Specific Learning DisabilityMindUPNCT05787483
Biopsychosocial Outcomes of Mindfulness-based Instruction
A study testing MindUP group in people with Specific Learning Disability and Mental Health Issue, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Learning Disability, Mental Health Issue
- What is being tested?
- MindUP group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 16 Oct 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fifth grade students at i3 Academy
- fifth and sixth grade students at Tarrant Intermediate School
- 6th through 8th grade students at Spring Valley School
- All students enrolled in general education will be invited to participate in the study
Who cannot join
- those with medical, developmental, or psychiatric conditions that compromise their ability to provide valid self-reports or complete other study procedures
- only one child per family will be allowed to participate to avoid dependency in data due to clustering within families
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence
Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.
- Conditions
- Specific Learning Disability, Mental Health Issue
- Being tested
- MindUP group, active control group
- Keywords
- mindfulness-based-intervention, social and emotional learning, anxiety, stress, affect, executive function, academic achievement
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindUP groupBehavioural
MindUP is a Collaborative for Academic, Social, and Emotional Learning SELect (CASEL) program, meaning the program is evidence-based and meets the adequate criteria for developing students' social and emotional competence at the highest level. MindUP addresses all five components of the CASEL SEL Framework: self-awareness, social awareness, self-management, responsible decision-making, and relationship skills (CASEL, 2020). Students are taught how the workings of the brain are related to emotions, behaviors, decision making, and learning. MindUP is the first program to provide clear instruction in both SEL and mindfulness.
active control groupBehavioural
business as usual; regular wellness or SEL classes
| Study group | Role | What they receive |
|---|---|---|
| MindUP group | Experimental | Teachers in the MindUP group will deliver the program lessons twice a week for 30 minutes (1 hour per week) for 12 weeks. Based on previous studies, 12 weeks should be sufficient to cover the content from the 17 lessons. Receives: Behavioral: MindUP group |
| active control group | Active comparator | business as usual; regular wellness or SEL classes Receives: Behavioral: active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety - change
Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).
Measured: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up
Mindful attention - change
Mindful Attention Awareness Scale-Children (MAAS-C): has 15 items and measures the frequency of mindful states over time. Students are asked to rate how frequently they experience certain state in a 6-point Likert scale ranging from almost never to almost always (e.g., "I could be feeling a certain way and not realize it until later"; "I break or spill things because of carelessness, not paying attention, or thinking of something else").
Measured: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Secondary outcomes (5)
Positive and negative affect - change
The investigators will assess children's positive and negative affect weekly (12 times) using the Positive and Negative Affect Scale - child version. This will allow us to observe if there is change in student's affect due to the intervention. This is a 30-item scale in which the student is asked to rate in a 5-item scale ("not much or not al all" to "a lot") how much they felt certain positive and negative feelings and emotions during the past weeks (e.g., happy, sad, excited, ashamed, energetic, calm).
Measured: 12 times - once per week
Stress self-report - change
Self-report measure of perceived stress (Perceived Stress Scale - Child, PSS-C): has 13 items and is a measure of perceived stress developed for children aged 5 to 18 years. Students are asked questions about their feelings and thoughts during the previous week (e.g., "In the last week, how often did you feel rushed or hurried?"). Items are rated on a four-point scale from "0" (Never) to "3" (Very Often).
Measured: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Cortisol - change
Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of cortisol. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)
Measured: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Dehydroepiandrosterone (DHEA) - change
Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of DHEA. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)
Measured: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
C-reactive protein (CRP) - change
Stress and inflammation biomarkers in the students' saliva: Hypothalamic-pituitary-adrenocortical (HPA) regulation and inflammation will be assessed by measuring the presence of CRP. A sample of 1ml of saliva will be collected at each time point, three times within one day (9 A.M., 11:30 A.M., 2:30 P.M.)
Measured: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start14 Aug 2023
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Specific Learning DisabilityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline G. Richter, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787483
- Sponsor's protocol ID
- IRB-300010662
- Other IDs
- UAB
- Acronym
- MindUP
- Status last verified
- Oct 2025
- First submitted
- 1 Mar 2023
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belliveau C, Nagy C, Escobar S, Mechawar N, Turecki G, Rej S, Torres-Platas SG. Effects of Mindfulness-Based Cognitive Therapy on Peripheral Markers of Stress and Inflammation in Older-Adults With Depression and Anxiety: A Parallel Analysis of a Randomized Controlled Trial. Front Psychiatry. 2021 Dec 24;12:804269. doi: 10.3389/fpsyt.2021.804269. eCollection 2021.
PubMed 35002817Cummings JR, Ponce NA, Mays VM. Comparing racial/ethnic differences in mental health service use among high-need subpopulations across clinical and school-based settings. J Adolesc Health. 2010 Jun;46(6):603-6. doi: 10.1016/j.jadohealth.2009.11.221. Epub 2010 Feb 4.
