A clinical trial of internet-delivered acceptance and commitment therapy for family carers of people with dementia
| ISRCTN | ISRCTN45995725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45995725 |
| IRAS number | 324157 |
| Secondary identifying numbers | CPMS 55321, IRAS 324157 |
- Submission date
- 11/04/2023
- Registration date
- 12/04/2023
- Last edited
- 16/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Family carers are at higher risk of anxiety and depression. Offering treatments online improves availability for people who have mobility problems, live remotely or cannot leave home. This makes it more accessible to everyone and easier to provide, so could be rolled out nationally, reducing inequalities in access to care.
This large study aims to find out if internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS) is helpful in reducing anxiety and affordable; and how iACT4CARERS can be successfully delivered to diverse carer populations and in different healthcare settings.
Who can participate?
Family carers may be eligible if they are aged 18 years or over and currently providing support to a family member living with dementia. The criteria for participating in the study include a family carer who is presenting with anxiety symptoms and be willing to receive online support for this. They also need to have access to a tablet, computer, or smartphone and have internet access.
What does the study involve?
We will recruit 496 family carers presenting with anxiety symptoms, as that is the number we need to be sure that iACT4CARERS is adequately tested. Recruitment will target community groups, GPs and NHS mental health services with a specific focus on underrepresented people from ethnic minority groups. A computer allocates half the people to iACT4CARERS intervention and half to the control group (standard care). People in the iACT4CARERS group will be asked to complete the intervention at their own pace with feedback from the therapist for each completed session. Participants in both groups will be asked to complete questionnaires assessing anxiety, depression and other relevant outcomes before and after the intervention and 3 months after that. The researchers will also interview participants, therapists and clinicians involved in recruitment to gain in-depth insights into their views on the intervention and its implementation.
What are the possible benefits and risks of participating?
There may be no direct benefit to participants if they are not allocated to receive iACT4CARERS. If participants are allocated to receive iACT4CARERS, they may see some improvements in their mood after completing the online programme. It is hope that this study will help us find out if iACT4CARERS works and should be widely rolled out in healthcare (NHS) services. Some people may experience some upsetting feelings during online sessions. If this happens during the study and participants feel that they can no longer commit themselves to the process, they can withdraw from the study at any time without giving a reason.
Where is the study run from?
The University of East Anglia with support from the Norwich Clinical Trials Unit (CTU) (UK)
When is the study starting and how long is it expected to run for?
February 2021 to February 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Associate Professor Naoko Kishita, n.kishita@uea.ac.uk
Contact information
Principal Investigator
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
 ORCID ID |
0000-0001-8453-2714 |
|---|---|
| N.Kishita@uea.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The clinical and cost-effectiveness of internet-delivered self-help acceptance and commitment therapy for family carers of people with dementia (iACT4CARERS): a randomized controlled trial with ethnically diverse family carers |
| Study acronym | iACT4CARERS |
| Study hypothesis | Primary hypothesis: 1. iACT4CARERS plus treatment-as-usual (TAU) will be superior to TAU alone in improving anxiety symptoms in family carers of people with dementia at 12 weeks post-randomisation Secondary hypotheses: 1. iACT4CARERS plus TAU will be superior to TAU alone in improving anxiety symptoms over a 24-week follow-up period 2. iACT4CARERS plus TAU will be superior to TAU alone in improving other mental health outcomes (e.g. psychological flexibility, depression) over 12-week and 24-week follow-up periods 3. iACT4CARERS plus TAU will be superior to TAU alone in terms of cost-effectiveness (cost per QALY) |
| Ethics approval(s) | Approved 05/04/2023, London - Queen Square Research Ethics Committee (HRA NRES Centre Bristol, 3rd floor, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048225; queensquare.rec@hra.nhs.uk), ref: 23/LO/0188 |
| Condition | Family carers of people with dementia |
| Intervention | Potential participants will be recruited through various methods including self-referrals responding to study advertisements and referrals from Participant Identification Centres and participating trial sites. In all cases, all potential participants will be first referred to the University of East Anglia. STEP 1: Initial contact Upon receipt of referrals, the research team member based at the University of East Anglia (UEA) will describe the study to potential participants and send an information pack consisting of an information sheet, eligibility checklist and consent form via email if they express an interest. The information pack can also be sent via post if preferred. The research team member will give a follow-up phone call to see if they have any questions. STEP 2: Informed consent and screening assessment (50 minutes) Participants who opt to take part in the study will be asked to attend the screening session via telephone or video call. At the beginning of the session, potential participants will be asked to provide fully informed written consent electronically. Once online written consent has been obtained, participants will be asked to complete the online screening assessment. The screening assessment includes an eligibility checklist (a series of statements asking that they meet the eligibility criteria), demographic questions and the measure of anxiety (Generalised Anxiety Scale; GAD7). Participants meeting eligibility criteria and scoring five or above on the GAD7 will be asked to continue completing all baseline measures online. If the postal information pack option is selected, participants will be asked to return the signed consent form and the completed eligibility checklist, the GAD7, socio-demographic questions and baseline measures using a prepaid envelope. STEP 3: iACT4CARERS intervention (40-60 minutes x 8 sessions) Eligible participants will be randomised to iACT4CARERS plus treatment as usual (TAU) or TAU alone. Participants randomised