Guided self-help for anxiety among Huntington’s disease gene expansion carriers (GUIDE-HD) compared to treatment as usual:a randomised controlled feasibility trial

Dale, Maria and Eccles, Fiona and Melvin, Katie and Khan, Zaynah and Jones, Lee and Zarotti, Nicolò and Kiani, Reza and Johnson, Jenny and Wells, Robert and Simpson, Jane (2023) Guided self-help for anxiety among Huntington’s disease gene expansion carriers (GUIDE-HD) compared to treatment as usual:a randomised controlled feasibility trial. Pilot and Feasibility Studies. ISSN 2055-5784 (In Press)

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Abstract

Background: Huntington’s disease (HD) is an adult-onset genetic neurodegenerative condition, involving cognitive decline, motor impairments and emotional difficulties. Anxiety affects up to 71% of HD gene expansion carriers (i.e., those with the version of the gene that causes HD) and can negatively affect quality of life, worsen other HD symptoms, and increase suicide risk. Therefore, helping people with their anxiety should be a clinical priority. A significant evidence base now exists for low-cost talking therapies for anxiety, such as guided self-help, and with people with other neurodegenerative diseases (e.g., Parkinson’s disease). However, this type of intervention has not been specifically assessed for HD gene expansion carriers. Methods: This protocol describes an exploratory randomised controlled feasibility study of a psychological intervention for anxiety. The 10 session guided self-help intervention is based on a blend of second and third wave cognitive behavioural models of anxiety (cognitive behaviour therapy [CBT] and acceptance and commitment therapy [ACT]) and is adapted to meet the specific needs of an HD population. This study will compare guided self-help with treatment as usual (TAU), with 15 HD gene expansion carriers randomly allocated to each group. Participants will be recruited across the East Midlands region in the UK. Quantitative data will be collected pre intervention, immediately post intervention, three-month post intervention and six-month post intervention; qualitative data will be collected at one month post intervention from participants including HD carers. The data will be analysed to assess whether the current intervention and study design is feasible to progress to a larger randomised controlled trial. Feasibility has been defined in terms of recruitment rate, retention rate to both trial arms, intervention adherence, and acceptability of the intervention and measurement tools. Discussion Given the lack of evidenced interventions to date to support the wellbeing of people with the expanded Huntington’s gene, this study will assess the feasibility of progressing this particular intervention to a full trial. To try and increase the acceptability of the intervention, a number of stakeholders, including those affected by HD and in caring roles, have been fundamental to the creation of the intervention (e.g., therapy manual, planned therapy process) to date.