Antenatal DepressionNCT04700501
Enjoy Your Bump - Implementation Study
A study testing Enjoy Your Bump - CBT life skills learning programme in people with Antenatal Depression, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Enjoy Your Bump is an implementation study relating to antenatal maternal mental health in women who have mild to moderate feelings of depression and anxiety. The investigators aim to address the following research question: Is a pregnancy-specific online CBT based life skills course (EYB) delivered antenatally… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Depression
- What is being tested?
- Enjoy Your Bump - CBT life skills learning programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2021to 8 Feb 2022
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16 or over,
- Capacity to give informed consent to participate in the study,
- Mild to moderate chronic Perinatal mental health (PMH) problems Score ≥3 on PHQ- 2,
- 8-32 week gestation
Who cannot join
- Severe Perinatal mental health problem - schizophrenia, bipolar disorder,
- Substance abuse/dependence,
- Active risk of self-harm,
- Insufficient English language to engage with intervention,
- No access to the internet
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh, Queens Medical Research Facility
Edinburgh, EH16 4TJ
About this study
Official title: On-line Cognitive Behavioural Therapy Intervention in Pregnancy 'Enjoy Your Bump': an Antenatal Intervention for Perinatal Anxiety
Enjoy Your Bump is an implementation study relating to antenatal maternal mental health in women who have mild to moderate feelings of depression and anxiety. The investigators aim to address the following research question: Is a pregnancy-specific online CBT based life skills course (EYB) delivered antenatally clinically effective in improving maternal anxiety symptom scores immediately post-intervention and at 12 weeks postpartum?
The investigators hypothesise that a pregnancy specific on-line CBT intervention delivered antenatally will improve PNMH during pregnancy and that this will be sustained at 3 months post-partum with beneficial effects for mother and child.
Read more
The pregnancy specific online CBT tool Enjoy Your Bump (EYB) course teaches CBT-based life skills to expecting mothers in a fun and low-jargon way. Participants are asked to complete 5 'core' modules and encouraged to take their time to learn, reflect and practice these new life skills.
The investigators anticipate recruiting approximately 100 women to participate in this implementation study. Mental health assessments will be conducted before starting the CBT programme, on completion of the programme and again at 6-12 weeks postnatal. The investigators anticipate an improvement in maternal mental health assessment scores in women who have completed the course and the investigators hope to observe a longer term effect in scores at 6-12 weeks postnatal.
Read the detailed description
One in four women have mental health problems, such as feeling anxious or depressed, during pregnancy and following childbirth. This not only impacts on the woman's own wellbeing but can also adversely affect the physical development and mental wellbeing of her child. The National Health Service (NHS) Long Term Plan aims to be able to provide better access to quality psychological interventions for women with mental health problems in pregnancy. Since the start of the Covid-19 outbreak in March 2020, pregnant women have been placed in a vulnerable group. There have been dramatic changes to maternity services in the community and hospital settings with remote midwife visits and changes to antenatal services. The normal support from friends and family has been reduced due to the current social distancing guidelines. This has all led to an increase in levels of stress and anxiety in the antenatal population.
The investigators have developed a unique pregnancy-specific on-line educational CBT based life skills course called Enjoy Your Bump (EYB). Unlike other CBT tools currently in use, this tool is specifically designed for use by pregnant women with chronic PNMH problems like elevated anxiety, mild depressive symptoms or high levels of self-reported stress. It also addresses specific concerns that women have during pregnancy, is the only pregnancy specific on-line CBT tool available and teaches CBT-based life skills in a fun and low-jargon way.
This implementation study will be open to any pregnant women in NHS Lothian who are experiencing mild or moderate symptoms of anxiety or depression. All pregnant women have access to an antenatal booking appointment with the community midwife following a positive pregnancy test. Women receive routine antenatal appointments during other stages of pregnancy and can participate in the study at any time point up to 32 weeks of pregnancy. During the booking appointment women are routinely asked two mental health questions:
- During the past month has the participant often been bothered by feeling down, depressed or hopeless?"
