Views and experiences of ethnic minority family carers on internet-delivered guided self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS)
| ISRCTN | ISRCTN15520542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15520542 |
| Secondary identifying numbers | CPMS 53137, NIHR150071, IRAS 316137 |
- Submission date
- 18/08/2022
- Registration date
- 19/08/2022
- Last edited
- 26/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Family carers of people with dementia are at higher risk of anxiety, but they currently have limited access to psychological services due to various barriers. Offering psychological 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.
We conducted a first study to explore if we could deliver Acceptance and Commitment Therapy (ACT) for family carers of people with dementia online within GPs and NHS mental health services, and family carer views of it (acceptability). This initial study was successful and more than 100 potential participants were referred to the study in just six months. Thirty-three eligible participants received online ACT, more than originally planned. We now need a larger trial involving enough carers to establish whether online ACT can reduce carer anxiety and is affordable and whether it should be widely rolled out in the NHS.
The first step in preparing for the next large trial will be to investigate the acceptability of online ACT among family carers from ethnic minority groups as we did not fully explore the views of this population in our first study. Family carers from ethnic minority groups currently have the least access to formal support services. Ensuring that online ACT is acceptable and accessible to culturally diverse family carers will be critical for a successful wider rollout.
Who can participate?
Family carers of people with dementia from ethnic minority groups
What does the study involve?
Carers will be asked to complete eight online sessions on a self-learning basis with weekly feedback from their therapist. Individual interviews will be conducted with carers and therapists to assess the acceptability and identify areas for further improvement.
What are the possible benefits and risks of participating?
By completing the online programme, participants may see some improvements in their mood and/or the number of activities that they do each day. Some participants may find it upsetting to reflect on their distressing thoughts and feelings during online therapy sessions. Participants can withdraw from the study at any time without giving a reason.
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
June 2022 to November 2023
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK).
Who is the main contact?
Dr Naoko Kishita, N.Kishita@uea.ac.uk
Contact information
Scientific
School of Health Sciences
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 | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| 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 | Views and experiences of ethnic minority family carers on internet-delivered guided self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): A qualitative study |
| Study acronym | iACT4CARERS |
| Study objectives | This study aims to pilot the refined version of iACT4CARERS (internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia), which incorporates additional one-to-one sessions via telephone or video call, among family carers of people with dementia from ethnic minority groups. Research questions: 1. What are the perceptions and experiences of iACT4CARERS, with a particular focus on newly introduced additional one-to-one sessions, among family carers of people with dementia from ethnic minority groups? 2. What are the perceptions and experiences of iACT4CARERS, with a particular focus on newly introduced additional one-to-one sessions, among therapists? |
| Ethics approval(s) | Approved 16/08/2022, NHS London - Queens Square Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 2071048225; queensquare.rec@hra.nhs.uk), ref: 22/PR/0743 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Once written consent has been obtained, potential participants will be asked to complete self-reported measures using an online or postal survey pack. These will include a demographic questionnaire, the Generalized Anxiety Disorder-7 (GAD7) and the Patient Health Questionnaire-9 (PHQ9). These variables will be used to characterise the sample. The risk of suicide will also be assessed by the trained researcher (i.e. Chief Investigator, research associates) during the initial assessment session. Eligible participants will receive a link to the iACT4CARERS website and login details immediately after the initial assessment session 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. 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 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 (20-30 minutes) 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. After the completion of iACT4CARERS, participants will be asked to attend an individual interview session via telephone or video call. Interviews will examine attitudes towards one-to-one sessions, suitability of their content, any impact they had on engagement with iACT4CARERS and any suggestions for improvement. First, participants will be asked to complete the Satisfaction with Therapy and Therapist Scale-Revised, either electronically or via post. Following this, the researcher will conduct the individual interview. The volume and quality of the audio recording will be checked at this point to ensure a clear recording. All interviews will be audio-recorded with the participant’s permission. Handwritten field notes will also be used to record additional comments and observations during the session. The researcher 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 (attached to this ethics application). To end the interview, the researcher will allow a final opportunity for the participant to add or expand upon anything else that may have not yet been discussed. Closing remarks will be made, whereafter the interview will be concluded. All therapists will also be invited to an individual interview to provide feedback |
| Intervention type | Behavioural |
| Primary outcome measure | Themes identified from transcripts of interviews conducted after completion of the intervention that identify views and experiences of family carers from ethnic minority groups and trial therapists on iACT4CARERS. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2022 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 10; UK Sample Size: 10 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Identifying oneself as a carer from ethnic minority groups 3. Caring for a family member diagnosed with dementia 4. Willing to complete iACT4CARERS 5. Having access to the internet Purposeful sampling will be used to recruit ten family carers of people with dementia from ethnic minority groups. Ethnic minorities refer to all ethnic groups except the white British group. A recent study on the dementia diagnosis in UK primary care demonstrated that dementia patients from the Asian ethnic group were the second largest group followed by the white British patient group. Therefore, we aim to recruit at least five family carers from the Asian ethnic group. |
| Key exclusion criteria | 1. Lacking capacity to provide fully informed written consent. 2. Experiencing disabling medical or mental health problems making participation inappropriate or impractical. 3. Expressing active suicidal intent. |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Norwich
NR6 5BE
United Kingdom
Beaconsfield Close
Hatfield
AL10 8YE
United Kingdom
Cambridge
CB21 5EF
United Kingdom
Sponsor information
University/education
Norwich Research Park
Earlham Road
Norwich
NR4 7TJ
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)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study results will be disseminated via abstract submission at national and international conferences and publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the data being qualitative, and not having relevant consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No | ||
| Results article | 26/03/2024 | 26/03/2024 | Yes | No |
Editorial Notes
26/03/2024: Publication reference added.
02/11/2023: The contact confirmed the record is up to date.
20/09/2023: A link to the HRA research summary was added.
31/01/2023: The recruitment end date was changed from 28/02/2023 to 31/01/2023. Total final enrolment added.
18/08/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
