Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:24 PM
Study NCT ID:
NCT07492056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Function Messures of a Psychological Flexibility Skills Training Based on ACT Over Disordered Eating Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disordered Eating Behaviors.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'A scale called "Dutch Eating Behaviour Questionnarie", that is validated on mexican population to mesure Disordered Eating Behaviors on three dimennsions, 1) Restrictive Eating. 2) Emotional Eating. 3) External Eating. Reactives: 33. Estimated application time: 20 minutes. No parametric data on mexican population, however, raw data will be taken from pre- and post-messures.'}, {'measure': 'Disordered Eating Behaviors.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'A scale called "Binge Eating Scale". Scores range from 0 min-46 max, normal score ranges from ≤17. Reactives: 16. Estimated application time: 6 to 8 minutes.'}, {'measure': 'Disordered Eating Behaviors.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'A scale called "Three-Factor Eating Questionnaire-R18 (TFEQ-R18)", that is validated on mexican population to mesure Disordered Eating Behaviors on three dimennsions, 1) Cognitive Restraint. 2) Emotional Eating. 3) Uncontrolled Eating. Scores range from min-18 to max-72, normal score ranges from 2.1 to 2.9. Reactives: 18. Estimated application time: 6 to 8 minutes.Estimated application time: 6 to 8 minutes.'}, {'measure': 'Anxiety Symtoms.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks', 'description': 'Anxiety Beck inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤12.'}, {'measure': 'Depression Symtoms.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'Beck Depression inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤10.'}, {'measure': 'Inhibitory Control', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'Stroop test, will be measured from the standardized executive function test BANFE, using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).'}, {'measure': 'Cognitive Flexibility', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'Card Sorting Test, will be measured from the standardized executive function test BANFE, using accurcy of response, perseverations, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).'}, {'measure': 'Social Cognition', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'Index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.'}, {'measure': 'Perceived Stress', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks.', 'description': 'Perceived Stress Scale (PSS), for mexican population. Scores range from min-3 to max-46, normal score ranges from 2.1 to 2.9. Estimated application time: 2 to 4 minutes.'}, {'measure': 'Body image satisfaction', 'timeFrame': 'Time Frame: Pre-post intervention assessment, after 12 weeks.', 'description': 'Body Shape Questionnaire (BSQ). Scores range from 18 min-108max, normal score ranges from ≤80. Estimated application time: 5 to 7 minutes.'}, {'measure': 'Neuroelectrical activity.', 'timeFrame': 'Pre-post intervention assessment, after 12 weeks', 'description': 'Global Brain Activity (GBA) electroencephalography neurophysiological recording of each participant will be performed, using food pictures taken from selected from the International Affective Picture System (IAPS) in an artifact-free room using a 14-channel Emotiv EPOC. Only 8 channels are going to be monitorized: Fp1, Fp2, F3, F4, F7, F8, P3 \\& P4, and only frequencies between 8-12, and 13 to 30, for Alpha and Beta, respectively. On Alpha frecuencies we are looking for Alpha suppression, desynchronization, when viewing food cues, interpreted as increased attentional engagement, while on Beta Higher power in frontal areas, linked to reward sensitivity, cognitive control, or arousal. The datasets will be stored in the research mainframe for subsequent property extraction and offline analysis using artificial intelligence tools and techniques.