AnxietyOMETANCT06087185
Obesity and Mindful Eating in Patients With Anxiety
A study testing Mindful Eating and Video Group in people with Anxiety and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anxiety, Obesity, Eating Behavior
- What is being tested?
- Mindful Eating and Video Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 50 years old;
- Primary GAD diagnosed by the M.I.N.I.;
- ✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9)
Who cannot join
- In individuals with obesity or control only, not having any psychiatric disorder;
- In individuals with only GAD or control, do not have a BMI above 25.
- In individuals with GAD, not having a diagnosis of primary or severe depression;
- Being under psychopharmacological, psychotherapeutic or nutritional treatment;
- Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I);
- Have a clinical instability or immobility;
Show all 9Show fewer
- Being in Pregnancy or Lactation;
- Antisocial Personality Disorder;
- Eating Disorder.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.
Read the detailed description
This study is the second phase of a cross-sectional study.
- Conditions
- Anxiety, Obesity, Eating Behavior, Mindfulness, Inflammation, Self-Control
- Being tested
- Mindful Eating, Video Group
- Keywords
- Anxiety, Obesity, Eating Behavior, Mindfulness
- Medical subject headings
- Anxiety Disorders, Obesity, Feeding Behavior, Inflammation, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful EatingBehavioural
Also called Mindfulness, Eat for Life protocol
Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice.
Video GroupBehavioural
Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes.
Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Eating Group | Experimental | Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice. Receives: Behavioral: Mindful Eating |
| Video Group | Active comparator | Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes.
Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder. Receives: Behavioral: Video Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inhibitory Control
To evaluate the effectiveness of the Mindful Eating (ME) intervention in the performance in Go/No-go task compared to the control group with exposure to videos. This paradigm consists of the presentation of neutral images and food images on a computer screen (presented randomly, with a millisecond interval between them) and the participant must press or not press a key according to the researcher's instructions. The participant will be instructed to press the specific "Go" key when certain neutral images are viewed (office objects and bathroom objects). When food images and another class of neutral images (sports objects) are viewed, the participant will be instructed not to press any key and just wait (No Go). The "Go/No Go" paradigm, which has high reliability and replicability, makes it possible to evaluate inhibitory control, considering the commissioned number of errors in the No Go outcome.
Measured: 5 weeks
Secondary outcomes (15)
Change in Inflammatory Markers
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Protein C-reactive and Interleukine-6 compared to the control group with exposure to videos.
Measured: 5 weeks
Change in Emotional Regulation
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Difficulties in Emotion Regulation Scale (DERS) compared to the control group with exposure to videos. It is an instrument that assesses levels of emotional dysregulation in six domains. Contains 36 items on a 5-point Likert scale from 1 to 5.
Measured: 5 weeks
Change in Self-Compassion
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Self-Compassion Scale (SCS) compared to the control group with exposure to videos. The self-compassion scale was designed to measure self-compassion in three components: self-judgment versus self-kindness (SJ-SK), sense of isolation versus common humanity (I-CH), over-identification versus mindfulness (OI-M). Respondents must rate how they usually behave in difficult times, according to a scale with 26 5-point items. Therefore, the higher the total SCS score, the more self-compassionate the individual.
Measured: 5 weeks
Change in Impulsivity
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Barratt Impulsiveness Scale (BIS-11) compared to the control group with exposure to videos. The self-report scale developed by Barratt to assess these dimensions of impulsivity is composed of 20 questions for Inhibitory Control and 8 for Lack of Planning. The higher the score, the greater the level of impulsiveness.
Measured: 5 weeks
Change in Emotional Eating
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Factor Eating Questionnaire (TFEQ-R21) compared to the control group with exposure to videos. This questionnaire is a self-administered instrument that assesses cognitive restriction behaviors (six questions), emotional eating (six questions) and uncontrolled eating (nine questions) and has good internal consistency. It has a total of 21 questions in which individuals rate the statement as true or false on a four-point scale, with "1" being completely true and "4" being completely false.
