Empowering voices: Inclusive research for people with Learning Disabilities

There is compelling evidence that people with learning disabilities are significantly more likely to experience mental health issues. The authors of multiple large-scale epidemiological studies report that 16-54 per cent of those with learning disabilities have mental health problems, including severe and enduring mental illnesses (Cooper et al., 2009a; Cooper et al., 2009b; Cooper et al., 2007a; Cooper et al., 2007b; Morgan et al., 2008; Rojahn & Meier, 2009). In stark contrast, the age-standardised prevalence of 12 mental health disorders amongst the general population has recently been estimated to be only 1.2 per cent (GBD 2019 Mental Disorders Collaborators, 2022).

This vulnerability is down to a combination of biological (e.g. genetic vulnerability), social (e.g. social exclusion, bullying, abuse), and psychological (e.g. interpersonal skills, coping ability) risk factors. Astonishingly, despite the high prevalence of mental health issues amongst this group, the evidence supporting the use of psychological interventions is limited and biased; there has been a lack of robust well-powered clinical trials investigating whether psychological interventions are effective (Graser et al., 2022; Koslowski et al., 2016; Tapp et al., 2023; Vereenooghe & Langdon, 2013). 

This situation presents a 'double hit' for those with learning disabilities: they face a higher risk of developing mental health problems, yet the evidence base for effective interventions is weak. To help understand this further and consider solutions, we spoke with people with learning disabilities, carers, and researchers about their experiences and perspectives of clinical trials testing psychological interventions for mental health issues. Their insights highlight the urgent need for more rigorous and inclusive clinical trials in this area to improve our evidence-base.

'No research about us without us'

Gary Bourlet, a self-advocate for people with learning disabilities and co-founder of Learning Disability England, alongside Dr Amy M. Russell from the University of Leeds, is spearheading an innovative research project titled 'No Research About Us Without Us'. Funded by the National Institute for Health and Care Research (NIHR), this project aims to break down the barriers preventing people with learning disabilities from participating in research.

We spoke with Gary and Amy to understand why so few clinical trials involving psychological therapies for people with learning disabilities have been successfully completed. They revealed that while many individuals with learning disabilities have transitioned from long-stay institutions to more independent living, gaining more autonomy, significant challenges remain when trying to engage them in research. 

One major hurdle is overprotectiveness, which often results in decisions about research participation being made on behalf of a person with learning disability. This well-intentioned but misguided approach hinders their independence and excludes them from the decision-making process. Instead of facilitating their inclusion and respecting their autonomy, it inadvertently perpetuates their exclusion from valuable research opportunities.

'Professionals and other individuals sometimes choose not to share information about clinical trials and research studies, or actively discourage participation,' explained Gary and Amy. 'This well-meaning protection is actually harmful, as it denies individuals their right to make their own choices. It's no longer acceptable to claim that someone with a learning disability is too vulnerable to take part in research. By not engaging them in discussions about research, we rob them of the chance to contribute and help others.'

Amy recounted her experience of working as part of a team that completed a feasibility trial involving people with learning disabilities and diabetes. However, they found that while not everyone understood the research, those who did were keen to participate and to be given a chance to help others (House et al., 2018). This underscores the importance of inclusive research practices that respect, inform, and thereby empower individuals with learning disabilities to decide for themselves whether they want to participate in research.

Gary emphasised the need for a shift in perception, stating 'We need a change in attitude. Healthcare professionals, carers, and supporters cannot assume that research is something that people with learning disabilities cannot do' as a participant or as a co-researcher. This belief underpins 'No Research About Us Without Us'. Together, Gary and Amy share leadership in their project, supporting their colleagues and co-leads who also have learning disabilities, moving beyond the idea of inclusion simply meaning participation. Gary proudly said, 'In our project, we have shown that people with learning disabilities can not only take part in research, but they can also lead it! And through shared leadership, the whole project was improved.' 

Their project underscores the importance of including people with learning disabilities in research, challenging the traditional gatekeeping practices that all too often exclude people with learning disabilities. By focusing on the benefits of research participation – including empowerment and a contribution to meaningful change, rather than solely being 'participants' – Gary and Amy advocate for a more inclusive approach that respects the capabilities and rights of individuals with learning disabilities. 

