Prenatal StressPRENAYOGANCT05824208
PRENAYOGA: Exploratory Feasibility Study of Bi-weekly Pregnancy Yoga-based Sessions for Ethnic Minority Women
A study testing PRENAYOGA - prenatal yoga in people with Prenatal Stress and Pregnancy Related, run by King's College London at 1 site in United Kingdom.
Trial summary
Depression and anxiety are the most prevalent psychiatric disorders in the perinatal period. A recent report found that nearly 50% of new mothers in London (where 40% of the population is of ethnic minority background) display symptoms of postnatal depression (PND). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Stress, Pregnancy Related, Complementary
- What is being tested?
- PRENAYOGA - prenatal yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2023to 17 Jun 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age: week 20 of gestation or over, at the first session.
- Over 18 years of age.
- Basic understanding of English.
- Able to travel to the sessions.
- Belonging to an ethnic minority group (self-identified) other than White.
Who cannot join
- Physical or mental health diagnosis that would prevent them from attending yoga sessions, as per their healthcare professional's advice (self-reported).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT
London, SE5 9RT
About this study
Depression and anxiety are the most prevalent psychiatric disorders in the perinatal period. A recent report found that nearly 50% of new mothers in London (where 40% of the population is of ethnic minority background) display symptoms of postnatal depression (PND).
A 2022 report by the London School of Economics (LSE) found that treating maternal mental illness could save the National Health Service (NHS) £52 million over 10 years; in 2014, the LSE calculated that two-thirds of that cost is linked to adverse child development.
Read more
Prenatal depression results in adverse outcomes for the mother and infant, which are also linked to the impact of postnatal depression on the emotional relationship and attachment between the mother and the child. The major risk for developing depression postnatally is a history of depression, either in the lifetime or during pregnancy.
Several studies highlight that antenatal depression rates are higher in ethnic minority women. However, the percentage of ethnically diverse women in most studies on perinatal depression is negligible. Additionally, ethnic minority women are less represented in perinatal mental health therapeutic settings.
Preliminary evidence indicates prenatal yoga reduces anxiety and depression and improves mother-foetal attachment. Ethnic minorities support mind-body interventions such as yoga and may be more likely to engage in community-based activities than traditional antenatal classes.
An 8-week feasibility study will assess the feasibility and acceptability of a yoga-based intervention for ethnic minority women in London.
Read the detailed description
This exploratory feasibility study intends to understand participants' experiences and implementation considerations of an evidence-based, stakeholder-co-designed prenatal yoga intervention.
Participants will be recruited through signposting in the community and social media. Potential participants will complete an online form store on the study-specific SharePoint where they will include their name, date of birth, due date, mobile number, e-mail address, home address, GP/midwife contact details, frequency of previous yoga practice and availability for the study. This information will allow researchers to assess for eligibility and gather contact details for baseline assessment. The ICF and PIS will be sent to participants who fulfil the eligibility criteria. If participants do not enrol on the study, their information will be deleted.
Once they agree to be part of the study and basic demographics are collected on Zoom, participants will be sent, via e-mail, questionnaires to complete (on their phones or laptops) to evaluate their mental health, social support and attachment to the baby. These questionnaires are surveys that can be answered quickly and allow researchers to quantify changes in psychological states over time. Implementation questionnaires to understand how the intervention can be tested in future large-scale studies will also be collected on REDCap. Attendance and enrolment rates will also be collected for adherence and uptake implementation measures.
Questionnaires will be again completed at week 4 (midpoint of the study), week 8 (end of study), at 8 weeks postpartum and 6 months postpartum. There will be a 2-week leeway for questionnaire completion by participants.
Salivary cortisol samples will be collected at the beginning and end of sessions 1 and 8 to assess in-person changes in cortisol outputs during the yoga sessions.
Changes in participants' depression, anxiety, social support, maternal-foetal attachment and cortisol levels will be quantified to understand if the yoga programme may impact these aspects.
Participants will be asked to provide qualitative data on their views of the intervention and the study in the following formats:
- Focus group in the last week of the study on the experience of the intervention and barriers/facilitators
- Interviews with participants who attend less than 50% of sessions or withdraw from the study on their experience of the intervention and barriers/facilitators of the intervention.
Interviews and focus groups are optional (this is mentioned in the PIS and ICF).
Questions for focus groups and interviews will be around the overall experience of the intervention, expectations, acceptability, reasons for missed sessions, adoption, preference for sessions in person/online, willingness to undergo randomisation on an RCT, and acceptability of the questionnaires and samples. In the focus groups, I will also ask about facilitators and barriers, the appropriateness of the sessions, how feasible it was for them to attend the sessions and any factors that may affect the long-term scalability/sustainability of the yoga sessions.