- During the past month has the participant often been bothered by having little interest or pleasure in doing things?"
If participants answer yes to either of these questions, the midwife can direct them to the online Enjoy Your Bump study website to gain further information about the study.
Information about this study will also be displayed in maternity waiting rooms in hospitals and on-line websites and women can self refer to participate.
Following completion of three baseline questionnaires, the participants will be provided with a link to the Enjoy Your Bump website. It can be completed using a tablet, smart phone, computer or kindle and is delivered as a modular intervention.
Women are asked to complete 5 'core' modules. There are additional optional modules and support materials the women can access to support their journey through the programme. The modules are supported by completion of 'worksheets' which can be accessed electronically. EYB is unique, as it is tailored to include specific issues relevant to pregnancy. At approximately 36 weeks gestation (after completion of the modules) the participants will be asked to complete 3 short questionnaires either by phone or by an email link to the study website. As part of routine practice all women receive a 6-12 week community follow up appointment by a health care professional. During this appointment the EPDS questionnaire is collected to assess postnatal mental Health.
- Conditions
- Antenatal Depression
- Being tested
- Enjoy Your Bump - CBT life skills learning programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enjoy Your Bump - CBT life skills learning programmeOther
Antenatal use of an online Cognitive Behavioural Therapy life skills learning programme to improve maternal feelings of anxiety and low mood.
| Study group | Role | What they receive |
|---|---|---|
| EYB Implementation study | Other | All participants will have the opportunity to access an online CBT life skills learning programme. Receives: Other: Enjoy Your Bump - CBT life skills learning programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure any change from baseline mental health scores when the General Anxiety Disorder-7 (GAD-7) is repeated on completion of the course, or at 36 weeks' gestation.
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: Through study completion, up to 1 year
To measure any change from baseline mental health scores when the Patient Health Questionnaire -8 (PHQ-8) is repeated on completion of the course, or at 36 weeks' gestation.
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. Eight patient questions, each of which is scored 0 to 3, providing a 0 to 24 severity score. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of - not at all, several days, more than half the days, and nearly every day, respectively. PHQ-8 total score for the eight items ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression, respectively.
Measured: Through study completion, up to 1 year
To measure any change from baseline mental health scores when the Edinburgh Postnatal Depression Score is repeated on completion of the course, or at 36 weeks' gestation.
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30).
Measured: Through study completion, up to 1 year
Secondary outcomes (2)
To measure the post-natal Edinburgh Postnatal Depression Scale (EPDS) scores when taken at 6-12 weeks by NHS Health Visitors.
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving maternal mental health scores at 6- 12 weeks following birth. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A higher score is indicative of poorer mental health.
Measured: Through study completion, up to 1 year
To measure the number of participants consented into the study.
To assess the uptake and completion of the CBT course.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start5 Jan 2021
- Primary completion30 Jun 2021
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Antenatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- implementation study
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Tommy's
- Responsible party
- Sponsor
- Investigators
- Professor R Reynolds, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700501
- Sponsor's protocol ID
- AC20128
- Other IDs
- 285587, 20/SS/0100
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antenatal and postnatal mental health: clinical management and service guidance. National Institute of Health and Clinical Excellence (NICE) guidelines [CG192] Published date: December 2014
Saving Lives, Improving Mothers' Care. Lessons learned to inform future maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2009-2012
Bauer A, Parsonage M, Knapp M, Lemmi V, Adelaja B. The costs of perinatal mental health problems. London School of Economics and Political Science. 2014.
Heron J, O'Connor TG, Evans J, Golding J, Glover V; ALSPAC Study Team. The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004 May;80(1):65-73. doi: 10.1016/j.jad.2003.08.004.
PubMed 15094259Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
PubMed 11485953Ashford MT, Olander EK, Ayers S. Computer- or web-based interventions for perinatal mental health: A systematic review. J Affect Disord. 2016 Jun;197:134-46. doi: 10.1016/j.jad.2016.02.057. Epub 2016 Mar 9.
PubMed 26991368Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy Childbirth. 2016 Feb 29;16:38. doi: 10.1186/s12884-016-0831-1.
