Anxiety among Huntington's disease gene expansion carriers Mental and Behavioural Disorders
Conditions
Interventions
The proposed study will collect both quantitative and qualitative data. The design is an exploratory randomised controlled feasibility trial of a psychological intervention for anxiety. This study wil
Sponsors
Leicestershire Partnership NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Huntington's Disease Participants: 1. Confirmed genetic test for HD (CAG >=36) 2. Diagnosed with clinical anxiety using Structured Clinical Interview for DSM-5 (SCID-5) 3. Premanifest or manifest HD 4. For those who are manifest HD, will be early-stage HD as defined as those with a United Huntington’s Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) score of 9-13 4. If taking a medication known to impact on anxiety, must be stabilised for 4 weeks 5. Able to read/understand English 6. Aged >=18 years 7. Able and willing to give informed consent HD Carers: 1. Aged >=18 years 2. Had some involvement in the intervention 3. Able to give informed consent
Exclusion criteria
Exclusion criteria: HD Participants: 1. Current suicidal intent 2. Significant cognitive or communication impairment as determined by MOCA and clinical psychologist opinion 3. Unstable medical conditions 4. Currently receiving another psychological intervention aimed at reducing anxiety 5. Acute psychosis or other acute psychiatric presentation requiring intense/urgent input from mental health professionals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed using: 1. Recruitment rate (% eligible participants who consent) by the end of the study 2. Retention of participants in both arms of the trial (% who remain in the study at 3- and 6-month follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Further feasibility outcomes: 1. Acceptability of the intervention assessed with Likert ratings 0-5 on dimensions of readability, clarity, effort, enjoyment, concentration, helpfulness, and progress regarding therapy materials at 2 weeks post-intervention, and qualitative interviews within 1 month post-intervention 2. Acceptability and suitability of outcome measures assessed with a Likert scale at 6 months, qualitative interviews and % willing to complete the measures at each timepoint (ie. baseline, within 2 weeks after the intervention, 3- and 6-month follow-ups) 3. Adherence to the intervention (% of activities accomplished) by the end of the study. The following measures will be used at baseline, within 2 weeks after the intervention, 3- and 6-month follow-ups to assess the acceptability of the measures: 1. Anxiety measured by Hospital Anxiety and Depression Scale (HADS)- Anxiety subscale and Hamilton Anxiety Rating Scale (HAM-A) 2. Depression measured using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) 3. Irritability measured using the Snaith Irritability Scale 4. Quality of life measured using Huntington's Disease health-related Quality of Life questionnaire (HDQoL) 5. Functional ability measured using Unified Huntington's Disease Rating Scale Total Functional Capacity scale (UHDRS TFC) 6. Therapy process/mechanism measures: HD Concerns Questionnaire, Brief COPE, Acceptance and Action Questionnaire-II | — |
Countries
England, United Kingdom
Outcome results
None listed