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Population (no Specific Condition or Disease)']}, 'descriptionModule': {'briefSummary': 'Overweight and obesity are an increasing tendencies worldwide. Disordered Eating Behaviors (DEBs) are feeding dynamics commonly present on them, as in Feeding Disorders (FD). These eating and body conditions are highly correlated with specific psychopathological symtoms, such as anxiety and depression, weight-related shame and stigma, and academic stress. Additionally, electroencephalographic findings suggest that weight- and eating-related conditions may be mediated by neural pathways specific to executive functions, such as selective attention and inhibitory control. Therefore, this cuasi-experimental design, pre- and post- measurement, longitudinal cross-sectional study aims to evaluate the effect of a training on psychological flexibility skills, based on Acceptance and Commitment Therapy (ACT) processes, on psychological, electroencephalographic and body composition measures.', 'detailedDescription': "This study is a Randomized Controlled Trial (RCT), according to the guidelines for CONSORT randomized controlled trials, (Hopewell, et al., 2025). Participants will be randomized and double-blinded. Stage 1: Clinical Trials Registration. Involvement Participant eligibility assessments (n = 30). Permanence analysis of participants and inclusion and exclusion criteria. Randomized groups (n = 30 ). Blinded 1: Group assignment; A = Wait List, control group, B = Psychological Flexibility Training Intervention Group. Randomization of participants to the intervention Blind Group 1: BGroup 2. Homologous rate of group assignment will be maintained. Psychometric, neuropsychological and neurophysiological measures will be used. The following assessment instruments will be used:\n\nNeuroimage: Global Brain Activity (GBA) electroencephalography neurophysiological recording of each participant will be performed, using food pictures taken from selected from the International Affective Picture System (IAPS) in an artifact-free room using a 14-channel Emotiv EPOC. Only 8 channels are going to be monitorized: Fp1, Fp2, F3, F4, F7, F8, P3 \\& P4, and only frequencies between 8-12, and 13 to 30, for Alpha and Beta, respectively. The datasets will be stored in the research mainframe for subsequent property extraction and offline analysis using artificial intelligence tools and techniques.\n\nExectutive Function: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd Edition (BANFE-3) (Flores-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 participant's 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. 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 he/she 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 his/her classification criterion according to the feedback provided by the evaluator is explored, especially in the conditions of criterion change.\n\nEating Bevarior: Binge Eating Scale (BES), validated in mexican population by Valdez-Aguilar (2022), has been selected to messure binge eating, composed of 16 items, and two factors, 1) Cognitive Manifestations and 2) Behavioral Manifestiations. In regards to restrictive eating, emotional eating and external eating, we've selected the Dutch Eating Behaviour Questionnarie, validated in mexican population by Grajeda, (2014). Additionally, to messure Cognitive Restrain, Emotional Eating and Uncontrolled Eating the Three-Factor Eating Questionnaire-R18 (TFEQ-R18), valitaded in mexican population by Wrzecionkowska and Rivera, (2021), has been selected.\n\nBeck 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 30 years old.\n* Currently enrrolled in university studies.\n* Attend at least 80% of the intervention sessions.\n\nExclusion Criteria:\n\n* Having a diagnosis of personality disorder.\n* Failure to attend post-assessment.\n* Currently attending psychological therapy or psychiatric care..'}, 'identificationModule': {'nctId': 'NCT07492056', 'acronym': 'FLEXEAT', 'briefTitle': 'Brain Function Messures of a Psychological Flexibility Skills Training Based on ACT Over Disordered Eating Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Baja California'}, 'officialTitle': 'Electroencephalographic and Body Composition and Psychometric Mesures of a Training of Psychological Flexibility Skills Based on ACT on ACT Processes on University Students of Mexicali and Mexicali Valley.', 'orgStudyIdInfo': {'id': 'MP/2026/IJACC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct intervention over outcomes.', 'interventionNames': ['Behavioral: A Psychological Flexibility Skills Training based on ACT.']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list', 'description': 'No intervention.'}], 'interventions': [{'name': 'A Psychological Flexibility Skills Training based on ACT.', 'type': 'BEHAVIORAL', 'description': 'Based on ACT procesess; defusion, presence, acceptance, perspective taking, values and commited action.', 'armGroupLabels': ['Direct intervention over outcomes.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Baja California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full time researcher', 'investigatorFullName': 'Gilberto Galindo', 'investigatorAffiliation': 'Universidad Autonoma de Baja California'}}}}