DepressionPM+NCT04617262
Pilot Feasibility Study of Remote Problem Management Plus for Adults Affected by COVID-19
A study testing Remote Problem Management Plus in people with Depression and Anxiety Disorders, run by The New School at 1 site in United States.
Trial summary
This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders, Psychological Distress
- What is being tested?
- Remote Problem Management Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 20 May 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Help- or treatment-seeking
- Access to a device for conducting sessions via Zoom (e.g., smartphone, tablet, laptop or personal computer)
Who cannot join
- Acute medical conditions or severe cognitive impairment (e.g., severe intellectual disability or dementia)
- Imminent suicide risk or expressed acute needs/protection risks (e.g., intimate partner violence risk)
- Presence of severe mental disorder (e.g., psychotic disorders)
- Hazardous substance use, substance dependency or substance use disorder (assessed using the Drug Abuse Screening Test (DAST-10) and Alcohol Use Disorders Identification Test (AUDIT-C)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Feasibility Study of Remote Problem Management Plus to Improve Well-being and Functioning of Adults Affected by COVID-
This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.
Read the detailed description
Problem Management Plus (PM+) is recommended as part of the World Health Organization Mental Health Gap Action Program for communities affected by adversity. It is a low-intensity, scalable manualized intervention that was designed according to a task-sharing model of care. PM+ has four core features that make the intervention suitable for populations exposed to adversities in low-resource settings. First, it is a brief intervention (five sessions); second, it can be delivered by paraprofessionals (trained, non-specialist workers, lay or peer providers under the supervision of a mental health professional), using the principle of task shifting/task sharing; third, it is designed as a trans-diagnostic intervention to address a range of client-identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; and, fourth, it is designed for communities affected by any kind of adversity (e.g. violence, disasters) in low-income countries. The intervention was originally developed for adults affected by humanitarian crises and tested in low-income countries. A number of randomized controlled trials in Kenya, Pakistan, Nepal, as well as the Netherlands have indicated that PM+ delivered by non-specialist helpers is effective in decreasing symptoms of psychological distress (including depression, anxiety and post-traumatic stress disorder symptoms) and improving functioning; however, empirical evidence of the feasibility and efficacy of the remote training and delivery of PM+ is limited.
In May 2020, the United Nations released a policy brief emphasizing inclusion of mental health and psychosocial support (MHPSS) in national response plans including scaling up access to remote support (UN, 2020). The brief was released in response to emerging concerns of the negative mental health and psychosocial impacts arising from the health and societal consequences of COVID-19. Extant population-based research is showing high rates of anxiety, depression, and general distress in the US, while at the same time MHPSS provision has been disrupted or halted due to social distancing measures. Remote delivery forms of PM+ may serve as an important mechanism to facilitate access to care during the ongoing pandemic and into the future. Furthermore, there is very limited research with PM+ in high-income countries where specialized mental health interventions are available, but where access for certain populations or during periods of public health crisis is limited due to systemic and practical barriers. Even in high income countries, only 22.4% of those with depression receive minimally adequate care; however, 64.9% of those with depression perceive a need for treatment. The treatment gap may be considerably higher among marginalized groups and economically disadvantaged communities. COVID-19 continues to bring on widespread mental health disparities, particularly among vulnerable and underserved communities that are disproportionately affected by COVID-19. Brief, low-intensity interventions designed to be implemented by non-specialists represent a promising and scalable approach to minimize this treatment gap in under-served US populations by partnering with community-based organizations (CBO) to train and supervise staff already involved in social and public health services. An important first step before investing resources in training and implementation with CBOs is to evaluate the feasibility, acceptability and effectiveness of remotely delivered PM+ with relevant community samples.
