In parts one and two of this series, we introduced our research mission and the role of efficacy research. We explained the thinking behind our research roadmap, and delved into some of our research plans for 2021. This final part illustrates some of the best practices we apply to ensure we’re conducting research in a way that’s ethical, responsible and trustworthy.
What do we mean by research best practice?
When we’re planning and conducting studies, we follow guidelines on research best practice. We’ll focus here on two specific areas. The first relates to the experience of our participants. We’ll explain how we ensure that participants are safe, well-informed, and their data is managed securely. Then we’ll highlight how we produce and share our findings in a trustworthy way, such as through using appropriate study designs and collaborating with academic institutions.
How do we ensure a safe and confidential experience for participants?
It’s important that our studies are safe and we minimise any risks to participants, in keeping with research ethical standards. Before we can launch a new study, all of our planned methods are reviewed and approved by a University Research Ethics Committee.
Providing detailed study information, voluntary participation, and informed consent
We want to ensure participants can make an informed choice when deciding whether to take part in one of our studies.
As we covered in part two, we recruit all participants externally, and they’ve never used the Unmind platform before.
We give potential participants detailed information about a study before they sign up, using language that’s easy to understand. We explain the study’s aims, what’s involved, any potential risks and benefits involved in taking part, and how we’ll collect and manage participants’ data. We then ask them to sign a consent form. Although participants receive a small payment for their time, their participation is always voluntary.
Confidentiality and data protection
We take confidentiality really seriously. In line with data protection regulations (such as the EU General Data Protection Regulation (GDPR)), we assign each participant a unique identifier (a 24-digit alphanumeric code), so that we don’t need to access any personally identifiable information, like names and email addresses. Everyone remains anonymous within our analyses.
Withdrawing participation and data
Participants can withdraw from our studies, or request that their data is removed at any stage, without needing to give a reason. This is standard practice in research.
How do we produce and share our findings in a trustworthy manner?
We take many steps to ensure that our research is trustworthy. This is integral to being able to use our research findings to evolve the Unmind platform and have the greatest impact on the mental health and wellbeing of our users. These steps involve us following official guidelines on study design and sharing findings. For example, CONSORT 2010 details how to report on clinical trial findings.
Rigorous design and analysis
Below are just a few examples of how our approach to design and analysis ensures we produce trustworthy study findings.
We advertise our studies to a diverse range of people, spanning age, gender, ethnicity, and so on.
We decide in advance which will be most important to our outcome(s) for each study, and measure these using valid and reliable standardised questionnaires. Our selected outcomes relate to topics that the National Institution for Health and Care Excellence (NICE) identify as important.
We use the 'gold standard' approach for our efficacy studies – randomised controlled trials (RCTs) – to maximise the reliability and validity of our findings.
We use pilot studies to assess and refine our methods before conducting full-scale trials. The is the recommended first step approach in the field of evaluating interventions.
It's generally expected in any efficacy study that some participants won't complete the intervention they’ve been asked to complete. When we analyse our study data, we include data from all participants who initially began the study, regardless of whether they completed the intervention they were asked to complete (known as an 'intention to treat analysis'.) This reduces bias and mirrors everyday practice, in which not everyone will complete interventions.
Impartiality and transparency
When we plan and carry out our studies, we collaborate with external academic institutions. The input of external experts – who are entirely impartial – adds greater credibility to our research process.
For our efficacy studies, we collaborator with Professor Kate Cavanagh at Sussex University. Kate is a clinical psychologist and a leading international expert in e-health.
Study pre-registration and sharing our findings
As you may remember from part one, making our methods and findings transparent and widely accessible is the fourth pillar of our research mission.
We pre-register each study with an online registry before we launch the study. In doing so, we commit in advance to how we‘ll conduct the study, and to our aims, hypotheses and the outcomes we will measure. This prevents us from being able to cherry-pick the results we share, or from changing our approach part way through a study to biasedly find results in favour of the Unmind platform.
This means you can be sure that the findings we share with you are credible and honest. Similarly, we aim to publish all of our research in peer-reviewed academic journals regardless of the study’s findings. We’ll also share our findings with Unmind users, clients, and the wider non-academic community.
And that's all, folks! Over this three-part series, we hope to have:
- Given you some insight into the research mission that guides the work of the psychology team at Unmind.
- Helped you understand the role and importance of efficacy research in digital mental health.
- Highlighted the work involved in the development of our research roadmap.
- Revealed how we conduct research in a way that’s ethical, responsible and trustworthy.
- Left you feeling excited about our current studies and some of our upcoming plans for 2021!
Find out more about Unmind
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