Intervention: bi-weekly yoga classes (60 minutes duration, twice per week) will be delivered in person in a yoga studio in London for 8 consecutive weeks. Participants will be provided with yoga mats, blocks, bolsters and yoga straps at the studio. The class will be adapted to pregnancy and for all levels of ability, focusing on slow movements and body awareness. The content of the class will include loosening exercises (warm-up exercises), simple postures (standing, balancing, sitting, kneeling, supine and restorative poses), breathing exercises and meditation. Classes will be delivered by an internationally certified and trained yoga teacher and will be accompanied by soft instrumental music.
- Conditions
- Prenatal Stress, Pregnancy Related, Complementary
- Being tested
- PRENAYOGA - prenatal yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRENAYOGA - prenatal yogaBehavioural
The intervention is a prenatal yoga module developed for prenatal women. Intervention details: bi-weekly yoga classes (60 minutes of duration) will be delivered in person in a yoga studio in London for 8 consecutive weeks. Participants will be provided with yoga mats, blocks, bolsters and yoga straps at the studio. The class will be adapted to pregnancy and for all levels of ability, focusing on slow movements and body awareness. The content of the class will include loosening exercises (warm up exercises), simple postures (standing, balancing, sitting, kneeling, supine and restorative poses), breathing exercises and meditation. Classes will be delivered by an internationally certified and trained yoga teacher and will be accompanied by soft instrumental music.
| Study group | Role | What they receive |
|---|---|---|
| Bi-weekly pregnancy yoga-based sessions for 8 weeks | Experimental | Not described Receives: Behavioral: PRENAYOGA - prenatal yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the acceptability of the intervention
Total score of the Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) has a scale range of 1-5, with higher scores indicating greater acceptability.
Measured: End of intervention (week 8).
Secondary outcomes (19)
To assess reasons for perceived acceptability of the intervention
Focus groups
Measured: End of intervention (week 8).
To assess uptake/reach of the intervention
Number of eligible women that sign up to the intervention
Measured: End of intervention (week 8).
To assess the appropriateness of the intervention
Total score of the Intervention Appropriateness Measure (IAM). The Intervention Appropriateness Measure (IAM) has a scale range of 1-5, with higher scores indicating greater appropriateness of the intervention.
Measured: End of intervention (week 8).
To assess the feasibility of the intervention
Total score of the Feasibility of Intervention Measure (FIM). FIM has a scale range of 1-5, higher scores indicate greater feasibility of the intervention, assessing the practicality and potential for success of an intervention in a particular setting or population based on factors such as ease of implementation, cost-effectiveness, and stakeholder acceptability.
Measured: End of intervention (week 8).
To assess intervention adherence and attrition rates
Data on the overall adherence to the intervention, number of drops-outs each week.
Measured: End of intervention (week 8).
To assess the effects of quality of life
EQ5D-5L (quality of life measure). The EQ5D-5L is a quality of life measure that can be presented as EQ VAS and EQ-5D-5L index value.
Measured: Start (baseline) and end of intervention (week 8).
To assess factors affecting the sustainability and scalability of the intervention
Focus groups
Measured: End of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Exploratory investigation of the Maternal Foetal Attachment Scale. The Maternal Foetal Attachment Scale has 24 items. The items are scored on a five-point scale (1-5) with a total score ranging from 24 to 120, with higher scores indicating greater maternal-foetal attachment.
Measured: Start (baseline) and end of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Exploratory investigation of the Maternal Antenatal Attachment Scale. The Maternal Antenatal Attachment Scale has a scale range of 1-5 with a total score ranging from 19-95, with higher scores indicating greater maternal antenatal attachment.
Measured: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
The Edinburgh Postnatal Depression Scale (EPDS). The Edinburgh Postnatal Depression Scale (EPDS) has a range of 0-3, with a scale total range of 0-30, where higher scores indicate greater depressive symptoms.
Measured: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) has a scale range of 0-63, with higher scores indicating greater depressive symptoms. Each answer is scored on a scale value of 0-3.
Measured: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
State and Train Anxiety Inventory (STAI). The State and Trait Anxiety Inventory (STAI) is rated on a 4-point Likert scale and has a total scale range of 20-80, with higher scores indicating greater anxiety symptoms.
Measured: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Perceived Stress Scale (PSS). The PSS questionnaire typically contains 10 questions, and respondents rate their feelings and thoughts over the past month on a 5-point scale. The Perceived Stress Scale (PSS) has a scale range of 0-40, where higher scores indicate greater perceived stress.
Measured: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga affects mother-infant bond (postpartum)
Maternal Attachment Inventory (MAI). The Maternal Attachment Inventory (MAI) has a scale range of 22-88, with higher scores indicating greater maternal attachment.
Measured: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga improves social support and efficacy
Multidimensional Scale of Perceived Social Support (MSPSS). The Multidimensional Scale of Perceived Social Support (MSPSS) has a total scale range of 12-84 or subscale ranges of 3-7, with higher scores indicating greater perceived social support.
