Mental Health Wellness 1PROSPECTNCT04099095
A Mental Health Social Prescribing Trial (British Red Cross)
A study testing Immediate Appointment and Delayed Appointment in people with Mental Health Wellness 1, run by University of South Wales at 1 site in United Kingdom.
Trial summary
Social prescribing is a way of understanding the things that are important to a person and then using these to find groups and resources in their local community that can help them meet their goals and understand their problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Immediate Appointment and Delayed Appointment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care service users who are at the point of referral
- Experiencing mild/moderate mental health and/or emotional wellbeing disorders( eg anxiety or depression)
- Aged 18+ years
- Registered with a General Practitioner in Wales
Who cannot join
- Unable to give written informed consent
- Unable to answer all questions (WEMWBS) at baseline
- Worsening of mental health condition to the point where more intensive support is required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPECT: A Mental Health Social Prescribing Trial (British Red Cross)
Social prescribing is a way of understanding the things that are important to a person and then using these to find groups and resources in their local community that can help them meet their goals and understand their problems. Social prescribing can be used with people who have physical health problems, mental health problems, social problems such as loneliness or financial/housing problems.
The Welsh Government has supported the creation of these social prescribing services across Wales. However, the evidence showing that social prescribing is a good way of improving a person's well-being and quality of life is not very strong.
Read more
This project is an evaluation of a new social prescribing service delivered by British Red Cross in two areas in Wales. British Red Cross have made a new social prescribing service, where a link worker works with a patient who has mild/moderate mental or emotional health problems, to understand their needs and set them goals for the future over 12 weeks of core support. The link worker will also help them find services in their local community that might help them achieve their goals.
The study uses a waitlist trial, thus some participants will get to meet the link worker and have the intervention straight away, while others will have to wait for 20 working days. From this, the researchers can compare the people who had the intervention straight away with the people who had to wait. Scores on well-being and quality of life questionnaires will be used to see the effects of the intervention on participants.
Read the detailed description
Social prescribing is an umbrella term to describe ways of linking people to sources of community-based, non-medical support. There is no fixed definition of social prescribing.
In Wales, social prescribing has many models which require the NHS and third sector organisations to work closely together. These involve referral to a link worker/community connector/social prescriber from primary care or another referral route, such as social work or housing. These roles all practice social prescribing, which includes a 'what matters' conversation, co-productive goal setting, motivational interviewing and coaching, followed by referral to third sector and community groups/professionals for support and activity to meet the person's individual goals.
Social prescribing is being widely implemented and has support from Welsh Government. However, there is limited research evidence to judge its effectiveness, who benefits (if at all) and its value for money. Public Health Wales identified gaps in the published evidence for social prescribing, particularly in the evaluation of social prescribing projects in primary care in Wales. It is therefore important to employ more rigorous and high-quality methods to evaluating social prescribing interventions in the community.
As part of a Welsh Government Third Sector grant for delivering a social prescribing pilot with a focus on mental health, British Red Cross are undertaking a research project in two localities in Wales, Caerphilly and Pembrokeshire, to create and test a model of social prescribing. As part of this initiative, a link worker will work with the individual over a 12-week period to discuss their needs, goals and future steps. A link worker helps the individual to explore extra services that may support them in improving their health, sense of wellness and independence by providing practical and emotional support.
This study will conduct an evaluation alongside the implementation and delivery of the British Red Cross social prescribing intervention, using a randomised waitlist evaluation method. Participants will either receive the social prescribing intervention within 5 days of giving consent, or 20 working days after consent and baseline data collection. This will allow the researchers to draw comparisons between the immediate intervention group and the waitlist controls, who continue to receive usual care. This will also provide a more robust evidence base for social prescribing interventions. The study will use measures of quality of life and wellbeing.
- Conditions
- Mental Health Wellness 1
- Being tested
- Immediate Appointment, Delayed Appointment
- Keywords
- Wait-list
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate AppointmentBehavioural
The participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant
Delayed AppointmentBehavioural
After a period of delay (control) the participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant
| Study group | Role | What they receive |
|---|---|---|
| Immediate Appointment | Active comparator | Intervention group who receive the Social Prescription without delay. The effectiveness of the consultation and referral process will be assessed Receives: Behavioral: Immediate Appointment |
| Delayed Appointment | Active comparator | Wait-list control group who receive Social Prescribing after a delay of 20 working days. The effectiveness of the consultation and referral process will be assessed Receives: Behavioral: Delayed Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from base-line. The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) Score
SWEMWBS is completed by the participants and allows self-reflection on mental well-being before and during involvement in health enhancing activities. Each of the 7 statement can be scored from 1 to 5, from 'none of the time' to 'all of the time'. A total score is calculated by summing the 7 individual statement scores. The minimum score is 7 and the maximum is 35. The higher score signifies better mental well-being.
Measured: At Base-line, 4 weeks and 3 months after randomisation
Change from base-line. EQ-5D-5L Health Questionnaire
The EQ-5D-5L Health questionnaire records the self-reported health using five sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each section receives a score ranging from 1 to 5, with a score of 5 providing the most ill-health. The minimum total score is 5 and the maximum 25. The lower the score the better the health of the participant. Part 2 of the questionnaire provides a self-reporting vertical visual analogue scale with the end points labelled, "The best health you can imagine" scoring 100 and "The worst health you can imagine", scoring 0.