This is the first study to evaluate remotely delivered PM+ implemented by helpers whose training and supervision was conducted entirely online, as well as one of the first trials evaluating PM+ with community samples in the US. The aims of this pilot feasibility study are to a) assess interest from perspective beneficiaries by partnering with community-based organizations in New York City to recruit participants; b) to gather and evaluate information about the feasibility, acceptability and safety of the intervention, in particular when implemented via remote delivery; c) to identify whether the clinical and content adaptations that were made during the remote training, adaptation and conduct of initial practice cases are appropriate for the setting; and d) to assess possible problems of recruitment, delivery of the intervention and retention to ensure that procedures are adequate for a cluster randomized control trial. Additionally, the investigators will employ a single-arm, uncontrolled design in order to begin to examine the effectiveness and impact of remotely delivered PM+ among community members in New York City who are experiencing symptoms of common mental health problems. Lastly, trainees' knowledge and perceived self-efficacy in a) foundational helping skills based on common therapeutic factors and b) intervention-specific competencies will be evaluated pre-training, post-training and post-supervision.
- Conditions
- Depression, Anxiety Disorders, Psychological Distress
- Being tested
- Remote Problem Management Plus
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Problem Management PlusBehavioural
Five sessions of low-intensity, trans-diagnostic psychological intervention including the teaching and practice of the following strategies: stress management, problem solving, behavioral activation, and strengthening social support
| Study group | Role | What they receive |
|---|---|---|
| Remote Problem Management Plus | Experimental | Five individual sessions of low-intensity psychological intervention Receives: Behavioral: Remote Problem Management Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Outcomes Profile; Unabbreviated scale title "Psychological Outcomes Profile"
4-item measure of personalized distress and client-generated problems, function and wellbeing; minimum value = 0, maximum value = 20; higher scores mean greater distress
Measured: 1 week post-intervention
Patient Health Questionnaire; Unabbreviated scale title "Patient Health Questionnaire"
9-item measure of depression symptoms; minimum value = 0, maximum value = 27; higher scores mean more severe depression symptoms
Measured: 1 week post-intervention
Generalized Anxiety Disorder Scale; Unabbreviated scale title "Generalized Anxiety Disorder 7-item Scale"
7-item measure of anxiety symptoms; minimum value = 0 and maximum value = 21; higher scores mean more severe anxiety symptoms
Measured: 1 week post-intervention
Secondary outcomes (5)
World Health Organization Disability Assessment Scale 2.0; Unabbreviated scale title "World Health Organization Disability Assessment Scale 2.0"
12-item measure of ability to engage in daily activities and functioning; minimum value = 0, maximum value = 48; higher scores mean worse disability outcomes
Measured: 1 week post-intervention
World Health Organization Quality of Life Questionnaire-BREF; Unabbreviated scale title "World Health Organization Quality of Life Questionnaire-BREF"
26-item quality of life assessment of physical health, psychological health, social, relationships and environment; minimum value = 26 and maximum value = 130; higher scores mean better quality of life
Measured: 1 week post-intervention
EuroQoL 5-dimension 5-level; Unabbreviated scale title "EuroQoL 5-dimension 5-level"
5-item assessment of dimensions of health status: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; minimum= 5, maximum = 25; higher score mean worse health outcomes
Measured: 1 week post-intervention
Pittsburgh Sleep Quality Index; Unabbreviated scale title "Pittsburgh Sleep Quality Index"
19-item measure of sleep quality and disturbance; 19 items combined to form 7 "component" scores, each of which has a range of 0-3 points, 7 component scores are added to yield one global global score; minimum value = 0 and maximum value = 21; higher score means greater difficulty sleeping
Measured: 1 week post-intervention
Somatic Symptom Scale-8; Unabbreviated scale title "Somatic Symptom Scale-8"
8-item assessment of the presence and severity of common somatic symptoms; minimum value = 0, maximum value = 32; higher score means more severe somatic symptoms
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start4 Mar 2021
- Primary completion20 Feb 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New School
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Sponsor
- Investigators
- Adam Brown, PhD, Principal investigator, The New SchoolBrandon Kohrt, MD, PhD, Study director, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617262
- Sponsor's protocol ID
- 2020-91-PM+
- Acronym
- PM+
- Status last verified
- May 2024
- First submitted
- 2 Nov 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data will be available through National Institute of Mental Health Data Archive after publication of primary results.
