How to recruit for mental health trials: the step-by-step guide to trial success

By Gabrielle Platt, Content Marketing Manager at Clariness

Over 970 million people worldwide live with a mental health condition highlighting the urgent need to prioritize mental health on a global scale. In honor of World Mental Health Day (10th October), we are sharing the best practices for recruiting participants for trials focused on mental health.

Severe mental health conditions reduce life expectancy by up to 20 years, and account for 1 in every 6 years lived with disability. At Clariness, we have supported over 15 mental health clinical trials, successfully navigating the complex nature of patient recruitment for mental health conditions.

Visit our psychiatry therapeutic area page to learn more about how we support depression, PTSD, schizophrenia, borderline personality disorder and ADHD studies.

Contents

In this blog we’ll give you our step-by-step guide to recruiting for mental health clinical trials, including such advice as:

  1. Become an indication expert
  2. Prioritize diversity – Mental health conditions have an outsized impact in underrepresented patient groups
  3. Build trust – remove stigma
  4. Understand patient motivators and barriers to participation  
  5. Go hybrid 
  6. Use online channels to reach patients most effectively and tailor your advertisements

1. Become an indication expert

Although mental health clinical trials fall under the broader field of psychiatry, each condition presents distinct barriers and opportunities for patient participation. Understanding these nuances and planning your recruitment efforts accordingly is key to crafting effective recruitment campaigns.

In this step, we compare what we have learnt in our experience with schizophrenia, major depressive disorder (MDD) and PTSD trials. MDD clinical trials, with broader inclusion and exclusion criteria, are comparatively cheaper than trials for other mental health conditions. Further, they are typically easier to find an initial pool of interested patients, but critically, it is usually harder to convert interested patients with MDD than patients with schizophrenia or PTSD. This is due to the sheer size and varied demographic of the MDD patient pool, which is widespread among every age, gender, and ethnicity worldwide. MDD is a broad and less specified cohort which requires more sophisticated campaigns and precise targeting based on your specific study protocol to convert this broad audience to fit into your eligible patient pool.

Schizophrenia clinical trials are among the most expensive to recruit for, given the severity of the condition, the inherent disability it entails and the need to recruit patients with varying symptoms and severities. Additionally, these trials often require the participation of a ‘trial buddy’ or caregiver. A lack of time has been cited as the number one reason for refusal or dropout when recruiting family caregivers for clinical trials. The use of aspects of decentralized trials such as online and phone pre-screening and remote trial participation can alleviate these barriers for people already living with large responsibilities. Studies suggest replacing the term ‘caregiver’ with ‘care provider’ has been shown to increase recruitment rates of this demographic.

When recruiting for clinical trials, it is important to consider the co-morbidities or circumstances that may affect eligibility. Drug abuse is often higher in the mental health patient population and is also a common exclusion criterion. We can often expect family or caregivers to seek out alternate treatment options via clinical trials when loved ones are having an acute episode of psychosis or depression that requires hospitalization or institutionalization. Most drug intervention trials exclude these patients.

In our experience, PTSD clinical trials are less expensive and easier to recruit than MDD clinical trials, due to the higher online engagement of participants. This year, we contributed 65% of total enrolled patients for a PTSD study in Germany using our online portal ClinLife® to capitalize on this high online engagement to drive over 3,000 organic visits to the study page.

It is crucial that trial organizers do not treat all mental health clinical trials as the same. The differences are clear, and by understanding the nuances of each indication trials will meet randomization targets faster and at a lower cost than applying a blanket approach.

2. Prioritize diversity: Mental health conditions have an outsized impact in underrepresented patient groups

Mental health conditions affect everyone, everywhere. Unfortunately, the same groups that are most commonly underrepresented in clinical trials, are those who can suffer most from mental health conditions. For instance, LGBTQIA+ people are often underrepresented in clinical trials, and experience mental health conditions at a rate 1.5x higher than the general population, with 50% having experienced depression. Lesbian, gay, and bisexual people are twice as likely to have been diagnosed with a mental health condition in the last 12 months than heterosexual people.

Studies have proven the link between sexual minority status and mental health conditions, due to the stigma-based discrimination such as homophobia, transphobia, and social isolation these communities can face. It is encouraging that in a recent survey of over 6,000 people in 9 countries conducted by Clariness, 73% of LGBTQIA+ respondents indicated their willingness to participate in clinical trials. To successfully recruit these patients, it’s essential to address the barriers to their participation and capitalize on the factors that motivate them to get involved.

Centering trust and community increases participation among transgender people, with research suggesting increasing visibility of transgender people in clinical trials, such as by using inclusive medical reporting and language, having transgender staff and using recommendations of trusted clinicians is key to increasing trans participation. Altruism and the betterment of health outcomes for their community is a major driver for LGBTQIA+ participation, along with the use of trusted patient advocacy groups, and allaying of financial and psychological barriers to participation.