Voices unheard: The struggle to access evidence-based psychological therapy

We also spoke with a group of family carers involved in the Trauma-AID trial, a randomised controlled trial testing eye-movement desensitisation and reprocessing (EMDR) with adults with learning disabilities who have post-traumatic stress disorder (PTSD). This trial is funded by the NIHR and was previously led by Professor Paul Willner who unexpectedly passed away in 2023.  The trial is now led by your lead author, Professor Peter Langdon, and his team. 

Very few large-scale clinical trials like Trauma-AID have been funded nationally and internationally. Despite the considerable funding for this innovative trial, and the obvious potential benefits of the study, recruitment has been slower than anticipated. Participants are being recruited from across 12 NHS Trusts. Interestingly, two of the 12 NHS Trusts have successfully recruited nearly 50 per cent of the entire group of participants, while the remaining trusts have faced significant challenges in enrolling participants. This disparity highlights the need for targeted strategies to engage and include people with learning disabilities in research across our entire NHS, ensuring their voices and experiences are represented.

Given that the Trauma-AID trial is focused upon testing EMDR for PTSD, members of our carers group working with the researchers were eager to share their stories and those of their loved ones with learning disabilities. Their stories are told with permission. 

Henry's story

Rosemary shared the story of Henry, a much-loved son, brother, and friend. At 18, Henry was admitted to an assessment and treatment unit and never returned home, even though the family were told at the time that this would be for only 28 days. Now 30, Henry's ordeal began with repeated restraints and medications that impaired his ability to speak, move, and eat. His eventual transfer to an out-of-county facility exacerbated the situation. Having to cope with a two-hour journey to visit Henry, his family then learned after some time that Henry's autism diagnosis had been removed, and he had been arrested. This led to a serious case review, and the responsible clinician was referred to the General Medical Council (GMC). 

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Since leaving hospital, Ben has really loved being able to walk his dog

Eventually, Henry moved to a service closer to home, where his diagnosis of severe learning disability and autism was reinstated. Discharged and living in the community for six years now, Henry exhibits consistent trauma symptoms. He often pleads with and questions his care team and family: 'Don't let the ambulance take me away to a nasty hospital; what happened to the people who hurt me?'; 'Give me reassurance my bathroom door won't be locked'; 'How awful is it Mum to hold someone?' He has not been restrained since leaving the hospital and he is now supported in a safe environment, but Henry still lacks access to evidence-based psychological therapy for people with learning disabilities who have PTSD. 

Ben's story

Another powerful story comes from Ben's sister. Ben, who used to be a joyful young man playing his guitar and laughing, now often seems lost in a past filled with torment. In 2011, Ben endured abuse at Winterbourne View, where nursing staff kicked and punched him, and even broke his jaw. After being moved to another residential service, Ben faced further abuse; he was told that his mother was dead, and he was confined to an unheated cell-like room. Traumatised, even after he was moved, Ben would lash out and tremble at the sight of carers who resembled his abusers. 

It took nine years for Ben to be diagnosed with PTSD, but despite this, he has never received psychological therapy for his trauma. For a decade now, his family has struggled to support him, finding the lack of evidence-based psychological therapies for people with learning disabilities completely unacceptable.

Breaking barriers: The critical role of inclusive clinical trials

These distressing stories highlight the critical need for inclusive, trauma-informed care, access to evidence-based trauma-focused treatments and the importance of ensuring that individuals with learning disabilities are given the support and opportunities they deserve in research and healthcare. The families of Henry and Ben expressed unwavering support for clinical trials involving people with learning disabilities and have voiced the urgent need for evidence-based and adapted psychological therapies. Despite their profound needs, these families have been unable to access psychological therapy for people with learning disabilities who have PTSD because these therapies are not routinely available and there is a lack of robust evidence demonstrating efficacy and effectiveness.

The key issue here is evidence. Evidence can only be generated through well-designed and sufficiently large clinical trials that demonstrate causality; we need to show if psychological therapies work in an unbiased way. Members of our family carers group have consistently expressed their concerns about the scarcity of large clinical trials involving people with learning disabilities. This lack of evidence poses a significant barrier to informing future National Institute for Health and Care Excellence (NICE) Guidance on psychological therapies for people with learning disabilities.