to iACT4CARERS plus TAU will receive a link to the iACT4CARERS website and login details via email (and post if requested). Unauthorised access to the intervention will be prevented by providing participants with unique login details. Participants will be instructed to complete eight online sessions within 12 weeks from this. Each session has three phases: self-learning, reflection and practice. The self-learning phase will guide carers through core Acceptance and Commitment Therapy (ACT) skills. Interactive exercises to illustrate ACT skills will be presented using multiple modes (video/audio/text). The reflection phase encourages participants to reflect on exercises, which they found helpful and ask questions. Individually tailored written feedback will be provided by a trial therapist via the online programme to encourage continued practice each week. The practice phase allows participants to set a goal and practice ACT skills offline between online sessions. Participants will be offered two brief (30-minute) one-to-one sessions with a therapist via telephone or video call in addition to the online programme (iACT4CARERS). These one-to-one sessions will be provided at the beginning and middle of the intervention. STEP 4: 12-week and 24-week follow-ups (50 minutes each) At 12 and 24 weeks after randomisation, participants will receive an email asking them to complete the follow-up measure online. The email will include a reminder, which reiterates the reasons why this follow-up data is important. If the follow-up measure is not completed within a week, the research team member based at the University of East Anglia will give a follow-up phone call to check if the participant needs additional support for completing the online assessments. Participants, who have indicated that they wish to receive the follow-up measure via post, will receive the follow-up assessments via post and will be asked to return them using a prepaid envelope. Purposely sampled participants will be invited to an individual interview at a 12-week follow-up as part of the process evaluation. The interview part is optional, and participants will receive a separate Participant Information Sheet (PIS) and consent form for this part of the study if invited. All interviews will be audio-recorded with their permission. Handwritten field notes will also be used to record additional comments and observations during the session. The research team member (interviewer) will use a blended approach during the interview, which consists of passive interviewing (allowing the participant space and time to share their narrative) and more active approaches by using questions and prompts listed in the interview guide. Trial therapists and referrers will also be invited to individual interviews separately. |
| Intervention type | Behavioural |
| Primary outcome measure | Anxiety is measured using the General Anxiety Disorder-7 (GAD7) at baseline and 12- and 24-week post-randomisation |
| Secondary outcome measures | 1. Depression is measured using the Patient Health Questionnaire-9 (PHQ9) at baseline and 12- and 24-week post-randomisation 2. Psychological flexibility is measured using the Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT) and the Experiential Avoidance in Caregiving Questionnaire (EACQ) at baseline and 12- and 24-week post-randomisation 3. Quality of life is measured using the Health-related quality of life (EQ-5D-5L) and the ICEpop CAPability measure for Older people (ICECAP-O) at baseline and 12- and 24-week post-randomisation 4. Health and social care service utilisation is assessed using the Modified Client Service Receipt Inventory (modified CSRI) at baseline and 12- and 24-week post-randomisation 5. Satisfaction with therapy is measured using the Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) at 12-week post-randomisation (only applicable to the intervention group) |
| Overall study start date | 01/02/2021 |
| Overall study end date | 01/02/2026 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 496; UK Sample Size: 496 |
| Participant inclusion criteria | 1. Aged 18 years and over 2. Caring for a family member diagnosed with dementia 3. Presenting anxiety symptoms (this will be assessed using a standardised measure GAD7 at screening) 4. Help-seeking (carers who want to receive online support) 5. Having access to the internet |
| Participant exclusion criteria | 1. Lacking the capacity to provide fully informed written consent 2. Currently receiving ongoing formal psychological therapy (e.g. CBT, psychodynamic psychotherapy, systemic therapy and counselling) 3. Experiencing disabling medical or mental health problems making participation inappropriate or impractical 4. Expressing active suicidal intent |
| Recruitment start date | 25/10/2023 |
| Recruitment end date | 01/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Drayton High Road
Norwich
NR6 5BE
United Kingdom
Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom
Beaconsfield Road
Hatfield
AL10 8YE
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
1st Floor
Maggie Lilley Suite
Barley Lane
Ilford
IG3 8XJ
United Kingdom
Wilson Way
Pool
Redruth
TR15 3QE
United Kingdom
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Botley Road
West End
Southampton
SO30 3JB
United Kingdom
11 Shelley Road
Boscombe
Bournemouth
BH1 4JQ
United Kingdom
15 Springfield Drive
London
SW17 0YF
United Kingdom
Kettering
NN15 7PW
United Kingdom
Kingsway
Derby
DE22 3LZ
United Kingdom
Guildford Street
Chertsey
KT16 9AU
United Kingdom
Room 311, Block 9
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Downs Way
The Great Western Site
Swindon
SN3 6BW
United Kingdom
Headington
Oxford
OX3 7JX
United Kingdom
London
SE5 8AZ
United Kingdom
Balby
Doncaster
DN4 8QN
United Kingdom
Earley Gate
Whiteknights Road
Berkshire
RG6 7BE
United Kingdom
Vicarage Lane
Fulwood
Preston
PR2 8DW
United Kingdom
Sponsor information
University/education
Norwich Research Park
Earlham Road
Norwich
NR4 7TJ
England
United Kingdom
| researchsponsor@uea.ac.uk | |
| Website | https://www.uea.ac.uk/ |
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No | ||
| Protocol file | version 1.0 | 21/12/2022 | 01/08/2024 | No | No |
| Protocol article | 12/09/2024 | 16/09/2024 | Yes | No |
Additional files
Editorial Notes
16/09/2024: Publication reference added.
01/08/2024: Protocol uploaded.
26/10/2023: The recruitment start date was changed from 01/11/2023 to 25/10/2023.
20/09/2023: A link to the HRA research summary was added.
25/08/2023: The study participating centre Lancashire and South Cumbria NHS Foundation Trust was added.
26/07/2023: The study participating centre Imperial College Healthcare NHS Trust was removed.
13/04/2023: Internal review.
12/04/2023: Trial's existence confirmed by the NIHR.
