Alzheimer Disease and Related DementiasMASCNCT05847153

MASC: Reducing Stress for Caregivers

A study testing MASC in people with Alzheimer Disease and Related Dementias and Dementia Alzheimers, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease and Related Dementias, Dementia Alzheimers
What is being tested?: MASC
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2023to 13 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years or older
English fluency and literacy
Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
Must live with and care for an individual with ADRD
Must have been in a caregiver role for more than 6 months
Must provide an average 4 hours of supervision or direct assistance per day for the are recipient
Perceived Stress Scale-4 (4-item) version >=6
Had managed 1 or more behavioral symptoms in past month

Who cannot join

Recent change ini psychotropic treatment for depression or anxiety
Use of mindfulness apps or any meditation (more than 60 min/week in past 6 months)
Involvement in another clinical trial for caregivers, a score >= 4 on the Portable Mental Status Questionnaire (PMSQ)
No stated concerns or distress related to care recipient's disruptive behaviors
Involvement in another clinical trial for caregivers

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02108

Other trials in United States

About this study

Official title: The Mindful and Self-Compassionate Care Program Aim 2

Building on limitations of prior research, the investigators proposed to develop the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.

Read the detailed description

Over half of Alzheimer Disease and Related Dementias (ADRD) caregivers are actively looking for non-pharmacological interventions to decrease caregiver stress. Available programs do not meet the psychological and practical needs of stressed caregivers of persons with ADRD; better solutions are needed. First, while helpful, most support groups do not systematically teach behavioral management skills which caregivers report needing in order to manage challenging patient behaviors. Second, behavioral management skills interventions exist, but do not teach: 1) emotional regulation skills which are necessary in order to foster caregiver ability to access and use these skills to manage patient behaviors, and/or 2) self-compassion and compassion skills which are necessary to bypass guilt and loneliness and navigate behavioral symptoms which are common caregiver challenges. Third, mindfulness and self-compassion interventions are effective solutions for managing stress, and distress across multiple populations, but engagement and efficacy among diverse ADRD caregivers are limited.

The guiding hypothesis of this proposal is that combining evidence-based mindfulness and self-compassion skills with behavioral management skills within a multi-component program increases intervention potency and efficiently supports caregivers of persons with ADRD. Accounting for practical challenges to engagement (nr. sessions, delivery modality, skill practice) will also enhance uptake and reach.

The investigators will conduct an open pilot with exit interviews to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and wellbeing (NIH stage 1A; N= up to 20 caregivers; N= up to 2 groups. Exit interviews will last 30 minutes and will be recorded, transcribed, and analyzed to refine study procedures. The investigators will use this information to revise and optimize MASC and our conceptual model, as needed to maximize feasibility and target engagement.

The investigators will recruit caregivers of persons with ADRD from local community organizations and caregiver support programs; dementia research programs; and from national programs that focus on caregiving.

Conditions: Alzheimer Disease and Related Dementias, Dementia Alzheimers
Being tested: MASC
Keywords: ADRD, Caregiver stress, Dementia, Alzheimer, Self-compassion
Medical subject headings: Alzheimer Disease, Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MASCBehavioural
The intervention arm will be comprised of:
1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.

Study groups in NCT05847153
Study group	Role	What they receive
Intervention	Experimental	The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life. Receives: Behavioral: MASC

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Recruitment
The investigators will examine feasibility of recruitment overall. The investigators will report proportion of eligible participants who are eligible and choose to enroll in the study. The investigators will also explore the percent of racial and ethnically diverse participants across the entire sample. Benchmark: ≥70% of participants who are eligible will enroll; ≥38% of participants are racial and ethnic minorities (US representation)
Measured: Baseline
Number of Participants With Less Than 25% of Missing Questionnaires at Baseline
The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.
Measured: Baseline
Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention
The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.
Measured: Post-intervention (6-8 weeks post baseline)
Number of Participants With no Questionnaries Missing Fully at Baseline
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.
Measured: Baseline
Number of Participants With no Questionnaries Missing Fully at Post-intervention
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.
Measured: Post-intervention (6-8 weeks post baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 202313 Jan 2024