PubMed 26928898
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-line Cognitive Behavioural Therapy Intervention in Pregnancy 'Enjoy Your Bump': an Antenatal Intervention for Perinatal Anxiety
- ClinicalTrials.gov ID
- NCT04700501
- Acronym / sponsor ID
- AC20128
- Conditions
- Antenatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Tommy's
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 8 Jan 2021 (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.
Enjoy Your Bump is an implementation study relating to antenatal maternal mental health in women who have mild to moderate feelings of depression and anxiety. The investigators aim to address the following research question: Is a pregnancy-specific online CBT based life skills course (EYB) delivered antenatally clinically effective in improving maternal anxiety symptom scores immediately post-intervention and at 12 weeks postpartum?
The investigators hypothesise that a pregnancy specific on-line CBT intervention delivered antenatally will improve PNMH during pregnancy and that this will be sustained at 3 months post-partum with beneficial effects for mother and child.
The pregnancy specific online CBT tool Enjoy Your Bump (EYB) course teaches CBT-based life skills to expecting mothers in a fun and low-jargon way. Participants are asked to complete 5 'core' modules and encouraged to take their time to learn, reflect and practice these new life skills.
The investigators anticipate recruiting approximately 100 women to participate in this implementation study. Mental health assessments will be conducted before starting the CBT programme, on completion of the programme and again at 6-12 weeks postnatal. The investigators anticipate an improvement in maternal mental health assessment scores in women who have completed the course and the investigators hope to observe a longer term effect in scores at 6-12 weeks postnatal.
Detailed description
One in four women have mental health problems, such as feeling anxious or depressed, during pregnancy and following childbirth. This not only impacts on the woman's own wellbeing but can also adversely affect the physical development and mental wellbeing of her child. The National Health Service (NHS) Long Term Plan aims to be able to provide better access to quality psychological interventions for women with mental health problems in pregnancy. Since the start of the Covid-19 outbreak in March 2020, pregnant women have been placed in a vulnerable group. There have been dramatic changes to maternity services in the community and hospital settings with remote midwife visits and changes to antenatal services. The normal support from friends and family has been reduced due to the current social distancing guidelines. This has all led to an increase in levels of stress and anxiety in the antenatal population.
The investigators have developed a unique pregnancy-specific on-line educational CBT based life skills course called Enjoy Your Bump (EYB). Unlike other CBT tools currently in use, this tool is specifically designed for use by pregnant women with chronic PNMH problems like elevated anxiety, mild depressive symptoms or high levels of self-reported stress. It also addresses specific concerns that women have during pregnancy, is the only pregnancy specific on-line CBT tool available and teaches CBT-based life skills in a fun and low-jargon way.
This implementation study will be open to any pregnant women in NHS Lothian who are experiencing mild or moderate symptoms of anxiety or depression. All pregnant women have access to an antenatal booking appointment with the community midwife following a positive pregnancy test. Women receive routine antenatal appointments during other stages of pregnancy and can participate in the study at any time point up to 32 weeks of pregnancy. During the booking appointment women are routinely asked two mental health questions:
- During the past month has the participant often been bothered by feeling down, depressed or hopeless?"
- During the past month has the participant often been bothered by having little interest or pleasure in doing things?"
If participants answer yes to either of these questions, the midwife can direct them to the online Enjoy Your Bump study website to gain further information about the study.
Information about this study will also be displayed in maternity waiting rooms in hospitals and on-line websites and women can self refer to participate.
Following completion of three baseline questionnaires, the participants will be provided with a link to the Enjoy Your Bump website. It can be completed using a tablet, smart phone, computer or kindle and is delivered as a modular intervention.
