AzTrials
AzTrials

Mental Health Wellness 1NCT04982094

Counting On U: Towards Better Mental Health

A study testing Mental Health First Aid and Relationship Building Training and Mental Health First Aid in people with Mental Health Wellness 1, run by Leanne Saxon at 1 site in Australia.

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

The financial state of a business and the mental health of the business owner are closely related. Thus, the devastating impact of COVID-19 on businesses means small-medium enterprises (SMEs) owners are particularly vulnerable to experiencing depression, anxiety and other mental health conditions (MHC). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Mental Health First Aid and Relationship Building Training and Mental Health First Aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,599 participants
Where
1 siteAustralia
Study dates
1 Mar 2021to 30 Sep 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Any qualified business advisor from Australia or New Zealand who provides business advice to a small-medium enterprise client (SME). Business advice refers to the information, guidance and/or assistance provided by an external adviser that either directly or indirectly helps to prevent/reduce the financial pressures experienced by SME owner-clients.
  • The SME client must be the owner-manager/operator with 1-199 employees, including the owner-manager themselves.
  • The business advisor must be in contact with their SME client at least 3 times a year.

Who cannot join

  • Any business advisor who has completed Mental Health First Aid within the last two years.

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Deakin University

    Burwood, Victoria, 3125

Other trials in Australia

About this study

Official title: Counting On U: Supporting SME Advisors and Owners Towards Better Mental Health

The financial state of a business and the mental health of the business owner are closely related. Thus, the devastating impact of COVID-19 on businesses means small-medium enterprises (SMEs) owners are particularly vulnerable to experiencing depression, anxiety and other mental health conditions (MHC). However, there is a tendency for SME owners to seek help about their financial concerns, rather than their mental wellbeing. For this reason, trusted business advisors (accountants, bookkeepers, coaches) who engage with their SME clients on a regular basis, are well-placed to provide advice about both the financial and mental health concerns of their SME clients.

To provide business advisors with the skills they need to have a conversation with their clients about their mental wellbeing and to encourage help-seeking where appropriate, mental health first aid (MHFA) training will be offered. And to help the business advisor forge a more trusting relationship with their client and provide higher quality advice that may alleviate their financial stresses, Relationship Building Training (RBT) will also be provided. Thus, the aim of this randomised control trial is to assess the additional benefit of combining RBT with MHFA compared with MHFA alone on the financial wellbeing of SME clients and the quality of their relationship with their business advisor.

Read the detailed description

The widespread lockdown of broader society experienced around the world due to the COVID-190 pandemic is unprecedented. Businesses in a variety of sectors such as manufacturing, retail, and hospitality were closed due to lockdown rules, a decrease in demand, health concerns or other factors. Many of the closures are permanent because of the inability of business owners to pay ongoing expenses and market uncertainty.

Small to medium enterprises (SMEs) account for 99% of all businesses in Australia and at least 95% of enterprises in all OECD countries. SMEs provide an important contribution to Australia's growth in employment, with small businesses (including micro businesses) employing approximately 4.72 million people and accounting for 41 per cent of total employment. To help citizens survive the pandemic, the Australian government provided financial support to employees via Job Keeper and cash flow boosts to eligible businesses. Nevertheless, some SME owners reported losing up to 90% of their income and continue to face ongoing challenges, including market uncertainty, loss of international skilled workers, lending restrictions, extensive legislative reform. At the same time that they're dealing with an increasingly difficult external environment, SME owners also have to content with running a business including monitoring cash flow, managing staff, and ensuring the smooth administration of the business.

Of the challenges faced by SME owners, financial pressure represents a major source of psychological distress and is likely to explain why SME owners generally experience higher levels of stress and mental health disorders compared with the broader population. In Australia, 1 in 3 SMEs rated their mental health as poor to fair during the pandemic. Identifying the symptoms of depression early and encouraging help seeking are therefore critical and cost-effective methods for protecting and promoting wellbeing.

Mental health literacy programs have emerged as a key strategy for the early identification of diagnosable mental health problems. The strategy has proved to be popular in the frontline human service sectors (e.g., health care, social work) where MHFA can be used to help colleagues and members of the public who may be experiencing the signs of depression, anxiety and other mental health conditions (MHC's). However, little is known about the effectiveness of mental health literacy programs where SME owners are concerned. Reaching vast numbers of owner-managers in a systematic way is thought to be particularly difficult, partly because of the absence of viable intermediaries that have ongoing contact with this group, but also because of the typical characteristics of the SME owner's role (e.g., long working hours, burden of responsibility, isolation, obligation to work when sick), coupled with their lack of financial resources.