First posted6 May 2023
Study start12 Sep 2023
Primary completion13 Jan 2024
Study completion13 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Alzheimer Disease and Related DementiasStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: MASC is an intervention that includes evidence based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC has 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05847153
Sponsor's protocol ID: 2023P001130
Other IDs: 1R01AG078204-01
Acronym: MASC
Status last verified: Jun 2025
First submitted: 7 Apr 2023
Last updated: 19 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz KM. Societal and Family Lifetime Cost of Dementia: Implications for Policy. J Am Geriatr Soc. 2017 Oct;65(10):2169-2175. doi: 10.1111/jgs.15043. Epub 2017 Aug 17.
PubMed 28815557
Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d.
PubMed 19282676
Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available.
PubMed 21502853
Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
PubMed 19585957
Jennings LA, Reuben DB, Evertson LC, Serrano KS, Ercoli L, Grill J, Chodosh J, Tan Z, Wenger NS. Unmet needs of caregivers of individuals referred to a dementia care program. J Am Geriatr Soc. 2015 Feb;63(2):282-9. doi: 10.1111/jgs.13251.
PubMed 25688604
Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.
PubMed 28501707
Pedro J, Monteiro-Reis S, Carvalho-Maia C, Henrique R, Jeronimo C, Silva ER. Evidence of psychological and biological effects of structured Mindfulness-Based Interventions for cancer patients and survivors: A meta-review. Psychooncology. 2021 Nov;30(11):1836-1848. doi: 10.1002/pon.5771. Epub 2021 Jul 28.
PubMed 34288218
Conversano C, Orru G, Pozza A, Miccoli M, Ciacchini R, Marchi L, Gemignani A. Is Mindfulness-Based Stress Reduction Effective for People with Hypertension? A Systematic Review and Meta-Analysis of 30 Years of Evidence. Int J Environ Res Public Health. 2021 Mar 11;18(6):2882. doi: 10.3390/ijerph18062882.
PubMed 33799828
Al-Refae M, Al-Refae A, Munroe M, Sardella NA, Ferrari M. A Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene) for Depression, Anxiety, and Stress: Promoting Adaptive Emotional Regulation and Wisdom. Front Psychol. 2021 Mar 22;12:648087. doi: 10.3389/fpsyg.2021.648087. eCollection 2021.
PubMed 33828514
Mahaffey BL, Mackin DM, Vranceanu AM, Lofaro L, Bromet EJ, Luft BJ, Gonzalez A. The Stony Brook Health Enhancement Program: The development of an active control condition for mind-body interventions. J Health Psychol. 2020 Nov-Dec;25(13-14):2129-2140. doi: 10.1177/1359105318787024. Epub 2018 Jul 16.
PubMed 30010422
Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1. doi: 10.1186/2055-5784-1-1. Epub 2015 Jan 12.
PubMed 29611687
Travis A, O'Donnell A, Giraldo-Santiago N, Stone SM, Torres D, Adler SR, Vranceanu AM, Ritchie CS. Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia. JMIR Res Protoc. 2024 Oct 11;13:e58356. doi: 10.2196/58356.
PubMed 39392675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Alzheimer Disease and Related Dementias trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Mindful and Self-Compassionate Care Program Aim 2
ClinicalTrials.gov ID: NCT05847153
Acronym / sponsor ID: MASC / 2023P001130
Conditions: Alzheimer Disease and Related Dementias, Dementia Alzheimers
Keywords: ADRD, Caregiver stress, Dementia, Alzheimer, Self-compassion
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Aging (NIA)
Study start: 12 Sep 2023 (actual)
Primary completion: 13 Jan 2024 (actual)
Study completion: 13 Jan 2024 (actual)
First posted: 6 May 2023 (actual)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: MASC is an intervention that includes evidence based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC has 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice.

Arm	Type	Receives
Intervention	Experimental	Behavioral: MASCThe intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

18 years or older
English fluency and literacy
Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
Must live with and care for an individual with ADRD
Must have been in a caregiver role for more than 6 months

Key exclusion criteria (5 listed)

Recent change ini psychotropic treatment for depression or anxiety
Use of mindfulness apps or any meditation (more than 60 min/week in past 6 months)
Involvement in another clinical trial for caregivers, a score >= 4 on the Portable Mental Status Questionnaire (PMSQ)
No stated concerns or distress related to care recipient's disruptive behaviors
Involvement in another clinical trial for caregivers

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
MASCThe intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.	Behavioural	Intervention

Primary outcome

Feasibility of Recruitment
Time frame: Baseline
The investigators will examine feasibility of recruitment overall. The investigators will report proportion of eligible participants who are eligible and choose to enroll in the study. The investigators will also explore the percent of racial and ethnically diverse participants across the entire sample. Benchmark: ≥70% of participants who are eligible will enroll; ≥38% of participants are racial and ethnic minorities (US representation)
Number of Participants With Less Than 25% of Missing Questionnaires at Baseline
Time frame: Baseline
The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.
Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention
Time frame: Post-intervention (6-8 weeks post baseline)
The investigators will calculate the proportion of participants completing the study who have less than 25% of missing questionnaires. Benchmark: ≥70% participants will have less than 25% missing questionnaires.
Number of Participants With no Questionnaries Missing Fully at Baseline
Time frame: Baseline
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.
Number of Participants With no Questionnaries Missing Fully at Post-intervention
Time frame: Post-intervention (6-8 weeks post baseline)
The investigators will assess the feasibility of the quantitative measures sent to participants. Benchmark: No questionnaires missing fully in ≥25% participants.

