Alphabetical word order According to the original authors of this paradigm it evaluates the capacity to maintain information in working memory and manipulate it mentally The participant must listen to a list of words and repeat it according to the alphabetical order of the initial The list can be repeated in a maximum of five trials Three lists are presented that progressively increase in complexity by number of words and by use of consonants and vowels
Letter Sorting This task is based on the Wisconsin letter sorting test and has been associated with cognitive flexibility functioning Here the participant is asked to look at a base sheet containing the image of four cards that have geometric shapes that vary in shape color and number of shapes on each card The participant is given a deck of 64 cards with the same characteristics and is asked to place each one of them under the card that heshe believes corresponds to the card on the sheet based on its characteristics The evaluator can only answer yes or no according to a criterion established by the evaluator and that will change progressively but is not perceptible to the individual The ability of the participant to modify hisher classification criterion according to the feedback provided by the evaluator is explored especially in the conditions of criterion change
Metamemory This task evaluates the individual39s ability to predict his own performance in a task of learning a list of words The test consists of the subject trying to repeat a list of nine words in any order but trying to learn as many as possible over five trials Before each trial the participant must make a prediction of how many words heshe will be able to repeat taking into consideration hisher performance in the previous repetitions and the perception heshe has of hisher own memory
Behavioral assessment of executive function for adults BRIEF-A Roth Isquith amp Gioia 2005 this is a response inventory composed of 75 statements that are answered on a Likert scale with three options never sometimes and frequently It yields results grouped into nine clinical scales inhibition flexibility emotional control self-monitoring initiative working memory planningorganization task monitoring and organization of materials and three composite indices Emotional Regulation Index Metamemory Index and Global Composite of Executive Functioning It also offers three validity scales denial infrequency and inconsistency This test does not have norms for Mexican population but it has been widely used in the context of research in Mexico and Latin America because it allows evaluating executive functioning in an ecological way
NEUROPSI Attention and Memory 3 ed Ostrosky et al 2019 It is a neuropsychological assessment instrument that includes the assessment of three cognitive domains Attention Memory and Executive Functioning through tasks of different level of complexity and different sensory modalities It evaluates people between 6 and 85 years old and its norms are based on Mexican population According to the authors of the test it has an adequate sensitivity to detect clinical alterations so it is considered to have appropriate levels of discriminatory validity
For the present project we intend to implement tasks to determine changes in attention and memory processes The tasks are described below
Digit retention in progression this is a classic task to assess attention in the auditory modality It consists of the presentation of numerical sequences of increasing length that the participant must repeat in the same order in which they were presented
Digit detection This is a task to assess attention The participant must listen to a series of numbers numbers while they are read by the evaluator and when heshe hears the number 5 preceded by the number 2 heshe must tap the table
Memory curve This task consists of the participant having to listen to a list of 12 words during three consecutive repetitions after each of which heshe must try to retrieve as many words as possible regardless of the order in which they are repeated For the evocation phase after 30 minutes the patient will be asked to try to spontaneously retrieve as many words as possible
Gaze test This test was originally designed in 2001 by Baron-Cohen with the aim of assessing the ability of individuals to detect intentions through facial expressions focused on the gaze The computerized version developed by Galindo et al 2018 will be used which consists of 28 trials in which visual stimuli are presented showing the eyes of people making a particular expression that the participant must identify by selecting from four possible options This instrument will be used to assess social cognition functions
Neurophysiological recording Instruments and materials A resting-state electroencephalography neurophysiological recording of each participant will be performed in an artifact-free room using a 14-channel Emotiv EPOC The datasets will be stored in the research mainframe for subsequent property extraction and offline analysis using artificial intelligence tools and techniques
Stage 2 Intervention The interventions will be carried out through a 9-week group training that will be composed of 14 sessions of 60 minutes and will be administered twice a week by a professional psychologist with experience in the application of Mindfulness and CBT techniques according to the corresponding group ANNEX intervention programs
Follow-up Intervention Self-assessment record of intervention findings optional Beck Anxiety Inventory
For the measurement of depression the Beck Hopelessness Scale is used composed of 20 items and three factors validated in Mexican population by Quiñonez-Tapia et al 2019
For the measurement of anxiety the Beck anxiety scale composed of 21 items and four factors Subjective Neurophysiological Autonomic Vasomotor symptoms validated in Mexican population by Vázquez et al 2015 is used