Publications
Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.
PubMed 28809935Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.
PubMed 27863515Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
PubMed 27265713Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
PubMed 26407793
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Remote Problem Management Plus to Improve Well-being and Functioning of Adults Affected by COVID-
- ClinicalTrials.gov ID
- NCT04617262
- Acronym / sponsor ID
- PM+ / 2020-91-PM+
- Conditions
- Depression, Anxiety Disorders, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The New SchoolUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 5 Nov 2020 (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.
This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.
Detailed description
Problem Management Plus (PM+) is recommended as part of the World Health Organization Mental Health Gap Action Program for communities affected by adversity. It is a low-intensity, scalable manualized intervention that was designed according to a task-sharing model of care. PM+ has four core features that make the intervention suitable for populations exposed to adversities in low-resource settings. First, it is a brief intervention (five sessions); second, it can be delivered by paraprofessionals (trained, non-specialist workers, lay or peer providers under the supervision of a mental health professional), using the principle of task shifting/task sharing; third, it is designed as a trans-diagnostic intervention to address a range of client-identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; and, fourth, it is designed for communities affected by any kind of adversity (e.g. violence, disasters) in low-income countries. The intervention was originally developed for adults affected by humanitarian crises and tested in low-income countries. A number of randomized controlled trials in Kenya, Pakistan, Nepal, as well as the Netherlands have indicated that PM+ delivered by non-specialist helpers is effective in decreasing symptoms of psychological distress (including depression, anxiety and post-traumatic stress disorder symptoms) and improving functioning; however, empirical evidence of the feasibility and efficacy of the remote training and delivery of PM+ is limited.
In May 2020, the United Nations released a policy brief emphasizing inclusion of mental health and psychosocial support (MHPSS) in national response plans including scaling up access to remote support (UN, 2020). The brief was released in response to emerging concerns of the negative mental health and psychosocial impacts arising from the health and societal consequences of COVID-19. Extant population-based research is showing high rates of anxiety, depression, and general distress in the US, while at the same time MHPSS provision has been disrupted or halted due to social distancing measures. Remote delivery forms of PM+ may serve as an important mechanism to facilitate access to care during the ongoing pandemic and into the future. Furthermore, there is very limited research with PM+ in high-income countries where specialized mental health interventions are available, but where access for certain populations or during periods of public health crisis is limited due to systemic and practical barriers. Even in high income countries, only 22.4% of those with depression receive minimally adequate care; however, 64.9% of those with depression perceive a need for treatment. The treatment gap may be considerably higher among marginalized groups and economically disadvantaged communities. COVID-19 continues to bring on widespread mental health disparities, particularly among vulnerable and underserved communities that are disproportionately affected by COVID-19. Brief, low-intensity interventions designed to be implemented by non-specialists represent a promising and scalable approach to minimize this treatment gap in under-served US populations by partnering with community-based organizations (CBO) to train and supervise staff already involved in social and public health services. An important first step before investing resources in training and implementation with CBOs is to evaluate the feasibility, acceptability and effectiveness of remotely delivered PM+ with relevant community samples.