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	13	11

Primary outcome: Feasibility of Recruitment

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Intervention n = 16
Enrolled Participants	13
Racial and Ethnic Minorities	4

Population analysed: 16 participants were eligible and 13 chose to enroll. Out of the 13 that chose to enroll, 4 were racial and ethnic minorities.

Primary outcome: Number of Participants With Less Than 25% of Missing Questionnaires at Baseline

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Intervention n = 13
Value	13

Population analysed: The number of participants who completed the baseline questionnaire is 13.

Primary outcome: Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention

Time frame: Post-intervention (6-8 weeks post baseline). Count of participants. Unit: Participants

Measure	Intervention n = 12
Value	11

Population analysed: While 13 participants completed the baseline survey, only 12/13 participants attended the sessions (intervention). Therefore,12 participants were counted as completing the study, which was measured as those who completed the baseline survey and attended the intervention sessions. 11/12 completed participants completed the post-intervention survey.

Primary outcome: Number of Participants With no Questionnaries Missing Fully at Baseline

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Intervention n = 13
Value	13

Adverse events

Time frame: Adverse event data was collected for each participant by participant self-report over the course of baseline administration (upto 1 week before the intervention started), the six week intervention, and up to the post-intervention assessment, which was conducted up to 1-week after conclusion of the intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28815557Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz KM. Societal and Family Lifetime Cost of Dementia: Implications for Policy. J Am Geriatr Soc. 2017 Oct;65(10):2169-2175. doi: 10.1111/jgs.15043. Epub 2017 Aug 17.
Background: PubMed 19282676Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d.
Background: PubMed 21502853Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available.
Background: PubMed 19585957Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
Background: PubMed 25688604Jennings LA, Reuben DB, Evertson LC, Serrano KS, Ercoli L, Grill J, Chodosh J, Tan Z, Wenger NS. Unmet needs of caregivers of individuals referred to a dementia care program. J Am Geriatr Soc. 2015 Feb;63(2):282-9. doi: 10.1111/jgs.13251.
Background: PubMed 28501707Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.
Background: PubMed 34288218Pedro J, Monteiro-Reis S, Carvalho-Maia C, Henrique R, Jeronimo C, Silva ER. Evidence of psychological and biological effects of structured Mindfulness-Based Interventions for cancer patients and survivors: A meta-review. Psychooncology. 2021 Nov;30(11):1836-1848. doi: 10.1002/pon.5771. Epub 2021 Jul 28.
Background: PubMed 33799828Conversano C, Orru G, Pozza A, Miccoli M, Ciacchini R, Marchi L, Gemignani A. Is Mindfulness-Based Stress Reduction Effective for People with Hypertension? A Systematic Review and Meta-Analysis of 30 Years of Evidence. Int J Environ Res Public Health. 2021 Mar 11;18(6):2882. doi: 10.3390/ijerph18062882.
Background: PubMed 33828514Al-Refae M, Al-Refae A, Munroe M, Sardella NA, Ferrari M. A Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene) for Depression, Anxiety, and Stress: Promoting Adaptive Emotional Regulation and Wisdom. Front Psychol. 2021 Mar 22;12:648087. doi: 10.3389/fpsyg.2021.648087. eCollection 2021.
Background: PubMed 30010422Mahaffey BL, Mackin DM, Vranceanu AM, Lofaro L, Bromet EJ, Luft BJ, Gonzalez A. The Stony Brook Health Enhancement Program: The development of an active control condition for mind-body interventions. J Health Psychol. 2020 Nov-Dec;25(13-14):2129-2140. doi: 10.1177/1359105318787024. Epub 2018 Jul 16.
Background: PubMed 29611687Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1. doi: 10.1186/2055-5784-1-1. Epub 2015 Jan 12.
Derived from this study: PubMed 39392675Travis A, O'Donnell A, Giraldo-Santiago N, Stone SM, Torres D, Adler SR, Vranceanu AM, Ritchie CS. Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia. JMIR Res Protoc. 2024 Oct 11;13:e58356. doi: 10.2196/58356.
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.

Christine S Ritchie, MD, MSPH principal investigator

Massachusetts General Hospital

Ana-Maria Vranceanu, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MASC in people with Alzheimer Disease and Related Dementias and Dementia Alzheimers, run by Massachusetts General Hospital 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 8 inclusion and 5 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 19 Mar 2026. 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?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Recruitment (time frame: Baseline). The study lists 5 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 NCT05847153, which also lists 12 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 19 Mar 2026.