Champions for health: a web-based acceptance and commitment therapy (ACT) intervention to enhance emotional wellbeing and encourage engagement with lifestyle behavioral changes
| ISRCTN | ISRCTN18190978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18190978 |
| Secondary identifying numbers | HCRW: SCS-14-11 |
- Submission date
- 24/01/2020
- Registration date
- 14/02/2020
- Last edited
- 04/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Globally prevalence rates of common mental disorder (CMD) such as anxiety and depression are high. In the UK estimated population incidence rates are between 4-10%. The individual and economic cost is significant. In the UK, the estimated costs of mental health problems are £70-100 billion each year and account for 4.5% of GDP. Thus prevention and early intervention make economic sense.
In contrast, positive mental health and wellbeing are associated with benefits across health, social and economic domains. WHO report the following benefits: improved overall functioning, better lifestyle choices, greater educational attainment, higher income and higher productivity. Positive wellbeing has been proposed as a protective factor which may contribute to positive physical health and associated reductions in mortality. For example, one study found positive wellbeing to be associated with reductions in cardiovascular mortality in a healthy population. Thus interventions focused on improving physical health and wellbeing could promote positive aspects of health and lead to numerous health benefits at a population level.
Barriers to access
Patient and public access to psychological treatments to treat CMDs is often limited by long waiting lists, inadequate numbers of trained professionals able to meet the high demand for face-to-face therapies and social stigma attached to mental health in general. The experience of social stigma causes many not to initiate or continue effective treatment. Web-based interventions do not require users to identify themselves, the anonymity afforded through these platforms may encourage higher rates of personal disclosure and thus could be therapeutically beneficial.
Web-based context
As a result internet and web-based interventions provide a cost-effective means by which to deliver health promotion and wellbeing interventions.
Study aim
Thus the current study aims to conduct a cluster randomized control trial (RCT) to evaluate the impact of an acceptance and commitment therapy (ACT) based emotional wellbeing intervention on; lifestyle behaviour change; adherence and engagement with lifestyle behaviour change modules and emotional wellbeing.
Who can participate?
Members of staff at recruited organizations who are able to access the website
What does the study involve?
This evaluation will be achieved by inviting staff at selected organizations to take part in a 12-week staff health challenge. Participants will be able to take part by signing up to a website called Champions for Health. They will have the opportunity to choose a health challenge to take part in that is suited to their health needs and will be randomized to receive access to the emotional wellbeing intervention or not.
What are the possible benefits and risks of participating?
It is anticipated that participation in the study could bring benefits at individual level in regards to improved physical health through the adoption of positive lifestyle behaviour change. In addition to this it is anticipated that positive benefits will be seen to those randomised to receive the wellbeing intervention who engage with it for the 12 week duration.
There are no anticipated risks to participants who consent to take part in this study.
Where is the study run from?
Swansea University (UK)
When is the study starting and how long is it expected to run for?
September 2019 to September 2020
Who is funding the study?
Health and Care Research Wales (UK)
Who is the main contact?
Mrs Menna Brown, menna.brown@swansea.ac.uk
Contact information
Scientific
Swansea Univerity
Singleton Park Campus
Data Science Building
Floor 3
Swansea
SA2 8PP
United Kingdom
 ORCID ID |
0000-0003-1427-1648 |
|---|---|
| Phone | +44 (0)1792606312 |
| menna.brown@swansea.ac.uk |
Study information
| Study design | A cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format please use contact details to request a participant information sheet |
| Scientific title | Champions for health: a randomized controlled trial of a web-delivered acceptance and commitment therapy (ACT) intervention to enhance subjective wellbeing and encourage engagement with lifestyle behavioral changes. |
| Study objectives | The use of an ACT-based, web-based intervention designed to promote emotional wellbeing will positively impact on health outcomes and engagement with lifestyle health behaviour change modules |
| Ethics approval(s) | 1. Approved 02/09/2019, Swansea University Medical School research ethics committee (Swansea University Medical School, Singleton Park, Swansea, SA2 8PP; d.gonzalez@swansea.ac.uk; +44 (0)1792 295384), ref: 2019-0056 2. Approved 06/01/2017, Swansea Bay University Health Board, Research and Development Joint Study Review Committee (JSRC) (One Talbot Gateway, Baglan Energy Park, Port Talbot, SA12 7BR; Sandra.Husbands@wales.nhs.uk; +44 01639 683334) |
| Health condition(s) or problem(s) studied | Emotional wellbeing and lifestyle behaviour change |
| Intervention | Participants are required to register on the study website, provide consent and complete a study registration form with baseline health and wellbeing questionnaires. They will then be automatically allocated to either the control or intervention arms based on the information they provide about their employing organization and site location within the organization. Participants are randomized at a cluster level, with each different site within the SBUHB health board (at which participants are employed) randomly allocated to either the intervention or the control arm. The researcher is blinded to this allocation. The website programmer used a randomly generated sequence to pre-program the website to allocate participants accordingly. The intervention arm receives an emotional wellbeing intervention based on acceptance and commitment therapy (ACT). The intervention is available to participants via the Champions for Health website for 12 weeks and has been designed to be accessed on a weekly basis. However, participants will have access to all 12 weeks immediately and are free to navigate the resources as they wish. Each week contains an ACT skill to learn, practice exercises and an interactive motivational goal-setting tool. The control arm participants have no access to the wellbeing intervention. Both control and intervention participants will have access to five lifestyle behavior change modules via a health promotion website. The baseline health and wellbeing questionnaires are repeated for all participants at 12 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | Emotional wellbeing measured by the Warwick-Edinburgh mental wellbeing scale (WEMWBS) and the patient health questionnaire for depression and anxiety (PHQ4) at baseline and 12 weeks |
| Secondary outcome measures | Psychological inflexibility and experiential avoidance measured by the Acceptance and Action Questionnaire-Revised (AAQ-II) at baseline and 12 weeks |
| Overall study start date | 01/09/2019 |
| Completion date | 22/05/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Total: 800, Clusters: 4 |
| Total final enrolment | 175 |
| Key inclusion criteria | 1. Member of staff at recruited organizations 2. Ability to read and write in English 3. Consent to participation |
| Key exclusion criteria | Unable to access intervention due to lack of device or internet access |
| Date of first enrolment | 17/02/2020 |
| Date of final enrolment | 28/02/2020 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Data Science Building
Floor 3
Swansea
SA2 8PP
United Kingdom
Sponsor information
University/education
Singleton Park Campus
Swansea
SA2 8PP
Wales
United Kingdom
| Phone | +44 (0)1792 205678 |
|---|---|
| reis@swansea.ac.uk | |
| Website | https://www.swansea.ac.uk |
"ROR" |
https://ror.org/053fq8t95 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 21/12/2021: Dissemination via PhD thesis Previous publication and dissemination plan: Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Menna Brown via email on menna.brown@swansea.ac.uk. The raw data collected in the study without identifying data will inlclude, pre and post wellbeing scores (where completed), enrolment to modules and engagement with modules. This data will be available until completion of the PhD project it is linked to (which is anticipated in July 2021). It will be made available in an Excel spreadsheet. Consent from participants will be obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Intervention design | 30/11/2020 | 04/04/2023 | Yes | No |
Editorial Notes
04/04/2023: Publication reference added.
21/12/2021: The following changes were made to the trial record:
1. The trial website was added.
2. The publication and dissemination plan was updated.
11/03/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2020 to 22/05/2020.
2. The total final enrolment was added.
27/01/2020: Trial’s existence confirmed by Swansea University Medical School Research Ethics Committee.