You can learn more about this topic in our blog on increasing participation of LGBTQIA+ people in clinical trials as well as increasing representation of African American patients in clinical trials.

In positive news for improving representation of women in clinical trials, we have seen women engage with mental health clinical trials at a much higher rate than men. Across our ADHD, schizophrenia, borderline personality disorder and MDD studies, women responded to more online questionnaires than men, and some trial advertisements saw women engage at a rate of 74.92%, compared to just 25% engagement from men. Women tend to respond at higher rates to social media advertisements and are more likely to self-report mental health symptoms. To learn more about prioritizing women’s participation in clinical trials, read our women’s health resource here.

3. Build trust – remove stigma

Over half of people living with mental health conditions do not receive treatment for their illness.

People living with mental health conditions can experience discrimination and stigma. Stigma can come in the form of public stigma through stereotypes and discrimination, self-stigma through internalized shame of living with a mental health condition, which can harm a patient’s chance of recovery and structural stigma, that takes the form of underfunding of mental health clinical research, or healthcare services in comparison to other conditions.

This stigma can lead to a reluctance to seek treatment, a lower likelihood to follow through with treatment and a distrust of healthcare settings.

International trials can be impacted by the diverse cultural approaches to and attitudes towards mental health, which can affect diagnosis rates, potentially limiting your patient pool. For example, distrust for medical institutions due to structural racism and discrimination can impact African American people from seeking treatment, while in some Asian cultures avoiding shame and a focus on strong family values can be a deterrent to seeking professional treatment.

To enhance participation in mental health clinical trials, it is crucial to establish trust with patients. Many patients may feel hesitant to trust unfamiliar researchers when it comes to sharing sensitive personal information. Additionally, they may worry that the trial questions could be perceived as intrusive. Pre-screening patients with a mental health condition requires dedicated backup processes and specially trained staff to deal with sensitive topics like drug abuse and suicidal ideation. By fostering a trained, supportive, and understanding environment, researchers can help alleviate these concerns and encourage greater involvement in mental health studies.

At Clariness, we work closely with patients to build trust. We do so by always prioritizing a patient-centric focus. We partner with trusted clinicians and patient advocacy groups, actively listen to patients and their fears and needs through patient surveys, get patient feedback on trial design, provide easy-to-understand educational materials and personalized follow ups through our in-house Enrollment Success Team who engage with patients in their local language.

 4. Understand patient motivators and barriers to participation 

Every indication brings its unique recruitment challenges. To achieve success, it is essential to gain a comprehensive understanding of your patient population – their motivations, fears, and hesitations. Adopting a patient-centric approach in both your trial design and recruitment strategy is crucial for fostering engagement and participation.

Patients in mental health clinical trials display a strong sense of patient preference; patients in MDD clinical trials, for example, show a stronger preference for trials with less invasive and less frequent assessments, and fewer and shorter study procedures. Patients may be less willing to disclose the necessary private contact information needed for recruitment, and consent forms may be unnerving.

Studies have shown that a ‘fear of embarrassment’ has been named as a concern keeping people with MDD from participating in MDD studies, while they are less likely to participate in trials that may exacerbate their condition or include a placebo, ‘authorized deceptive design’ or ‘post-hoc deceptive design’.

With schizophrenia, patients may be at different steps in their diagnosis journey, and unsure of a formal diagnosis. In a schizophrenia clinical trial for one of the world’s top 20 largest pharmaceutical companies, we supported 36 sites over 5 months across 7 European countries. For this trial we expanded eligibility to schizophrenia patients who are undergoing diagnosis and not yet formally diagnosed to broaden eligibility. This approach allowed us to broaden our reach while ensuring that eligibility was verified by trial physicians.

In our support of a PTSD clinical trial across 4 sites in Germany for a top 20 international pharmaceutical company, we discovered that one challenge to participation can be that patients and those around them may not be aware of PTSD symptoms, with patients needing to receive more information about how the study can benefit them.

Interestingly, patient motivations for participating in MDD clinical trials buck the trend of other indications where altruism is the major incentive. In MDD clinical trials, patients are motivated most by finding a treatment to improve their own condition.

5. Go hybrid

We have found that hybrid trials work best for mental health indications. By combining the advantages of decentralized trials – the ability for patients to bypass barriers around transportation to trials, in-person time demands, financial burdens and inconvenient scheduling times with the proven success of telehealth, recruitment through social media and online channels, and online and phone pre-screenings. Combining these benefits with the benefits of personalized, trusted human follow ups sees mental health clinical trials through to success.

In September this year, the FDA published its final guidance on decentralized clinical trials, encouraging a shift to decentralized clinical trial framework, promoting a distributed model where study-related activities can take place at sites, remotely via telehealth, at patient’s homes, health care provider offices or pharmacies. The FDA guidance notes that digital health technologies have progressed the capabilities of remote study methods and includes the recommendation for trial staff to train patients and health care providers on the study methods and data collection to minimize variables.