Gatekeepers

Clinical trials involving people with learning disabilities require large, collaborative teams working across multiple sites. Success often hinges upon clinicians actively embedding the trial within their local services and/or multi-disciplinary teams. Unfortunately, people with learning disabilities are frequently excluded from these trials for reasons that are unclear, a practice that is wholly inappropriate (Feldman et al., 2014; McDonald et al., 2022). Efforts have been made to understand and address this discrimination. For instance, Mulhall et al. (2018) conducted a systematic review of randomised controlled trials involving people with learning disabilities to shed light on these challenges. They found that trials often struggle to recruit enough participants and rely heavily on gatekeepers for recruitment and retention.

Psychologists and other clinicians serve as key gatekeepers who can significantly promote the inclusion of people with learning disabilities in research on the one hand, or can prevent their recruitment and involvement, on the other. Their active involvement is crucial for the success of clinical trials testing psychological interventions. Carers and other significant people involved in the lives of people with learning disabilities also act as gatekeepers, playing an important facilitative or obstructing role in the recruitment of people with learning disabilities into clinical trials.

As researchers we often face the challenge of speaking to multiple gatekeepers, multiple times, before we get the opportunity to speak to someone with a learning disability and invite them to participate in a research study. It only takes one gatekeeper to make a decision that robs a person with a learning disability of such an opportunity.

The involvement of gatekeepers, whether they are health or social care professionals, or parents, family members or other carers, is essential for the inclusion and empowerment of people with learning disabilities. By fostering a more inclusive approach, gatekeepers can help ensure that research is representative and beneficial to those who need it most.

A related and noteworthy project funded by the Nuffield Foundation which focused upon developing a strategy for including adults with communication and/or capacity difficulties in research was completed at the University of East Anglia (Bunning et al., 2021). As part of a series of studies, the team conducted an online survey with 128 researchers who had submitted NHS Research Ethics applications invoking the Mental Capacity Act, 2005 and held 61 interviews with adults with learning disabilities, autism, mental health problems, brain injury and other disabilities, NHS Research Ethics Committee members, and researchers.

All stakeholders agreed that including adults with communication and/or capacity difficulties in research is essential to ensure high-quality studies that accurately represent their lived experiences. They also found that all stakeholders agreed that excluding people with disabilities from research is discriminatory. Individuals with disabilities themselves reported that participating in research provided them with a sense of achievement, increased confidence, and a feeling of usefulness (Killett et al., 2023).

Advocating for inclusion: The role of Psychologists in clinical trials

Going forward, as hopefully the NIHR commissions more clinical trials involving participants with learning disabilities, it is essential for all psychologists to actively engage and promote the genuine inclusion of people with learning disabilities in research. Psychologists have a duty to draw upon evidence to inform their clinical practice, while also involving service users in research, helping to create an evidence-base for our interventions.

The NHS Constitution for England states, 'The NHS aspires to the highest standards of excellence and professionalism…' and is committed 'to the promotion, conduct, and use of research to improve the current and future health and care of the population.'  A pledge within the Constitution to the public is that all NHS staff will inform people about '...research studies in which [they] may be eligible to participate' (Department of Health and Social Care, 2023).

Gary, Amy, and the families of Henry and Ben agree that it is time for all of us to not only actively advocate for the full inclusion of people with learning disabilities in clinical research, but to actually make this happen. For psychologists, this means actively getting involved in clinical research: become a local site principal investigator or a therapist working on a trial; take the time to share information about a study with someone with a learning disability; and work to tear down barriers that inhibit the inclusion of people with learning disabilities in clinical research. Find out about clinical studies that may be taking part and reach out and get in touch with the study team with a view to joining up!  

By doing so, all of us can collaboratively ensure that research is truly representative and capable of informing evidence-based practice that benefits people with learning disabilities. As we increasingly amass a robust evidence base about the efficacy and effectiveness of psychological interventions for people with learning disabilities, the benefits for people with learning disabilities are obvious, as are the benefits for psychologists and the psychology professions. As psychologists we have received intensive training to become scientist-practitioners. Let's not waste that training and expertise. We can work together to create a more inclusive and equitable research landscape and stamp out the exclusion of people with learning disabilities from clinical research. 

