GUIDE-HD v.1.0
Research type
Research Study
Full title
Guided self-help for anxiety among Huntington’s disease gene expansion carriers compared to treatment as usual: a randomised controlled feasibility trial (GUIDE-HD).
IRAS ID
304674
Contact name
Maria Dale
Contact email
Sponsor organisation
Leicestershire Partnership NHS Trust
ISRCTN Number
ISRCTN47330596
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
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 and damages quality of life, worsens other HD symptoms and increases suicide risk. Therefore, helping people with their anxiety is a priority. Despite the evidence-base for low-cost talking therapies for anxiety, such as guided self-help, this has not been specifically applied to HD gene expansion carriers. Guided self-help has shown promise in other neurodegenerative diseases (e.g. Parkinson’s disease). Therefore, a similar approach may benefit HD gene expansion carriers.Aim:
To determine whether it is feasible to undertake a randomised controlled trial to assess the use of guided self-help aimed at decreasing anxiety among Huntington's disease gene expansion carriers, compared to treatment as usual.Methods:
The proposed study is an exploratory randomised controlled feasibility trial of a psychological intervention for anxiety. This study will compare guided self-help (GSH) with Treatment as usual (TAU), with 15 HD gene expansion carriers in each group. HD participants can have a carer/family member to support them with the intervention, but this is not a requirement of the study. Participants will be recruited across the Est Midlands region. Data gathered will be used to assess whether the current intervention and study design meets pre-determined criteria that would indicate progression to a larger randomised controlled trial . The 10 week intervention is based on cognitive behavioural models of anxiety and is adapted to meet the specific needs of an HD population. HD participants and carers will be invited for interview within 1 month post-intervention and this data will be analysed qualitatively.Sharing results:
Results will be published and presented at international conferences. Information will also be distributed more widely to the HD community.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0092
Date of REC Opinion
15 Jun 2022
REC opinion
Further Information Favourable Opinion