Measured: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga improves social support and efficacy
The Short General Self-Efficacy Scale (GSE-6). The Short General Self-Efficacy Scale (GSE-6) has a scale range of 6-30, with higher scores indicating greater general self-efficacy.
Measured: Start (baseline) and end of intervention (week 8).
To identify how the yoga sessions affect the lived experience of ethnic minority pregnant women
Focus groups
Measured: End of intervention (week 8).
To identify how the yoga sessions are perceived by the yoga teachers
Interviews
Measured: End of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Changes in scores of the Prenatal Attachment Inventory. The Prenatal Attachment Inventory has 21 items and is a scale ranging from 21-84, with higher scores indicating greater prenatal attachment.
items
Measured: Start (baseline) and end of intervention (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start28 Mar 2023
- Primary completion3 Jun 2023
- Study completion17 Jun 2023
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 Prenatal StressStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824208
- Sponsor's protocol ID
- HR/DP-22/23-34528
- Acronym
- PRENAYOGA
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Estevao C, Chiarpenello C, Kwok W, Bhargav H, Jasti N, Chandra P, Varambally S, Pariante C. Co-designing and evaluating a prenatal yoga intervention for ethnic minority women: a feasibility study. Pilot Feasibility Stud. 2025 Jul 7;11(1):96. doi: 10.1186/s40814-025-01667-9.
PubMed 40624724
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRENAYOGA: Exploratory Feasibility Study of Bi-weekly Pregnancy Yoga-based Sessions for Ethnic Minority Women
- ClinicalTrials.gov ID
- NCT05824208
- Acronym / sponsor ID
- PRENAYOGA / HR/DP-22/23-34528
- Conditions
- Prenatal Stress, Pregnancy Related, Complementary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 21 Apr 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.
Depression and anxiety are the most prevalent psychiatric disorders in the perinatal period. A recent report found that nearly 50% of new mothers in London (where 40% of the population is of ethnic minority background) display symptoms of postnatal depression (PND).
A 2022 report by the London School of Economics (LSE) found that treating maternal mental illness could save the National Health Service (NHS) £52 million over 10 years; in 2014, the LSE calculated that two-thirds of that cost is linked to adverse child development.
Prenatal depression results in adverse outcomes for the mother and infant, which are also linked to the impact of postnatal depression on the emotional relationship and attachment between the mother and the child. The major risk for developing depression postnatally is a history of depression, either in the lifetime or during pregnancy.
Several studies highlight that antenatal depression rates are higher in ethnic minority women. However, the percentage of ethnically diverse women in most studies on perinatal depression is negligible. Additionally, ethnic minority women are less represented in perinatal mental health therapeutic settings.
Preliminary evidence indicates prenatal yoga reduces anxiety and depression and improves mother-foetal attachment. Ethnic minorities support mind-body interventions such as yoga and may be more likely to engage in community-based activities than traditional antenatal classes.
An 8-week feasibility study will assess the feasibility and acceptability of a yoga-based intervention for ethnic minority women in London.
Detailed description
This exploratory feasibility study intends to understand participants' experiences and implementation considerations of an evidence-based, stakeholder-co-designed prenatal yoga intervention.
Participants will be recruited through signposting in the community and social media. Potential participants will complete an online form store on the study-specific SharePoint where they will include their name, date of birth, due date, mobile number, e-mail address, home address, GP/midwife contact details, frequency of previous yoga practice and availability for the study. This information will allow researchers to assess for eligibility and gather contact details for baseline assessment. The ICF and PIS will be sent to participants who fulfil the eligibility criteria. If participants do not enrol on the study, their information will be deleted.
Once they agree to be part of the study and basic demographics are collected on Zoom, participants will be sent, via e-mail, questionnaires to complete (on their phones or laptops) to evaluate their mental health, social support and attachment to the baby. These questionnaires are surveys that can be answered quickly and allow researchers to quantify changes in psychological states over time. Implementation questionnaires to understand how the intervention can be tested in future large-scale studies will also be collected on REDCap. Attendance and enrolment rates will also be collected for adherence and uptake implementation measures.
Questionnaires will be again completed at week 4 (midpoint of the study), week 8 (end of study), at 8 weeks postpartum and 6 months postpartum. There will be a 2-week leeway for questionnaire completion by participants.
Salivary cortisol samples will be collected at the beginning and end of sessions 1 and 8 to assess in-person changes in cortisol outputs during the yoga sessions.
Changes in participants' depression, anxiety, social support, maternal-foetal attachment and cortisol levels will be quantified to understand if the yoga programme may impact these aspects.
Participants will be asked to provide qualitative data on their views of the intervention and the study in the following formats:
- Focus group in the last week of the study on the experience of the intervention and barriers/facilitators
- Interviews with participants who attend less than 50% of sessions or withdraw from the study on their experience of the intervention and barriers/facilitators of the intervention.
