General Population (no Specific Condition or Disease)FLEXEATNCT07492056
Brain Function Messures of a Psychological Flexibility Skills Training Based on ACT Over Disordered Eating Behaviors
A study testing A Psychological Flexibility Skills Training based on ACT. in people with General Population (no Specific Condition or Disease), run by Universidad Autonoma de Baja California.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population (no Specific Condition or Disease)
- What is being tested?
- A Psychological Flexibility Skills Training based on ACT.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 30 years old.
- Currently enrrolled in university studies.
- Attend at least 80% of the intervention sessions.
Who cannot join
- Having a diagnosis of personality disorder.
- Failure to attend post-assessment.
- Currently attending psychological therapy or psychiatric care..
About this study
Official title: 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.
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.
Read the detailed description
This study is a Randomized Controlled Trial (RCT), according to the guidelines for CONSORT randomized controlled trials. 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:
Neuroimage: 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.
Executive Function: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd Edition (BANFE-3). 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 hability 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.
Eating Bevarior: Binge Eating Scale (BES), validated in mexican population, 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. Additionally, to messure Cognitive Restrain, Emotional Eating and Uncontrolled Eating the Three-Factor Eating Questionnaire-R18 (TFEQ-R18), valitaded in mexican population, has been selected.
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.
- Being tested
- A Psychological Flexibility Skills Training based on ACT.
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Psychological Flexibility Skills Training based on ACT.Behavioural
Based on ACT procesess; defusion, presence, acceptance, perspective taking, values and commited action.
| Study group | Role | What they receive |
|---|---|---|
| Direct intervention over outcomes. | Experimental | Not described Receives: Behavioral: A Psychological Flexibility Skills Training based on ACT. |
| Wait list | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disordered Eating Behaviors.
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.
Measured: Pre-post intervention assessment, after 12 weeks.
Disordered Eating Behaviors.
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.
Measured: Pre-post intervention assessment, after 12 weeks.
Disordered Eating Behaviors.
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.
Measured: Pre-post intervention assessment, after 12 weeks.
Anxiety Symtoms.
Anxiety Beck inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤12.
Measured: Pre-post intervention assessment, after 12 weeks
Depression Symtoms.
Beck Depression inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤10.
Measured: Pre-post intervention assessment, after 12 weeks.
Inhibitory Control
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).
Measured: Pre-post intervention assessment, after 12 weeks.
Cognitive Flexibility
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).
Measured: Pre-post intervention assessment, after 12 weeks.
Social Cognition
Index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.
Measured: Pre-post intervention assessment, after 12 weeks.
Perceived Stress
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.
Measured: Pre-post intervention assessment, after 12 weeks.
Body image satisfaction
Body Shape Questionnaire (BSQ). Scores range from 18 min-108max, normal score ranges from ≤80. Estimated application time: 5 to 7 minutes.
Measured: Time Frame: Pre-post intervention assessment, after 12 weeks.
Neuroelectrical activity.
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.
Measured: Pre-post intervention assessment, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Population (no Specific Condition or Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Galindo, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492056
- Sponsor's protocol ID
- MP/2026/IJACC
- Acronym
- FLEXEAT
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07492056
- Acronym / sponsor ID
- FLEXEAT / MP/2026/IJACC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Randomized Controlled Trial (RCT), according to the guidelines for CONSORT randomized controlled trials. 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:
Neuroimage: 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.
Executive Function: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd Edition (BANFE-3). 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 hability 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.
Eating Bevarior: Binge Eating Scale (BES), validated in mexican population, 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. Additionally, to messure Cognitive Restrain, Emotional Eating and Uncontrolled Eating the Three-Factor Eating Questionnaire-R18 (TFEQ-R18), valitaded in mexican population, has been selected.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct intervention over outcomes. | Experimental | Behavioral: A Psychological Flexibility Skills Training based on ACT. |
| Wait list | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18 and 30 years old.
- Currently enrrolled in university studies.
- Attend at least 80% of the intervention sessions.
Key exclusion criteria (3 listed)
- Having a diagnosis of personality disorder.
- Failure to attend post-assessment.
- Currently attending psychological therapy or psychiatric care..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Psychological Flexibility Skills Training based on ACT.Based on ACT procesess; defusion, presence, acceptance, perspective taking, values and commited action. | Behavioural | Direct intervention over outcomes. |
Primary outcome
Disordered Eating Behaviors.
Time frame: Pre-post intervention assessment, after 12 weeks.
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.
Disordered Eating Behaviors.
Time frame: Pre-post intervention assessment, after 12 weeks.
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.
Disordered Eating Behaviors.
Time frame: Pre-post intervention assessment, after 12 weeks.
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.
Anxiety Symtoms.
Time frame: Pre-post intervention assessment, after 12 weeks
Anxiety Beck inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤12.
Depression Symtoms.
Time frame: Pre-post intervention assessment, after 12 weeks.
Beck Depression inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤10.
Inhibitory Control
Time frame: Pre-post intervention assessment, after 12 weeks.
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).
Cognitive Flexibility
Time frame: Pre-post intervention assessment, after 12 weeks.
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).
Social Cognition
Time frame: Pre-post intervention assessment, after 12 weeks.
Index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.
Perceived Stress
Time frame: Pre-post intervention assessment, after 12 weeks.
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.
Body image satisfaction
Time frame: Time Frame: Pre-post intervention assessment, after 12 weeks.
Body Shape Questionnaire (BSQ). Scores range from 18 min-108max, normal score ranges from ≤80. Estimated application time: 5 to 7 minutes.
Neuroelectrical activity.
Time frame: Pre-post intervention assessment, after 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A Psychological Flexibility Skills Training based on ACT. in people with General Population (no Specific Condition or Disease), run by Universidad Autonoma de Baja California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disordered Eating Behaviors. (time frame: Pre-post intervention assessment, after 12 weeks.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.