• Peter E. Langdon, CPsychol, FBPsS; Intellectual Disabilities Research Institute (IDRIS), University of Birmingham, Birmingham Community Healthcare NHS Foundation Trust, and Herefordshire and Worcestershire Health and Care NHS Trust
• Biza Stenfert Kroese, CPsychol, AFBPsS; School of Psychology, University of Birmingham
• Glynis H. Murphy, CPsychol, FBPsS; Tizard Centre, University of Kent
• Gemma Unwin, School of Psychology, University of Birmingham
• John Rose, CPsychol, FBPsS; School of Psychology, University of Birmingham
• Olivia Hewitt, Intellectual Disabilities Research Institute (IDRIS), University of Birmingham and Berkshire Healthcare NHS Foundation Trust
• Vivien Cooper, Challenging Behaviour Foundation, Kent

Main photo above courtesy of Learning Disability England

References

Cooper, S. A., Smiley, E., Allan, L. M., Jackson, A., Finlayson, J., Mantry, D., & Morrison, J. (2009a). Adults with intellectual disabilities: prevalence, incidence and remission of self-injurious behaviour, and related factors. J Intellect Disabil Res, 53(3), 200-216. 

Cooper, S. A., Smiley, E., Jackson, A., Finlayson, J., Allan, L., Mantry, D., & Morrison, J. (2009b). Adults with intellectual disabilities: prevalence, incidence and remission of aggressive behaviour and related factors. Journal of Intellectual Disability Research, 53, 217-232. 

Cooper, S. A., Smiley, E., Morrison, J., Allan, L., & Williamson, A. (2007a). Prevalence of and association with mental ill health in adults with intellectual disabilities. British Journal of Psychiatry, 190, 27-35. 

Cooper, S. A., Smiley, E., Morrison, J., Williamson, A., & Allan, L. (2007b). Mental ill-health in adults with intellectual disabilities: prevalence and associated factors. Br J Psychiatry, 190, 27-35. 

Department of Health and Social Care. (2023). The NHS Constitution for England.

Feldman, M. A., Bosett, J., Collet, C., & Burnham-Riosa, P. (2014). Where are persons with intellectual disabilities in medical research? A survey of published clinical trials. J Intellect Disabil Res, 58(9), 800-809. 

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House, A., Bryant, L., Russell, A. M., Wright-Hughes, A., Graham, L., Walwyn, R., Wright, J. M., Hulme, C., O'Dwyer, J. L., Latchford, G., Meer, S., Birtwistle, J. C., Stansfield, A., Ajjan, R., & Farrin, A. (2018). Managing with Learning Disability and Diabetes: OK-Diabetes - a case-finding study and feasibility randomised controlled trial. Health Technol Assess, 22(26), 1-328. 

Koslowski, N., Klein, K., Arnold, K., Kösters, M., Schützwohl, M., Salize, H. J., & Puschner, B. (2016). Effectiveness of interventions for adults with mild to moderate intellectual disabilities and mental health problems: systematic review and meta-analysis. The British Journal of Psychiatry, bjp. bp. 114.162313. 

McDonald, K. E., Schwartz, A. E., & Sabatello, M. (2022). Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in? Disabil Health J, 15(4), 101368. 

Morgan, V. A., Leonard, H., Bourke, J., & Jablensky, A. (2008). Intellectual disability co-occurring with schizophrenia and other psychiatric illness: population-based study. British Journal of Psychiatry, 193(5), 364-372. 

Mulhall, P., Taggart, L., Coates, V., McAloon, T., & Hassiotis, A. (2018). A systematic review of the methodological and practical challenges of undertaking randomised-controlled trials with cognitive disability populations. Soc Sci Med, 200, 114-128. 

Rojahn, J., & Meier, L. J. (2009). Epidemiology of mental illness and maladaptive behavior in intellectual disabilities. International Review of Research in Mental Retardation, 38, 239-287. 

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