One sector that has the potential to act as an intermediary between small business and mental health services are business advisors, who include accountants, financial planners and financial counsellors. Business advisors are an important source of support for SME owners as their expertise is sought on a regular basis and clients can develop trusting, long-term relationships with their accountant. Previous work in this sector by Bond and colleagues has shown that MHFA training is an effective way of improving financial counsellors' ability to recognise mental health problems among clients and to provide appropriate support for help-seeking.

Despite the importance of mental health prevention programs like MHFA, these strategies are designed to reduce the impact of mental health conditions (i.e. secondary and tertiary prevention) rather than prevent them from occurring in the first instance (i.e., primary prevention). Longitudinal evidence causally implicates adverse psychosocial working conditions (e.g., excessive workloads, inadequate support) in the development of MHCs, such as depression. Thus, if business advisors can work to alleviate these stressors, they may also help prevent the onset of MHCs.

Therefore, the aim of the current project is to assess a new approach to undertaking MHFA training by incorporating a client-centred, Relationship Building Training (RBT) program that is designed to help business advisors better understand the business and personal needs of SME owners. If they better understand their needs, the business advisor can provide higher quality advice and in turn, reduce the financial stress of the SME owner. For any of this to happen, there needs to be a degree of trust generated between the business advisor and their SME client. According to Manister's trust equation, trustworthiness can be increased by improving how credible, reliable, and intimate you are and by decreasing your self-orientation. Thus, the RBT aims to equip the business advisor with the skills they need to enhance their intimacy and decrease their self-orientation. It is proposed, that if the business advisor builds a more trusting relationship with their clients that: i) it will reduce information asymmetry between the business advisor and client, enabling a better understanding of the SME's needs that leads to more personalised, tailed advice. In turn, this will alleviate the SME's financial stress and help prevent the onset of MHCs; and ii) it will allow the SME to feel more comfortable disclosing any financial concerns and/or mental health problems and when combined with the MHFA, the business advisor will better recognise the signs of MHCs and encourage them to seek help where appropriate.

Thus, this study represents a crucial next step in protecting the mental health of SME owners by assessing the incremental effectiveness of combining a primary prevention strategy (RBT) with the tertiary and secondary-level prevention approach of MHFA on the prevention of MHC's. It will be the first to assess the effectiveness of the approach through a randomised control trial (RCT) using a national sample of practising business advisors and their SME owner clients. Combined with the effectiveness trial, a process evaluation will be employed to identify the programs strengths and areas for improvement and to inform the expansion of this program to other sectors.

Being tested
Mental Health First Aid and Relationship Building Training, Mental Health First Aid
Keywords
Prevention, Mental Health, Accountants, Small business owner
Medical subject headings
Psychological Well-Being

What participants receive

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

  • Mental Health First Aid and Relationship Building TrainingBehavioural

    Also called MHFA and RBT

    Relationship Building Training (RBT) is a 2 hour training session conducted live over zoom, that aims to equip business advisors the communications skills they need to enhance trustworthiness and quality of the relationship with their clients.

    Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.

    Two Booster sessions are delivered 1- and 3-months after the last MHFA session that aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.

    Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program.

  • Mental Health First AidBehavioural

    Also called MHFA alone

    Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions in addition to online reading, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.

    MHFA online training is conducted two-weeks before the two MHFA sessions (with a 1 day break in between each MHFA). Two Booster sessions are delivered 1- and 3-months after the last MHFA session. The Booster sessions aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.

    Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program.