Measured: At Base-line, 4 weeks and 3 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jan 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Why it stopped: COVID epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a randomised wait-list trial design with mixed methods using a co-productive participatory approach.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- British Red Cross
- Responsible party
- Sponsor
- Investigators
- Mark Llewellyn, Study director, University of South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099095
- Sponsor's protocol ID
- IRAS 261969
- Acronym
- PROSPECT
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECT: A Mental Health Social Prescribing Trial (British Red Cross)
- ClinicalTrials.gov ID
- NCT04099095
- Acronym / sponsor ID
- PROSPECT / IRAS 261969
- Conditions
- Mental Health Wellness 1
- Keywords
- Wait-list
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID epidemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Collaborators
- British Red Cross
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Social prescribing is a way of understanding the things that are important to a person and then using these to find groups and resources in their local community that can help them meet their goals and understand their problems. Social prescribing can be used with people who have physical health problems, mental health problems, social problems such as loneliness or financial/housing problems.
The Welsh Government has supported the creation of these social prescribing services across Wales. However, the evidence showing that social prescribing is a good way of improving a person's well-being and quality of life is not very strong.
This project is an evaluation of a new social prescribing service delivered by British Red Cross in two areas in Wales. British Red Cross have made a new social prescribing service, where a link worker works with a patient who has mild/moderate mental or emotional health problems, to understand their needs and set them goals for the future over 12 weeks of core support. The link worker will also help them find services in their local community that might help them achieve their goals.
The study uses a waitlist trial, thus some participants will get to meet the link worker and have the intervention straight away, while others will have to wait for 20 working days. From this, the researchers can compare the people who had the intervention straight away with the people who had to wait. Scores on well-being and quality of life questionnaires will be used to see the effects of the intervention on participants.
Detailed description
Social prescribing is an umbrella term to describe ways of linking people to sources of community-based, non-medical support. There is no fixed definition of social prescribing.
In Wales, social prescribing has many models which require the NHS and third sector organisations to work closely together. These involve referral to a link worker/community connector/social prescriber from primary care or another referral route, such as social work or housing. These roles all practice social prescribing, which includes a 'what matters' conversation, co-productive goal setting, motivational interviewing and coaching, followed by referral to third sector and community groups/professionals for support and activity to meet the person's individual goals.
Social prescribing is being widely implemented and has support from Welsh Government. However, there is limited research evidence to judge its effectiveness, who benefits (if at all) and its value for money. Public Health Wales identified gaps in the published evidence for social prescribing, particularly in the evaluation of social prescribing projects in primary care in Wales. It is therefore important to employ more rigorous and high-quality methods to evaluating social prescribing interventions in the community.
As part of a Welsh Government Third Sector grant for delivering a social prescribing pilot with a focus on mental health, British Red Cross are undertaking a research project in two localities in Wales, Caerphilly and Pembrokeshire, to create and test a model of social prescribing. As part of this initiative, a link worker will work with the individual over a 12-week period to discuss their needs, goals and future steps. A link worker helps the individual to explore extra services that may support them in improving their health, sense of wellness and independence by providing practical and emotional support.
This study will conduct an evaluation alongside the implementation and delivery of the British Red Cross social prescribing intervention, using a randomised waitlist evaluation method. Participants will either receive the social prescribing intervention within 5 days of giving consent, or 20 working days after consent and baseline data collection. This will allow the researchers to draw comparisons between the immediate intervention group and the waitlist controls, who continue to receive usual care. This will also provide a more robust evidence base for social prescribing interventions. The study will use measures of quality of life and wellbeing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a randomised wait-list trial design with mixed methods using a co-productive participatory approach.
| Arm | Type | Receives |
|---|---|---|
| Immediate Appointment | Active comparator | Behavioral: Immediate AppointmentIntervention group who receive the Social Prescription without delay. The effectiveness of the consultation and referral process will be assessed |
| Delayed Appointment | Active comparator | Behavioral: Delayed AppointmentWait-list control group who receive Social Prescribing after a delay of 20 working days. The effectiveness of the consultation and referral process will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary care service users who are at the point of referral
- Experiencing mild/moderate mental health and/or emotional wellbeing disorders( eg anxiety or depression)
- Aged 18+ years
- Registered with a General Practitioner in Wales
Key exclusion criteria (3 listed)
- Unable to give written informed consent
- Unable to answer all questions (WEMWBS) at baseline
- Worsening of mental health condition to the point where more intensive support is required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate AppointmentThe participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant | Behavioural | Immediate Appointment |
| Delayed AppointmentAfter a period of delay (control) the participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant | Behavioural | Delayed Appointment |
Primary outcome
Change from base-line. The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) Score
Time frame: At Base-line, 4 weeks and 3 months after randomisation
SWEMWBS is completed by the participants and allows self-reflection on mental well-being before and during involvement in health enhancing activities. Each of the 7 statement can be scored from 1 to 5, from 'none of the time' to 'all of the time'. A total score is calculated by summing the 7 individual statement scores. The minimum score is 7 and the maximum is 35. The higher score signifies better mental well-being.
Change from base-line. EQ-5D-5L Health Questionnaire
Time frame: At Base-line, 4 weeks and 3 months after randomisation
The EQ-5D-5L Health questionnaire records the self-reported health using five sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each section receives a score ranging from 1 to 5, with a score of 5 providing the most ill-health. The minimum total score is 5 and the maximum 25. The lower the score the better the health of the participant. Part 2 of the questionnaire provides a self-reporting vertical visual analogue scale with the end points labelled, "The best health you can imagine" scoring 100 and "The worst health you can imagine", scoring 0.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Llewellyn study director
University of South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Appointment and Delayed Appointment in people with Mental Health Wellness 1, run by University of South Wales at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from base-line. The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) Score (time frame: At Base-line, 4 weeks and 3 months after randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.