Hybrid trials are best for therapeutic areas such as psychiatry that are often considered ‘hard to recruit for’ therapeutic areas, with patient populations that are averse to many in-person site visits. As outlined above, we already know that patients in the psychiatry therapeutic area show strong patient preferences that mandate their participation, including stronger preference for trials with less invasive and less frequent assessments, and fewer and shorter study procedures. Hybrid trials deploying a mix of decentralization and traditional study methods allow this to be the case.

A place where hybrid trials excel is in the patient pre-screening follow up process.  To minimize patient drop-off, it is crucial to ensure prompt follow up immediately after online study registration. Patients with mental health conditions may be hesitant to answer calls from unfamiliar numbers, so establishing a clear line of communication is essential.

Our Enrollment Success Team has supported site performance and enrollment at over 7,000 sites and reaches patients within 20 minutes of registering for a study, or at their nominated time for phone pre-screening. In a recent PTSD study for a leading international pharmaceutical company, we achieved a reachability rate of 86%. Extensive hours of operation allow the Enrollment Success Team to follow up with patients so rapidly.

6. Use online channels to reach patients most effectively and tailor your advertisements

Unlike patients in other therapeutic areas, people with mental health conditions demonstrate a notably high level of online engagement and self-education about their condition. Online recruitment advertisements are proven to increase patient accessibility to clinical trials, reach large and varied demographics, and have higher ROI.

As global digital patient recruitment experts, we use a multichannel approach to online patient recruitment, using over 40 online channels. Monitoring and optimizing performance of online campaigns is essential to delivering eligible patients in a time and cost-effective manner. Before starting an online campaign, we build a qualitative and data-driven understanding of the study’s patient population, using insights we own and gather, in-house medical knowledge and past experiences.

Our ClinLife® patient portal capitalizes on the high online patient engagement of people living with mental health conditions by driving consistent patient traffic to study landing pages. For a top 20 international pharmaceutical company, we listed their entire portfolio of studies, including schizophrenia, MDD and PTSD studies, driving over 500,000 total indication landing page visits and 3,000 referrals, with the indication-based model driving patient traffic from day one and providing a consistent flow of referrals.

Studies, such as one targeting young veterans with PTSD, showed that social media can be the most effective tool for ‘hard to recruit for’ populations, although research shows that you should not rely completely on social media, as it can be more representative of female and younger respondents, if that is not your target group.  

A separate veteran mental health study found that people who responded to an online advertisement were 5 times more likely to consent to participate. Another study showed that people with mental health concerns may be more likely to respond to online surveys, versus postal surveys.

Online advertising is integral to our active recruitment patient recruitment strategy. We target patients based on their geo-location, demographics, behavior, and interests. In a recent study, we targeted patients with schizophrenia based on the common interests people living with schizophrenia tend to develop, such as meditation, yoga, watercolor painting, gardening, modern art, visual art, puzzles, and crosswords.

Targeting with keywords is integral to successful digital patient recruitment. Research suggests that people with MDD use more first-person singular pronouns and “absolutist” terms, using an excessive number of words that reflect negative feelings. While this of course cannot describe every person with MDD, when selecting keywords to target patients, it is useful to understand how people with MDD may use and respond to language online. To learn more about how our online advertising channels were 6x more cost-efficient than another vendors’ traditional channels in a MDD clinical trial, read our blog on how digital patient recruitment can reduce enrollment costs in MDD trials.

With mental health trials, it is particularly important to be selective in advertisement copy and deploy A/B testing. In the trials we have supported, advertisement wording is truly relevant. In some countries we avoided the use of the word “schizophrenia,” but instead chose alternate words to describe the condition, such as ‘psychosis sensitivity’ and those advertisements converted better in 3 European countries, due to less competition with the term ‘schizophrenia’. With schizophrenia clinical trials, in our experience we find that using illustrations in advertisements rather than images of real people convert better. This also emphasizes the importance of tailoring advertisements per indication.

If struggling to reach your target of study registrations, it is most important to focus on expanding your audience size and audience geo-targeting and advertisement radius than by diluting budgets by advertising on an increasing number of social channels.

In our online recruitment we also deploy lookalike targeting from previous studies and retargeting ads, activating, and deactivating ads based on site status to avoid overwhelming sites, now made easier with our Site Contact Center’s enhanced site visibility; which you can learn more about here.

Summary

Need a wrap-up of the steps to mental health clinical trial recruitment success?

We hope you found this blog useful. If you need help with your trial that is underway or are ready to start recruiting for your mental health clinical trial, get in touch with one of our patient recruitment experts today.

For more information and resources, visit our psychiatry therapeutic area page to explore how we can support your patient recruitment efforts.

Want to learn how we support your patient recruitment?

Contact us