Study groups in NCT04982094
Study groupRoleWhat they receive
Mental Health First Aid and Relationship Building Training (MHFA+RBT)ExperimentalMental Health First Aid training in conjunction with Relationship Building Training.
Receives: Behavioral: Mental Health First Aid and Relationship Building Training
Mental Health First Aid (MHFA only)Active comparatorMental Health First Aid training alone.
Receives: Behavioral: Mental Health First Aid

What is being measured

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

  1. Change in the quality of the relationship between the small-medium business owner with the business advisor.

    Quality of the Relationship Questionnaire aims to measure the SME owner's satisfaction with the level of attention they are receiving from the business advisor, and the business advisor's belief about how much attention they are providing. For the business advisors, 10 items will be used, four are from the Relationship Flourishing Scale (Fowers et al. 2016) that has a Cronbach's alpha of 0.93, and six are from a newly developed tool by principal investigators (AN, GT) with factor loadings of 0.81 to 0.87. The SME's will answer the latter six items. All items are on a 7-point Likert scale (1 strongly disagree, 7 strongly agree) with a higher total score indicating a stronger relationship.

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

Secondary outcomes (15)
  1. Process evaluation

    The RE-AIM framework will be used to guide our evaluation of the intervention (Counting on U) (Glasgow 1999). RE-AIM stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance. Field notes will be recorded, and structured interviews will be conducted with various stakeholders, including the business advisors, SME owners, trainers, and accounting/bookkeeper member bodies who will assist with the recruitment of business advisors. Process evaluation of Counting on U will help inform: 1) the future expansion and implementation of this program to various populations and 2) reveal both strengths and areas for improvement of the program strategies.

    Measured: Baseline, mid-training, 5-months post training

  2. Change in psychological distress

    Psychological Distress of the SME owners and business advisors will be measured using the Kessler 6 (K6) (Kessler et al 2002). This non-specific scale screens individuals for severe mental illness as defined as a K6 score ≥13. The K6 asks respondents, in the past four weeks how often did they feel the following: nervous, hopeless, restless or fidgety, worthless, depressed and felt that everything was an effort. For each question, a value of zero to four is assigned (0 none of the time, 4 all of the time), and a total score summed out of 24. The scale has demonstrated excellent internal consistency and reliability (Cronbach's alpha = 0.89) (Kessler et al 2002).

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

  3. Change in MHFA knowledge

    Knowledge about mental health problems will be assessed using 18 questions adapted by Jorm et al (2010) that reviews information taught on day 1 and 2 of the Mental Health First Aid course. Questions consist of statements rated as Agree, Disagree or Unsure. The total score will be the number of questions answered correctly. An examples question is: "Half of all people who experience a mental illness have their first episode by age 18".

    Measured: BAs: Baseline, 1 + 5 months post training

  4. Change in confidence to provide MHFA

    Provision of Mental Health First Aid questions will include whether the business advisor had talked to a SME owner about their mental health problems over the past month using a 4-point Likert scale (1 never, 4 many times) (Jorm et al 2010). If they have talked with a SME owner client, they will be asked to indicate how many out of 12 actions they had taken. A score of 1 will be allocated to any action they have taken A Few or Many Times and summing these scores.

    Measured: BAs: Baseline, 1 + 5 months post training

  5. Change in stigmatisation

    Stigmatising attitude of the business advisors will be measured using six statements that queries their opinion of a person described in a vignette (personal stigma) (Reavley 2011). The modified vignette (Yap et al 2015) portrays a 35-year-old business owner who is showing signs of depression. An example of a personal stigma item is: "A problem like John's is a sign of personal weakness". Each item is scored on 5-point Likert scale (1 strongly agree, 5 strongly disagree) and the total score will be the number of items answered Agree or Strongly Agree.

    Measured: BAs: Baseline, 1 + 5 months post training

  6. Change in health seeking behaviour

    Actual Health Seeking Behaviour questions will assess the SME owners and business advisor's behaviour of actively seeking assistance for mental health problems (Rickwood et al. 2005). The scale covers the informal, formal as well as physical and emotional aspect of help-seeking behaviour. The participant is asked to select from a list of people they have gone to for advice or help in the past two weeks.

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

  7. Change in health, comfort, and happiness experienced by the individual (Quality of life).

    Quality of Life questions will measure the general health of the business advisors and SME owners. The Short Form-12 questionnaire (SF-12) produces two summary scores - a mental component score (MCS-12) and a physical component score (PCS-12). This questionnaire has a test re-test reliability of 0.76 to 0.89 for the mental (MCS-12) and physical (PCS-12) health components (Ware 1996). Both components can discriminate among groups known to differ in their physical and mental conditions, yielding relative validities of 0.63 to 1.07 (Ware 1996). The answers are weighted, and the results are presented in reference to the United States population profile at the time of the original publication in 1994. A higher score for MCS and PCS indicates a better health state.