Measured: 5 weeks
Change in Binge Eating
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Binge Eating Scale (BES) compared to the control group with exposure to videos. The BES is a self-administered Likert questionnaire, consisting of a list of 16 items and 62 statements, from which the one that best represents the individual's response must be selected for each item. Each statement corresponds to a number of points from 0 to 3, ranging from absence ("0") to maximum severity ("3") of binge eating.
Measured: 5 weeks
Change in Body Appreciation
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Appreciation Scale (BAS) compared to the control group with exposure to videos. The BAS is a 13-item questionnaire designed to assess the degree of body appreciation. Items are rated on a five-point scale ranging from one (never) to five (always). Higher scores reflect greater body appreciation.
Measured: 5 weeks
Change in Parental Bonding
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Parental Bonding Instrument (PBI) compared to the control group with exposure to videos.It is used to measure parental behavior as perceived by the offspring. The instrument consists of 25 items: 12 'care' items and 13 'protection' items. Raters are asked to rate the parents' behavior as they remember it in the first 16 years of their lives. For mothers, the cut-off point between the high and low scores is 27.0 and for the protection score it is 13.5. For parents, a care score of 24.0 and a protection score of 12.5.
Measured: 5 weeks
Change in Early Memories
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Early Memories of Warmth and Safeness Scale (EMWSS) compared to the control group with exposure to videos. The EMWSS is a measure that assesses emotional memories of being protected, loved and cared for by adults. The scale assesses recall of positive feelings particularly of safety, warmth and care during childhood. It is a 21-item Likert-type scale (from 0=never to 4=Yes, most of the time).
Measured: 5 weeks
Change in Early Life Experiences
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Early Life Experiences Scale (ELES) compared to the control group with exposure to videos. This scale was designed to measure recall of perceived threat and subordination in childhood. The scale, therefore, is composed of 15 items focused on recalling the perceived threat (six items) and feeling subordinate and acting submissively (nine items). The response measure consists of a Likert-type scale assessing how often and how true each statement was for them in their childhood.
Measured: 5 weeks
Change in Experiences in Close Relationships
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) compared to the control group with exposure to videos. The ECR-RS evaluates the bonding styles established in relationships with close people: father, mother, partner and friend. Each relationship is rated on a scale that theoretically comprises two factors: anxious and avoidant attachment. The total score for each subscale is the average of the items and ranges from 1 to 7, with higher scores indicating greater avoidant or anxious attachment.
Measured: 5 weeks
Change in Weight Bias Internalization
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Weight Bias Internalization Scale (WBIS) compared to the control group with exposure to videos. The scale score ranges from 11 to 77 points, with items 1 and 9 evaluated with reverse scoring. The WBIS is self-administered and has no cutoff point, however, higher scores indicate greater internalization of weight stigma.
Measured: 5 weeks
Change in BMI
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Mass Index (BMI) compared to the control group with exposure to videos.
Measured: 5 weeks
Change in Body Fat - Bioimpedance index
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of body fat percentage compared to the control group with exposure to videos.
Measured: 5 weeks
Change in Insulin resistance
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of HOMA index compared to the control group with exposure to videos. The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function and insulin sensitivity, as percentages of a normal reference population.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start23 Mar 2023
- Primary completion16 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Model description
- This is a Randomized Clinical Trial (RCT) comparing the effectiveness of the adapted Mindful Eating protocol to the control with exposure to videos promoting quality of life in adults with anxiety and obesity.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Gisele G Manfro, PhD, Study director, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087185
- Sponsor's protocol ID
- 66476322.5.0000.5327
- Other IDs
- 2022-0551
- Acronym
- OMETA
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim de Oliveira da Fonseca N, Rocha Dos Santos G, Foppa GT, Nunes da Luz Morelo G, Santos AZ, Weydmann G, Boaventura B, Flint SW, Antunes LC, Brietzke E, Manfro GG. Mindfulness-based eating in obesity and anxiety: a randomized controlled trial and feasibility assessment. Lancet Reg Health Am. 2026 Jul 15;59:101541. doi: 10.1016/j.lana.2026.101541. eCollection 2026 Jul.