This is the first study to evaluate remotely delivered PM+ implemented by helpers whose training and supervision was conducted entirely online, as well as one of the first trials evaluating PM+ with community samples in the US. The aims of this pilot feasibility study are to a) assess interest from perspective beneficiaries by partnering with community-based organizations in New York City to recruit participants; b) to gather and evaluate information about the feasibility, acceptability and safety of the intervention, in particular when implemented via remote delivery; c) to identify whether the clinical and content adaptations that were made during the remote training, adaptation and conduct of initial practice cases are appropriate for the setting; and d) to assess possible problems of recruitment, delivery of the intervention and retention to ensure that procedures are adequate for a cluster randomized control trial. Additionally, the investigators will employ a single-arm, uncontrolled design in order to begin to examine the effectiveness and impact of remotely delivered PM+ among community members in New York City who are experiencing symptoms of common mental health problems. Lastly, trainees' knowledge and perceived self-efficacy in a) foundational helping skills based on common therapeutic factors and b) intervention-specific competencies will be evaluated pre-training, post-training and post-supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Problem Management Plus | Experimental | Behavioral: Remote Problem Management PlusFive individual sessions of low-intensity psychological intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Help- or treatment-seeking
- Access to a device for conducting sessions via Zoom (e.g., smartphone, tablet, laptop or personal computer)
Key exclusion criteria (4 listed)
- Acute medical conditions or severe cognitive impairment (e.g., severe intellectual disability or dementia)
- Imminent suicide risk or expressed acute needs/protection risks (e.g., intimate partner violence risk)
- Presence of severe mental disorder (e.g., psychotic disorders)
- Hazardous substance use, substance dependency or substance use disorder (assessed using the Drug Abuse Screening Test (DAST-10) and Alcohol Use Disorders Identification Test (AUDIT-C)
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 |
|---|---|---|
| Remote Problem Management PlusFive sessions of low-intensity, trans-diagnostic psychological intervention including the teaching and practice of the following strategies: stress management, problem solving, behavioral activation, and strengthening social support | Behavioural | Remote Problem Management Plus |
Primary outcome
Psychological Outcomes Profile; Unabbreviated scale title "Psychological Outcomes Profile"
Time frame: 1 week post-intervention
4-item measure of personalized distress and client-generated problems, function and wellbeing; minimum value = 0, maximum value = 20; higher scores mean greater distress
Patient Health Questionnaire; Unabbreviated scale title "Patient Health Questionnaire"
Time frame: 1 week post-intervention
9-item measure of depression symptoms; minimum value = 0, maximum value = 27; higher scores mean more severe depression symptoms
Generalized Anxiety Disorder Scale; Unabbreviated scale title "Generalized Anxiety Disorder 7-item Scale"
Time frame: 1 week post-intervention
7-item measure of anxiety symptoms; minimum value = 0 and maximum value = 21; higher scores mean more severe anxiety symptoms
5 secondary outcomes
World Health Organization Disability Assessment Scale 2.0; Unabbreviated scale title "World Health Organization Disability Assessment Scale 2.0"
Time frame: 1 week post-intervention
World Health Organization Quality of Life Questionnaire-BREF; Unabbreviated scale title "World Health Organization Quality of Life Questionnaire-BREF"
Time frame: 1 week post-intervention
EuroQoL 5-dimension 5-level; Unabbreviated scale title "EuroQoL 5-dimension 5-level"
Time frame: 1 week post-intervention
Pittsburgh Sleep Quality Index; Unabbreviated scale title "Pittsburgh Sleep Quality Index"
Time frame: 1 week post-intervention
Somatic Symptom Scale-8; Unabbreviated scale title "Somatic Symptom Scale-8"
Time frame: 1 week post-intervention
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 22 May 2024.
- Background: PubMed 28809935Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.
- Background: PubMed 27863515Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.
- Background: PubMed 27265713Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
- Background: PubMed 26407793Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual patient data will be available through National Institute of Mental Health Data Archive after publication of primary results.
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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.
Adam Brown, PhD principal investigator
The New School
Brandon Kohrt, MD, PhD study director
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Problem Management Plus in people with Depression and Anxiety Disorders, run by The New School 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 3 inclusion and 4 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 22 May 2024. 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?
Psychological Outcomes Profile; Unabbreviated scale title "Psychological Outcomes Profile" (time frame: 1 week post-intervention). 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 NCT04617262, which also lists 4 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 22 May 2024.