Interviews and focus groups are optional (this is mentioned in the PIS and ICF).
Questions for focus groups and interviews will be around the overall experience of the intervention, expectations, acceptability, reasons for missed sessions, adoption, preference for sessions in person/online, willingness to undergo randomisation on an RCT, and acceptability of the questionnaires and samples. In the focus groups, I will also ask about facilitators and barriers, the appropriateness of the sessions, how feasible it was for them to attend the sessions and any factors that may affect the long-term scalability/sustainability of the yoga sessions.
Intervention: bi-weekly yoga classes (60 minutes duration, twice per week) will be delivered in person in a yoga studio in London for 8 consecutive weeks. Participants will be provided with yoga mats, blocks, bolsters and yoga straps at the studio. The class will be adapted to pregnancy and for all levels of ability, focusing on slow movements and body awareness. The content of the class will include loosening exercises (warm-up exercises), simple postures (standing, balancing, sitting, kneeling, supine and restorative poses), breathing exercises and meditation. Classes will be delivered by an internationally certified and trained yoga teacher and will be accompanied by soft instrumental music.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bi-weekly pregnancy yoga-based sessions for 8 weeks | Experimental | Behavioral: PRENAYOGA - prenatal yoga |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age: week 20 of gestation or over, at the first session.
- Over 18 years of age.
- Basic understanding of English.
- Able to travel to the sessions.
- Belonging to an ethnic minority group (self-identified) other than White.
Key exclusion criteria (1 listed)
- Physical or mental health diagnosis that would prevent them from attending yoga sessions, as per their healthcare professional's advice (self-reported).
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 |
|---|---|---|
| PRENAYOGA - prenatal yogaThe intervention is a prenatal yoga module developed for prenatal women. Intervention details: bi-weekly yoga classes (60 minutes of duration) will be delivered in person in a yoga studio in London for 8 consecutive weeks. Participants will be provided with yoga mats, blocks, bolsters and yoga straps at the studio. The class will be adapted to pregnancy and for all levels of ability, focusing on slow movements and body awareness. The content of the class will include loosening exercises (warm up exercises), simple postures (standing, balancing, sitting, kneeling, supine and restorative poses), breathing exercises and meditation. Classes will be delivered by an internationally certified and trained yoga teacher and will be accompanied by soft instrumental music. | Behavioural | Bi-weekly pregnancy yoga-based sessions for 8 weeks |
Primary outcome
To assess the acceptability of the intervention
Time frame: End of intervention (week 8).
Total score of the Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) has a scale range of 1-5, with higher scores indicating greater acceptability.
19 secondary outcomes
To assess reasons for perceived acceptability of the intervention
Time frame: End of intervention (week 8).
To assess uptake/reach of the intervention
Time frame: End of intervention (week 8).
To assess the appropriateness of the intervention
Time frame: End of intervention (week 8).
To assess the feasibility of the intervention
Time frame: End of intervention (week 8).
To assess intervention adherence and attrition rates
Time frame: End of intervention (week 8).
To assess the effects of quality of life
Time frame: Start (baseline) and end of intervention (week 8).
To assess factors affecting the sustainability and scalability of the intervention
Time frame: End of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Time frame: Start (baseline) and end of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Time frame: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Time frame: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Time frame: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Time frame: Start (baseline) and end of intervention (week 8).
To assess whether yoga improves further aspects of mental health
Time frame: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga affects mother-infant bond (postpartum)
Time frame: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga improves social support and efficacy
Time frame: Start (baseline) and end of intervention (week 8).
To ascertain whether yoga improves social support and efficacy
Time frame: Start (baseline) and end of intervention (week 8).
To identify how the yoga sessions affect the lived experience of ethnic minority pregnant women
Time frame: End of intervention (week 8).
To identify how the yoga sessions are perceived by the yoga teachers
Time frame: End of intervention (week 8).
To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment
Time frame: Start (baseline) and end of intervention (week 8).
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 14 Sep 2023.
- Derived from this study: PubMed 40624724Estevao C, Chiarpenello C, Kwok W, Bhargav H, Jasti N, Chandra P, Varambally S, Pariante C. Co-designing and evaluating a prenatal yoga intervention for ethnic minority women: a feasibility study. Pilot Feasibility Stud. 2025 Jul 7;11(1):96. doi: 10.1186/s40814-025-01667-9.
- Individual participant dataSharing planned: Undecided
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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 PRENAYOGA - prenatal yoga in people with Prenatal Stress and Pregnancy Related, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 1 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 14 Sep 2023. 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 Kingdom. 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?
To assess the acceptability of the intervention (time frame: End of intervention (week 8).). 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 NCT05824208, 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 14 Sep 2023.