PubMed 42482693
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
- ClinicalTrials.gov ID
- NCT06087185
- Acronym / sponsor ID
- OMETA / 66476322.5.0000.5327
- Conditions
- Anxiety, Obesity, Eating Behavior, Mindfulness, Inflammation, Self-Control
- Keywords
- Anxiety, Obesity, Eating Behavior, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 17 Oct 2023 (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.
Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.
Detailed description
This study is the second phase of a cross-sectional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Randomized Clinical Trial (RCT) comparing the effectiveness of the adapted Mindful Eating protocol to the control with exposure to videos promoting quality of life in adults with anxiety and obesity.
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating Group | Experimental | Behavioral: Mindful EatingMindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice. |
| Video Group | Active comparator | Behavioral: Video GroupComposed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between 18 and 50 years old;
- Primary GAD diagnosed by the M.I.N.I.;
- ✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9)
Key exclusion criteria (9 listed)
- In individuals with obesity or control only, not having any psychiatric disorder;
- In individuals with only GAD or control, do not have a BMI above 25.
- In individuals with GAD, not having a diagnosis of primary or severe depression;
- Being under psychopharmacological, psychotherapeutic or nutritional treatment;
- Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I);
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 |
|---|---|---|
| Mindful EatingAlso: Mindfulness, Eat for Life protocolMindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice. | Behavioural | Mindful Eating Group |
| Video GroupComposed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder. | Behavioural | Video Group |
Primary outcome
Change in Inhibitory Control
Time frame: 5 weeks
To evaluate the effectiveness of the Mindful Eating (ME) intervention in the performance in Go/No-go task compared to the control group with exposure to videos. This paradigm consists of the presentation of neutral images and food images on a computer screen (presented randomly, with a millisecond interval between them) and the participant must press or not press a key according to the researcher's instructions. The participant will be instructed to press the specific "Go" key when certain neutral images are viewed (office objects and bathroom objects). When food images and another class of neutral images (sports objects) are viewed, the participant will be instructed not to press any key and just wait (No Go). The "Go/No Go" paradigm, which has high reliability and replicability, makes it possible to evaluate inhibitory control, considering the commissioned number of errors in the No Go outcome.
15 secondary outcomes
Change in Inflammatory Markers
Time frame: 5 weeks
Change in Emotional Regulation
Time frame: 5 weeks
Change in Self-Compassion
Time frame: 5 weeks
Change in Impulsivity
Time frame: 5 weeks
Change in Emotional Eating
Time frame: 5 weeks
Change in Binge Eating
Time frame: 5 weeks
Change in Body Appreciation
Time frame: 5 weeks
Change in Parental Bonding
Time frame: 5 weeks
Change in Early Memories
Time frame: 5 weeks
Change in Early Life Experiences
Time frame: 5 weeks
Change in Experiences in Close Relationships
Time frame: 5 weeks
Change in Weight Bias Internalization
Time frame: 5 weeks
Change in BMI
Time frame: 5 weeks
Change in Body Fat - Bioimpedance index
Time frame: 5 weeks
Change in Insulin resistance
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 42482693Kim de Oliveira da Fonseca N, Rocha Dos Santos G, Foppa GT, Nunes da Luz Morelo G, Santos AZ, Weydmann G, Boaventura B, Flint SW, Antunes LC, Brietzke E, Manfro GG. Mindfulness-based eating in obesity and anxiety: a randomized controlled trial and feasibility assessment. Lancet Reg Health Am. 2026 Jul 15;59:101541. doi: 10.1016/j.lana.2026.101541. eCollection 2026 Jul.
- OMETA InstagramLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gisele G Manfro, PhD study director
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating and Video Group in people with Anxiety and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 9 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: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Inhibitory Control (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087185, which also lists 1 linked publication.
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 15 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.