PubMed 20472219Dunning DL, Griffiths K, Kuyken W, Crane C, Foulkes L, Parker J, Dalgleish T. Research Review: The effects of mindfulness-based interventions on cognition and mental health in children and adolescents - a meta-analysis of randomized controlled trials. J Child Psychol Psychiatry. 2019 Mar;60(3):244-258. doi: 10.1111/jcpp.12980. Epub 2018 Oct 22.
PubMed 30345511Schonert-Reichl KA, Oberle E, Lawlor MS, Abbott D, Thomson K, Oberlander TF, Diamond A. Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. Dev Psychol. 2015 Jan;51(1):52-66. doi: 10.1037/a0038454.
PubMed 25546595Morganti A, Ambrosi B, Sala C, Cianci L, Bochicchio D, Turolo L, Zanchetti A. Effects of angiotensin II blockade on the responses of the pituitary-adrenal axis to corticotropin-releasing factor in humans. J Cardiovasc Pharmacol. 1987;10 Suppl 7:S167-9. doi: 10.1097/00005344-198706107-00038.
PubMed 2485058Wren, D. G., & Benson, J. (2004). Measuring test anxiety in children: Scale development and internal construct validation. Anxiety, Stress & Coping, 17(3), 227-240. https://doi.org/10.1080/10615800412331292606
Lawlor, M. S., Schonert-Reichl, K. A., Gadermann, A. M., & Zumbo, B. D. (2014). A validation study of the mindful attention awareness scale adapted for children. Mindfulness, 5(6), 730-741. https://doi.org/10.1007/s12671-013-0228-4
Laurent, J., Catanzaro, S. J., Joiner Jr., T. E., Rudolph, K. D., Potter, K. I., Lambert, S., Osborne, L., & Gathright, T. (1999). A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment, 11(3), 326-338. https://doi.org/10.1037/1040-3590.11.3.326
White, B. P., & White, B. P. (2014). The perceived stress scale for children: A pilot study in a sample of 153 children. International Journal of Pediatrics and Child Health, 2(2), 45-52. https://doi.org/10.12974/2311-8687.2014.02.02.4
Gioia, G. A., Isquith, P. K., Guy, S. C., & Kenworthy, L. (2015). BRIEF-2: Behavior rating inventory of executive function: Professional manual. Psychological Assessment Resources.
Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
PubMed 23479546Rueda MR, Fan J, McCandliss BD, Halparin JD, Gruber DB, Lercari LP, Posner MI. Development of attentional networks in childhood. Neuropsychologia. 2004;42(8):1029-40. doi: 10.1016/j.neuropsychologia.2003.12.012.
PubMed 15093142Zelazo PD. The Dimensional Change Card Sort (DCCS): a method of assessing executive function in children. Nat Protoc. 2006;1(1):297-301. doi: 10.1038/nprot.2006.46.
PubMed 17406248Schrank, F. A., Mather, N., & McGrew, K. S. (2014). Woodcock-Johnson IV tests of achievement. Rolling Meadows, IL: Riverside.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence
- ClinicalTrials.gov ID
- NCT05787483
- Acronym / sponsor ID
- MindUP / IRB-300010662
- Conditions
- Specific Learning Disability, Mental Health Issue
- Keywords
- mindfulness-based-intervention, social and emotional learning, anxiety, stress, affect, executive function, academic achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 28 Mar 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.
Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindUP group | Experimental | Behavioral: MindUP groupTeachers in the MindUP group will deliver the program lessons twice a week for 30 minutes (1 hour per week) for 12 weeks. Based on previous studies, 12 weeks should be sufficient to cover the content from the 17 lessons. |
| active control group | Active comparator | Behavioral: active control groupbusiness as usual; regular wellness or SEL classes |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Fifth grade students at i3 Academy
- fifth and sixth grade students at Tarrant Intermediate School
- 6th through 8th grade students at Spring Valley School
- All students enrolled in general education will be invited to participate in the study
Key exclusion criteria (2 listed)
- those with medical, developmental, or psychiatric conditions that compromise their ability to provide valid self-reports or complete other study procedures
- only one child per family will be allowed to participate to avoid dependency in data due to clustering within families
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 |
|---|---|---|
| MindUP groupMindUP is a Collaborative for Academic, Social, and Emotional Learning SELect (CASEL) program, meaning the program is evidence-based and meets the adequate criteria for developing students' social and emotional competence at the highest level. MindUP addresses all five components of the CASEL SEL Framework: self-awareness, social awareness, self-management, responsible decision-making, and relationship skills (CASEL, 2020). Students are taught how the workings of the brain are related to emotions, behaviors, decision making, and learning. MindUP is the first program to provide clear instruction in both SEL and mindfulness. | Behavioural | MindUP group |
| active control groupbusiness as usual; regular wellness or SEL classes | Behavioural | active control group |
Primary outcome
Anxiety - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up
Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).