Neuropsychological assessment measures and neurophysiological measures Stage 3 Blind 3 Statistical analysis The project statistician will perform the comparisons of the results of the groups in ignorance of the assignment of labels of each group as well as free of the assignment of the participants to the same and will return to the principal investigator the results outputs ANOVA will be applied for hypothesis testingTechnique and Sample size calculation
The sample considered for the study is 125 participantscalculated for the comparison of means of five groups with 22 participants each expecting an effect size of 04 probability of error type 005 a power 1-prob err of 095
Study type Factorial case-control design according to the guidelines for CONSORT randomized controlled trials Cuschieri 2019 Participants will be randomized triple-blinded
Stage 1 Clinical Trials Registration Involvement Participant eligibility assessments n 125 Participant permanence analysis inclusion and exclusion criteria Randomized groups n 125 Blinded 1 Group assignment A placebo treatment control group B mindfulness-based intervention group C PE-based intervention group
Randomization of participants to the intervention Blind 2 Group 1 A Group 2 B Group 3 C A homologous rate of group assignment will be maintained Neuropsychological assessment measurements and neurophysiological measures Neuropsychological assessment
To measure changes in the functioning of the cognitive processes of interest Executive Functions Attention Memory and Social Cognition we propose to use the following assessment instruments
Neuropsychological Battery of Executive Functions and Frontal Lobes 3rd Edition BANFE-3Flores-Lázaro et al 2021 This is an instrument that allows exploring the functioning of 16 executive processes Metamemory figurative meaning comprehension abstract attitude verbal fluency productivity cognitive flexibility visuospatial planning sequential planning inverse sequencing encoding control self-directed working memory verbal working memory visuospatial sequential working memory inhibitory control rule following and risk-benefit processing
The exploration of these processes is performed through 14 tasks that were adapted from paradigms already tested in neuropsychological and neuroimaging studies in previous international studies According to the authors the test has sufficient convergent and clinical validity The reliability assessed through inter-rater agreement is 80 The parameters were obtained from its application in a sample of Mexican participants without atypical functioning conditions
The tests of interest for this study are described below
Stroop Effect It is considered an indicator of inhibitory control functioning since it evaluates the participant39s ability to stop an automatic response and execute a non-dominant one In this version a sheet is used in which columns of six words are presented with color names that presuppose two conditions in the neutral condition the person should only read the word that corresponds to the color of the ink with which it is printed on the sheet while in the conflict condition the participant must name the color of the ink with which the word is printed avoiding reading it in this condition there is no concordance between the word and the color of the ink so that a situation of cognitive conflict is generated
Card game Adapted from the Iowa card test developed by Antoine Bechara 2003 and which explores the participant39s ability to select a response under conditions of uncertainty and to detect risk-benefit relationships so it is considered a sensitive task to measure decision making The task is posed as a game in which the participant is presented with 10 decks of cards five in which each one contains cards numbered from one to five respectively and five that are placed in front of them and in which the cards are placed face down as they contain possible punishments that imply losing points The task of the person being evaluated is to earn as many points as possible by choosing one card at a time from the five decks with the visible numbers For each card selected the evaluator will turn over one card from the corresponding deck to find out if it contains any punishment
Tower of Hanoi It is considered a sensitive task to evaluate the ability to plan sequential actions to achieve a specific goal For its application a toy is used that consists of a wooden base with three bars placed vertically at the same distance and a set of disks of different sizes that can be inserted into the bars The activity consists of the participant moving the disks in order from smallest to largest size by placing them on the first bar towards the third bar following three main rules no more than one disk can be moved at a time larger disks cannot be placed on top of a smaller one and the participant can only move one disk at a time
placed on top of a smaller one and when removing them they must always be placed on one of the bars In this set there are two levels of difficulty according to the number of discs three and four
Alphabetical word order According to the original authors of this paradigm it evaluates the capacity to maintain information in working memory and manipulate it mentally The participant must listen to a list of words and repeat it according to the alphabetical order of the initial The list can be repeated in a maximum of five trials Three lists are presented that progressively increase in complexity by number of words and by use of consonants and vowels