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

  8. Change in financial wellbeing of small-medium enterprise (SME) owners

    Financial Wellbeing Questionnaire (Prawitz 2006) consists of 8 items designed to gather information on how positively the SME owners view their financial situation. Each answer is scored from 1 to 10, and the total is summed and divided by 8. A higher score indicates no financial distress/ high financial well-being. The internal reliability of the scale is robust with a Cronbach's alpha of 0.956 indicating that the items contributing to the measurement of financial well-being, consistently yielded similar results. Factor loadings ranged from 0.83 to 0.93, indicating the measurement of only one latent construct.

    Measured: SMEs: Baseline, 5 and 11 month post-training.

  9. Change in the degree of trust the small-medium business owner has in their business advisor

    Trust in Business Advisor Questionnaire measures the three elements of trust defined by Cherry et al. (2018): confidence, acting proactively and not exploiting vulnerabilities. In addition, the SME owner's confidence in the services (i.e., beyond compliance services) offered by the business advisor will be measured. Eleven questions will assess trust on a 5-point Likert scale (1 strongly disagree, 5 strongly agree) with a higher total score indicating a more trusting relationship. Factor loading for the items range from 0.43 to 0.95 and shows good reliability, with a Cronbach's alpha of 0.931 to 0.937.

    Measured: SMEs: Baseline, 5 + 11 months post training.

  10. Change in financial pressure

    Perceived Financial Wellbeing questions developed by Netemeyer et al 2018, asks the SME owners to consider how much they agree with 5 statements such as "I am behind with my finances". Their answers will be scored on a 5-point Likert scale (1 strongly agree, 5 strongly disagree) and a lower total mean score will indicate a more positive outlook. Perceived financial wellbeing is a strong predictor of overall well-being and has a Cronbach's alpha of 0.86 to 0.94 (Netemeyer et al. 2018).

    Measured: SMEs: Baseline, 5 + 11 months post training.

  11. Autonomy

    Autonomy will be measured using a 3-item scale that asks how much control the business advisor feels they have over their work and scored on a 5-point Likert scale (1 strongly disagree, 5 strongly agree) (Bakker et al, 2004, Karasek 1985). A mean score will be generated and a higher score indicating greater autonomy. The Cronbach's alpha is 0.68.

    Measured: BAs: Baseline + 5 months post training

  12. Emotional

    Emotional Demands on the business advisors will be measured using the second version of the Copenhagen Psychosocial Questionnaire (Pejtersen et al, 2010). There are four items exploring how emotionally demanding they find their work, two items are measured on one 5-point Likert scale (1 never, hardly, 5 always) and two on a different 5-point Likert scale (1 to a very small extent, 5 to a large extent). The Cronbach's alpha is 0.87.

    Measured: BAs: Baseline, + 5 months post training

  13. Workload

    Workload of the business advisors will be measuring using 3 items on a 5-point scale (1, not at all, 5 to a great extent) (Albrecht 2015, Karasek 1979). They will be asked their thoughts on statements such as "to what extent is there not enough time for you to do your job?" A mean score will be generated, and a higher score indicates a more demanding workload. The Cronbach's alpha is: 0.85 to 0.88.

    Measured: BAs: Baseline + 5 months post training

  14. Confidence and resilience

    Psychological Capital Short Form (PCQ-12) questionnaire measures wellbeing as a function of four emotions, two of which will be measured in the SME owners and business advisors: resilience and self-efficacy (Kamei et al 2018). Participants will respond to six statements on a 6-point Likert scale (1 strongly disagree, 6 strongly agree). PCQ-12 is designed for working adults and both resilience and self-efficacy statements are significantly correlated with measures of satisfaction with life, happiness and perceived stress (-0.36 to 0.50). The factor loadings of the questions range from 0.30 to 0.87.

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: 1 + 5 months post training

  15. Social support

    Social Support questions assess the extent of emotional social support the participant receives from clients, family and friends, or colleagues and peers (Totterdal et al. 2006). The business advisors and SME owners will be asked two questions about each source: how easy is to talk to the people concerned and are the people concerned willing to listen to your problems. Responses are recorded on a 5-point Likert scale (1 not at all, 5 a great deal). The higher the score, the higher the social support. The Cronbach's alpha is 0.81.