Women are asked to complete 5 'core' modules. There are additional optional modules and support materials the women can access to support their journey through the programme. The modules are supported by completion of 'worksheets' which can be accessed electronically. EYB is unique, as it is tailored to include specific issues relevant to pregnancy. At approximately 36 weeks gestation (after completion of the modules) the participants will be asked to complete 3 short questionnaires either by phone or by an email link to the study website. As part of routine practice all women receive a 6-12 week community follow up appointment by a health care professional. During this appointment the EPDS questionnaire is collected to assess postnatal mental Health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- implementation study
| Arm | Type | Receives |
|---|---|---|
| EYB Implementation study | Other | Other: Enjoy Your Bump - CBT life skills learning programmeAll participants will have the opportunity to access an online CBT life skills learning programme. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 16 or over,
- Capacity to give informed consent to participate in the study,
- Mild to moderate chronic Perinatal mental health (PMH) problems Score ≥3 on PHQ- 2,
- 8-32 week gestation
Key exclusion criteria (5 listed)
- Severe Perinatal mental health problem - schizophrenia, bipolar disorder,
- Substance abuse/dependence,
- Active risk of self-harm,
- Insufficient English language to engage with intervention,
- No access to the internet
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 |
|---|---|---|
| Enjoy Your Bump - CBT life skills learning programmeAntenatal use of an online Cognitive Behavioural Therapy life skills learning programme to improve maternal feelings of anxiety and low mood. | Other | EYB Implementation study |
Primary outcome
To measure any change from baseline mental health scores when the General Anxiety Disorder-7 (GAD-7) is repeated on completion of the course, or at 36 weeks' gestation.
Time frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
To measure any change from baseline mental health scores when the Patient Health Questionnaire -8 (PHQ-8) is repeated on completion of the course, or at 36 weeks' gestation.
Time frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. Eight patient questions, each of which is scored 0 to 3, providing a 0 to 24 severity score. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of - not at all, several days, more than half the days, and nearly every day, respectively. PHQ-8 total score for the eight items ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression, respectively.
To measure any change from baseline mental health scores when the Edinburgh Postnatal Depression Score is repeated on completion of the course, or at 36 weeks' gestation.
Time frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30).
2 secondary outcomes
To measure the post-natal Edinburgh Postnatal Depression Scale (EPDS) scores when taken at 6-12 weeks by NHS Health Visitors.
Time frame: Through study completion, up to 1 year
To measure the number of participants consented into the study.
Time frame: Through study completion, up to 1 year
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 Mar 2022.
- BackgroundAntenatal and postnatal mental health: clinical management and service guidance. National Institute of Health and Clinical Excellence (NICE) guidelines [CG192] Published date: December 2014
- BackgroundSaving Lives, Improving Mothers' Care. Lessons learned to inform future maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2009-2012
- BackgroundBauer A, Parsonage M, Knapp M, Lemmi V, Adelaja B. The costs of perinatal mental health problems. London School of Economics and Political Science. 2014.
- Background: PubMed 15094259Heron J, O'Connor TG, Evans J, Golding J, Glover V; ALSPAC Study Team. The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004 May;80(1):65-73. doi: 10.1016/j.jad.2003.08.004.
- Background: PubMed 11485953Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
- Background: PubMed 26991368Ashford MT, Olander EK, Ayers S. Computer- or web-based interventions for perinatal mental health: A systematic review. J Affect Disord. 2016 Jun;197:134-46. doi: 10.1016/j.jad.2016.02.057. Epub 2016 Mar 9.
- Background: PubMed 26928898Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy Childbirth. 2016 Feb 29;16:38. doi: 10.1186/s12884-016-0831-1.
- Chief Medical Office Annual Report 2014: women's healthLink provided by the sponsor.
- Perinatal mental health services needs assessment and recommendations.Link provided by the sponsor.
- Maternal mental health allianceLink provided by the sponsor.
- Five year forward view for mental health. one year onLink 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.
Professor R Reynolds principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enjoy Your Bump - CBT life skills learning programme in people with Antenatal Depression, run by University of Edinburgh 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 4 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 14 Mar 2022. 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 measure any change from baseline mental health scores when the General Anxiety Disorder-7 (GAD-7) is repeated on completion of the course, or at 36 weeks' gestation. (time frame: Through study completion, up to 1 year). The study lists 3 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 NCT04700501, which also lists 7 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 14 Mar 2022.