Letter Sorting This task is based on the Wisconsin letter sorting test and has been associated with cognitive flexibility functioning Here the participant is asked to look at a base sheet containing the image of four cards that have geometric shapes that vary in shape color and number of shapes on each card The participant is given a deck of 64 cards with the same characteristics and is asked to place each one of them under the card that heshe believes corresponds to the card on the sheet based on its characteristics The evaluator can only answer yes or no according to a criterion established by the evaluator and that will change progressively but is not perceptible to the individual The ability of the participant to modify hisher classification criterion according to the feedback provided by the evaluator is explored especially in the conditions of criterion change
Metamemory This task evaluates the individual39s ability to predict his own performance in a task of learning a list of words The test consists of the subject trying to repeat a list of nine words in any order but trying to learn as many as possible over five trials Before each trial the participant must make a prediction of how many words heshe will be able to repeat taking into consideration hisher performance in the previous repetitions and the perception heshe has of hisher own memory
Behavioral assessment of executive function for adults BRIEF-A Roth Isquith amp Gioia 2005 this is a response inventory composed of 75 statements that are answered on a Likert scale with three options never sometimes and frequently It yields results grouped into nine clinical scales inhibition flexibility emotional control self-monitoring initiative working memory planningorganization task monitoring and organization of materials and three composite indices Emotional Regulation Index Metamemory Index and Global Composite of Executive Functioning It also offers three validity scales denial infrequency and inconsistency This test does not have norms for Mexican population but it has been widely used in the context of research in Mexico and Latin America because it allows evaluating executive functioning in an ecological way
NEUROPSI Attention and Memory 3 ed Ostrosky et al 2019 It is a neuropsychological assessment instrument that includes the assessment of three cognitive domains Attention Memory and Executive Functioning through tasks of different level of complexity and different sensory modalities It evaluates people between 6 and 85 years old and its norms are based on Mexican population According to the authors of the test it has an adequate sensitivity to detect clinical alterations so it is considered to have appropriate levels of discriminatory validity
For the present project we intend to implement tasks to determine changes in attention and memory processes The tasks are described below
Digit retention in progression this is a classic task to assess attention in the auditory modality It consists of the presentation of numerical sequences of increasing length that the participant must repeat in the same order in which they were presented
Digit detection This is a task to assess attention The participant must listen to a series of numbers numbers while they are read by the evaluator and when heshe hears the number 5 preceded by the number 2 heshe must tap the table
Memory curve This task consists of the participant having to listen to a list of 12 words during three consecutive repetitions after each of which heshe must try to retrieve as many words as possible regardless of the order in which they are repeated For the evocation phase after 30 minutes the patient will be asked to try to spontaneously retrieve as many words as possible
Gaze test This test was originally designed in 2001 by Baron-Cohen with the aim of assessing the ability of individuals to detect intentions through facial expressions focused on the gaze The computerized version developed by Galindo et al 2018 will be used which consists of 28 trials in which visual stimuli are presented showing the eyes of people making a particular expression that the participant must identify by selecting from four possible options This instrument will be used to assess social cognition functions
Neurophysiological recording Instruments and materials A resting-state electroencephalography neurophysiological recording of each participant will be performed in an artifact-free room using a 14-channel Emotiv EPOC The datasets will be stored in the research mainframe for subsequent property extraction and offline analysis using artificial intelligence tools and techniques
Stage 2 Intervention The interventions will be carried out through a 9-week group training that will be composed of 14 sessions of 60 minutes and will be administered twice a week by a professional psychologist with experience in the application of Mindfulness and CBT techniques according to the corresponding group ANNEX intervention programs
Follow-up Intervention Self-assessment record of intervention findings optional Beck Anxiety Inventory
For the measurement of depression the Beck Hopelessness Scale is used composed of 20 items and three factors validated in Mexican population by Quiñonez-Tapia et al 2019
For the measurement of anxiety the Beck anxiety scale composed of 21 items and four factors Subjective Neurophysiological Autonomic Vasomotor symptoms validated in Mexican population by Vázquez et al 2015 is used
Neuropsychological assessment measures and neurophysiological measures Stage 3 Blind 3 Statistical analysis The project statistician will perform the comparisons of the results of the groups in ignorance of the assignment of labels of each group as well as free of the assignment of the participants to the same and will return to the principal investigator the results outputs ANOVA will be applied for hypothesis testingTechnique and Sample size calculation
The sample considered for the study is 125 participantscalculated for the comparison of means of five groups with 22 participants each expecting an effect size of 04 probability of error type 005 a power 1-prob err of 095
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