    Measured: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline + 5 months post training

Timeline

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

  1. First posted29 Jul 2021
  2. Study start1 Mar 2021
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised Controlled Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982094
Sponsor's protocol ID
2020-399
Status last verified
Mar 2024
First submitted
21 Jun 2021
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prawitz AD, Garman T, Sorhaindo B, O'Neill B, Kim J, Drentea P InCharge Financial Distress/Financial Well-Being Scale: Development, Administration, and Score Interpretation

  • Mayer, R.C., Davis, J.H. and Schoorman, F.D. An integrative model of organizational trust. Academy of Management Review, 2005. 20(3): 709-734.

  • Cherry M, McGrath D, Baumann C.Client intimacy & performance advice: Determinants of trust in the public accountant SME client relationship.Australasian Accounting, Business and Finance Journal. 2018; 12(1): 3-32

  • Coulter K, Coulter R. Determinants of trust in a service provider: the moderating role of length of relationship. Journal of Services Marketing. 2002; 16(1): 35-50.

  • Fowers BJ, Laurenceau JP, Penfield RD, Cohen LM, Lang SF, Owenz MB, Pasipandoya E. Enhancing relationship quality measurement: The development of the Relationship Flourishing Scale. J Fam Psychol. 2016 Dec;30(8):997-1007. doi: 10.1037/fam0000263.

    PubMed 27918187
  • Jorm AF, Kitchener BA, Fischer JA, Cvetkovski S. Mental health first aid training by e-learning: a randomized controlled trial. Aust N Z J Psychiatry. 2010 Dec;44(12):1072-81. doi: 10.3109/00048674.2010.516426.

    PubMed 21070103
  • Netemeyer RG, Warmath D, Fernandes D, Lynch GJ Jr. How Am I Doing? Perceived Financial Well-Being, Its Potential Antecedents, and Its Relation to Overall Well-Being Journal of Consumer Research. 2018; 45(1) 68-89,

  • Totterdell P, Wood S, Wall T. An intra-individual test of the demands-control model: A weekly diary study of psychological strain in portfolio workers. Journal of Occupational and Organizational Psychology. 2006;79, 63-84

  • Landells EM, Albrecht SL. Perceived Organizational Politics, Engagement, and Stress: The Mediating Influence of Meaningful Work. Front Psychol. 2019 Jul 10;10:1612. doi: 10.3389/fpsyg.2019.01612. eCollection 2019.

    PubMed 31354596
  • Albrecht SL. Job resources and employee engagement in a Chinese context: the mediating role of job meaningfulness, felt obligation and positive mood. International Journal of Business and Emerging Markets. January 2012

  • Bakker AB, Demerouti E, Verbeke W. Using the job demands-resources model to predict burnout and performance. Human Resource Management. Spring 2004; 43(1):83-104

  • Pejtersen JH, Kristensen TS, Borg V, Bjorner JB. The second version of the Copenhagen Psychosocial Questionnaire. Scand J Public Health. 2010 Feb;38(3 Suppl):8-24. doi: 10.1177/1403494809349858.

    PubMed 21172767
  • Albrecht SL. Challenge Demands, Hindrance Demands, and Psychological Need Satisfaction Their Influence on Employee Engagement and Emotional Exhaustion. Journal of Personnel Psychology 2015; 14(2):70-79

  • Karasek RA. Job demands, job decision latitude, and mental strain: Implications for job redesign. Administrative Science Quarterly. 1979: 24: 285-308.

  • Cocker F, Martin A, Scott J, Venn A, Sanderson K. Psychological distress, related work attendance, and productivity loss in small-to-medium enterprise owner/managers. Int J Environ Res Public Health. 2013 Oct 15;10(10):5062-82. doi: 10.3390/ijerph10105062.

    PubMed 24132134

Questions about this trial

What is this clinical trial studying?

A study testing Mental Health First Aid and Relationship Building Training and Mental Health First Aid in people with Mental Health Wellness 1, run by Leanne Saxon at 1 site in Australia.

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 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 29 Mar 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 Australia. 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?

Change in the quality of the relationship between the small-medium business owner with the business advisor. (time frame: SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training). 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 NCT04982094, which also lists 43 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 29 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in