Mindful attention - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Mindful Attention Awareness Scale-Children (MAAS-C): has 15 items and measures the frequency of mindful states over time. Students are asked to rate how frequently they experience certain state in a 6-point Likert scale ranging from almost never to almost always (e.g., "I could be feeling a certain way and not realize it until later"; "I break or spill things because of carelessness, not paying attention, or thinking of something else").
5 secondary outcomes
Positive and negative affect - change
Time frame: 12 times - once per week
Stress self-report - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Cortisol - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
Dehydroepiandrosterone (DHEA) - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
C-reactive protein (CRP) - change
Time frame: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up
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 16 Oct 2025.
- Background: PubMed 35002817Belliveau C, Nagy C, Escobar S, Mechawar N, Turecki G, Rej S, Torres-Platas SG. Effects of Mindfulness-Based Cognitive Therapy on Peripheral Markers of Stress and Inflammation in Older-Adults With Depression and Anxiety: A Parallel Analysis of a Randomized Controlled Trial. Front Psychiatry. 2021 Dec 24;12:804269. doi: 10.3389/fpsyt.2021.804269. eCollection 2021.
- Background: PubMed 20472219Cummings JR, Ponce NA, Mays VM. Comparing racial/ethnic differences in mental health service use among high-need subpopulations across clinical and school-based settings. J Adolesc Health. 2010 Jun;46(6):603-6. doi: 10.1016/j.jadohealth.2009.11.221. Epub 2010 Feb 4.
- Background: PubMed 30345511Dunning DL, Griffiths K, Kuyken W, Crane C, Foulkes L, Parker J, Dalgleish T. Research Review: The effects of mindfulness-based interventions on cognition and mental health in children and adolescents - a meta-analysis of randomized controlled trials. J Child Psychol Psychiatry. 2019 Mar;60(3):244-258. doi: 10.1111/jcpp.12980. Epub 2018 Oct 22.
- Background: PubMed 25546595Schonert-Reichl KA, Oberle E, Lawlor MS, Abbott D, Thomson K, Oberlander TF, Diamond A. Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. Dev Psychol. 2015 Jan;51(1):52-66. doi: 10.1037/a0038454.
- Background: PubMed 2485058Morganti A, Ambrosi B, Sala C, Cianci L, Bochicchio D, Turolo L, Zanchetti A. Effects of angiotensin II blockade on the responses of the pituitary-adrenal axis to corticotropin-releasing factor in humans. J Cardiovasc Pharmacol. 1987;10 Suppl 7:S167-9. doi: 10.1097/00005344-198706107-00038.
- BackgroundWren, D. G., & Benson, J. (2004). Measuring test anxiety in children: Scale development and internal construct validation. Anxiety, Stress & Coping, 17(3), 227-240. https://doi.org/10.1080/10615800412331292606
- BackgroundLawlor, M. S., Schonert-Reichl, K. A., Gadermann, A. M., & Zumbo, B. D. (2014). A validation study of the mindful attention awareness scale adapted for children. Mindfulness, 5(6), 730-741. https://doi.org/10.1007/s12671-013-0228-4
- BackgroundLaurent, J., Catanzaro, S. J., Joiner Jr., T. E., Rudolph, K. D., Potter, K. I., Lambert, S., Osborne, L., & Gathright, T. (1999). A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment, 11(3), 326-338. https://doi.org/10.1037/1040-3590.11.3.326
- BackgroundWhite, B. P., & White, B. P. (2014). The perceived stress scale for children: A pilot study in a sample of 153 children. International Journal of Pediatrics and Child Health, 2(2), 45-52. https://doi.org/10.12974/2311-8687.2014.02.02.4
- BackgroundGioia, G. A., Isquith, P. K., Guy, S. C., & Kenworthy, L. (2015). BRIEF-2: Behavior rating inventory of executive function: Professional manual. Psychological Assessment Resources.
- Background: PubMed 23479546Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
- Background: PubMed 15093142Rueda MR, Fan J, McCandliss BD, Halparin JD, Gruber DB, Lercari LP, Posner MI. Development of attentional networks in childhood. Neuropsychologia. 2004;42(8):1029-40. doi: 10.1016/j.neuropsychologia.2003.12.012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindUP group in people with Specific Learning Disability and Mental Health Issue, run by University of Alabama at Birmingham at 1 site in United States.
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 4 inclusion and 2 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 16 Oct 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 United States. 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?
Anxiety - change (time frame: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up). The study lists 2 primary outcomes in all. 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 NCT05787483, which also lists 14 linked publications.
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 16 Oct 2025.