Randomised control trial of a digitally provided psychological intervention for people who have a gene for frontotemporal dementia or Alzheimer's disease in their family

Improving Wellbeing Associated with Rare Familial dementias (IWARF): an online support programme to improve psychological outcomes in people living at risk of inheriting either familial frontotemporal dementia or familial Alzheimer's disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16524074

Enrollment

118

Registered

2024-09-12

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial dementias and specifically familial Fronto-Temporal Dementia (fFDT) and Familial Alzheimer's Disease (FAD) Nervous System Diseases

Interventions

The aim of this study is to test the effectiveness of an online support programme (IWARF) via a randomised controlled trial (RCT) to improve a range of psychological outcomes for people living at risk

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18+ years with a first-degree relative who is symptomatic and/or a known mutation carrier for an inheritable form of dementia (either familial Alzheimer’s disease [FAD] or familial Fronto-Temporal Dementia [fFTD]) 2. Capacity to consent to research 3. Access to an internet-enabled device

Exclusion criteria

Exclusion criteria: 1. Individual is below the age of 18 years 2. Individual does not have a first-degree relative who is symptomatic and/or a known mutation carrier 3. Individual reports to the trial team to be displaying symptoms of FAD/fFTD before enrollment 4. Individual does not have capacity to consent to research 5. Individual does not have access to an internet-enabled device

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 07/11/2025: Overall mental wellbeing assessed using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at T0 (baseline), T1 (~9 weeks after baseline), and T2 (follow-up at 6 months after baseline) Previous primary outcome measure: Overall mental wellbeing assessed using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at T0 (baseline), T1 (~8 weeks after baseline), and T2 (follow-up at 6 months after baseline)	—

Measure

Time frame

Current primary outcome measure as of 07/11/2025: Overall mental wellbeing assessed using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at T0 (baseline), T1 (~9 weeks after baseline), and T2 (follow-up at 6 months after baseline) Previous primary outcome measure: Overall mental wellbeing assessed using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at T0 (baseline), T1 (~8 weeks after baseline), and T2 (follow-up at 6 months after baseline)

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Secondary

Measure	Time frame
Measured at T0, T1 and T2: 1. Anxiety measured using the General Anxiety Disorder 7-item scale (GAD7) 2. Depression measured using the Patient Health Questionnaire 9-item scale (PHQ9) 3. Feelings related to genetic risk/predictive testing measured using an adapted version of the 26-item Psychological Adaptation to Genetic Information Scale (PAGIS) 4. Health-related quality of life measured using the European Quality of Life 5 Dimensions 5 level version (EQ-5D-5L) 5. Quality of life and capability wellbeing measured using the ICEpop CAPability for Adults 5-item scale (ICECAP-A) 6. Loneliness measured using the Office for National Statistics loneliness measure comprised of the UCL 3-item loneliness measure with additional subjective loneliness question 7. Acceptance and Commitment Therapy (ACT) based skills, and primarily psychological flexibility measured using the 24-item Multidimensional Psychological Flexibility Inventory (MPFI-24) 8. Health and social care resource use measured using a bespoke health economics measure, AR-RUM, developed for the purposes of the trial 9. The usability of the website will be evaluated using the System Usability Scale ?(SUS) at T1 only and only in the intervention group (it forms part of the process evaluation)	—

Measure

Time frame

Measured at T0, T1 and T2: 1. Anxiety measured using the General Anxiety Disorder 7-item scale (GAD7) 2. Depression measured using the Patient Health Questionnaire 9-item scale (PHQ9) 3. Feelings related to genetic risk/predictive testing measured using an adapted version of the 26-item Psychological Adaptation to Genetic Information Scale (PAGIS) 4. Health-related quality of life measured using the European Quality of Life 5 Dimensions 5 level version (EQ-5D-5L) 5. Quality of life and capability wellbeing measured using the ICEpop CAPability for Adults 5-item scale (ICECAP-A) 6. Loneliness measured using the Office for National Statistics loneliness measure comprised of the UCL 3-item loneliness measure with additional subjective loneliness question 7. Acceptance and Commitment Therapy (ACT) based skills, and primarily psychological flexibility measured using the 24-item Multidimensional Psychological Flexibility Inventory (MPFI-24) 8. Health and social care resource use measured using a bespoke health economics measure, AR-RUM, developed for the purposes of the trial 9. The usability of the website will be evaluated using the System Usability Scale ?(SUS) at T1 only and only in the intervention group (it forms part of the process evaluation)

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Countries

England, United Kingdom, Wales

Contacts

Public ContactJoshua Stott

j.stott@ucl.ac.uk+44 (0)207 679 5950

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026