Mental Health Wellness 1SPRINGNCT04062903
Social Prescribing Improving Mental Health Study
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
This study aims to evaluate a new social prescribing service delivered by Mind Cymru in four communities in Wales. Mind Cymru 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… 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
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 31 Oct 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 (e.g. anxiety or depression)
- Aged 18+ years
- Registered with a General Practioner in Wales
Who cannot join
- Unable to give written, informed consent
- Unable to answer all questions (WEMWBS and EQ-5D) 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: A Mental Health Social Prescribing Trial (Mind Cymru)
This study aims to evaluate a new social prescribing service delivered by Mind Cymru in four communities in Wales. Mind Cymru 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. The link worker will then help them find a service in their local community that might help them achieve their goals.
The study uses a waitlist trial, which means that 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, quality of life and loneliness questionnaires will be used to see the effects of the intervention on patients, whilst information like patient attendance at the General Practioner surgery will be used to see if there is a difference in the patient's use of health services.
Read the detailed description
This trial will employ a randomised wait-list control design. The study has been co-designed with the research team at University of South Wales, Mind Cymru, the link workers and General Practioners working within the study sites.
The study will assess the effectiveness of services provided through making three sets of comparisons (based on a set of individual- and service-level outcomes over time - comparing between: - The four Local Mind sites (Merthyr and Valleys, Vale of Clwyd, Brecon and District, Ystradgynlais);
- Those who complete the intervention immediately, with those who are in the waitlist group;
- Those who fully complete the social prescribing intervention with those who do not complete or partially the full social prescription but receive care as usual (either because they do not attend or only partially attend); and Participants will be randomly allocated to receive the social prescribing link worker intervention either immediately, or after a waiting period of 20 working days. Participants will be recruited through consultations with healthcare professionals, either their General Practioner, a practice nurse or the Total Nurse Triage system within the doctors surgery. If the healthcare professional identifies that the prospective participant meets the eligibility criteria of the study (experiencing mild/moderate mental health and/or emotional wellbeing disorders, aged 18+ and registered with a General Practioners in Wales), they will provide the prospective participant with an information pack, and ask for permission to contact. If this permission is given they will be subsequently contacted by the link worker at least 2 working days later, to gain verbal consent and for baseline data collection and randomisation.
The study recruitment target is 1,000 participants, randomized into two groups (a control group, n = 500 and an intervention group n = 500). The sample collected across the 3 General Practice clusters over the 24-month period that the study is open. An attrition rate of 5% is expected. Recruitment will end after 18-months, allowing for 6 months to complete the study and follow-up on participants. The service may continue independently of the study.
Data will be collected at a maximum of five time points:
- Prior to randomisation to either the immediate or wait-list arm
- For wait-list controls: in a reminder telephone call at the end of the 20 day wait
- At the end of their intervention with the link worker
- Four weeks after the end of their intervention with the link worker
- Three months after the end of the previous data collection point Data will be collected either over the telephone or during the intervention with the link workers. All link workers who are collecting data will have study specific training for receiving consent and data collection.
The study will take place over a 24-month period, with participant recruitment lasting a total of 18-months. Data analysis will take place at the end of the 24-month period, although transfer of data from the link workers to the research team at University of South Wales will be continuous over the 24-month period. A final report will be produced at the end of the study for the Welsh Government.
- Conditions
- Mental Health Wellness 1
- Being tested
- Immediate Appointment, Delayed appointment
- Keywords
- Waitlist
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 with the MIND Cymru 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 with the MIND Cymru 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 | Waitlist 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 Baseline. 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 statements can be scored 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 Baseline, 4 weeks and 3 months after randomisation.
Change from Baseline. Recovering Quality of Life questionnaire (ReQol - 20)
The Recovering Quality of Life questionaire is completed by the participants and allows self-reporting on their journey to recovery. There are twenty statements with five answers, and can be scored 0-4. The minimum score is 0 and the maximum is 80, where 0 indicates poorest quality of life and 80 indicates highest quality of life.
Measured: At Baseline, 4 weeks and 3 months after randomisation
Change from Baseline. The UCLA 3-Item Loneliness Scale
The UCLA 3-Item Loneliness Scale is completed by the participants and allows self-reporting of subjective feelings of loneliness and social isolation. There are three statements, with three answers, with "hardly ever", scoring 1 and "often" scoring 3. The minimum score is 3 and the maximum 9. A score of 3-5 is considered "not lonely" and 6-9 "lonely".
Measured: At Baseline, 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 posted20 Aug 2019
- Study start1 Oct 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: COVID Pandemic
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
- This study will employ a randomised waitlist trial design with mixed methods using a co-productive participatory approach.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- MIND Cymru
- Responsible party
- Sponsor
- Investigators
- Mark Llewellyn, Study director, University of South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062903
- Sponsor's protocol ID
- IRAS260516
- Acronym
- SPRING
- Status last verified
- Jun 2021
- First submitted
- 12 Aug 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the data
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mental Health Social Prescribing Trial (Mind Cymru)
- ClinicalTrials.gov ID
- NCT04062903
- Acronym / sponsor ID
- SPRING / IRAS260516
- Conditions
- Mental Health Wellness 1
- Keywords
- Waitlist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID Pandemic
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Collaborators
- MIND Cymru
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 20 Aug 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.
This study aims to evaluate a new social prescribing service delivered by Mind Cymru in four communities in Wales. Mind Cymru 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. The link worker will then help them find a service in their local community that might help them achieve their goals.
The study uses a waitlist trial, which means that 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, quality of life and loneliness questionnaires will be used to see the effects of the intervention on patients, whilst information like patient attendance at the General Practioner surgery will be used to see if there is a difference in the patient's use of health services.
Detailed description
This trial will employ a randomised wait-list control design. The study has been co-designed with the research team at University of South Wales, Mind Cymru, the link workers and General Practioners working within the study sites.
The study will assess the effectiveness of services provided through making three sets of comparisons (based on a set of individual- and service-level outcomes over time - comparing between: - The four Local Mind sites (Merthyr and Valleys, Vale of Clwyd, Brecon and District, Ystradgynlais);
- Those who complete the intervention immediately, with those who are in the waitlist group;
- Those who fully complete the social prescribing intervention with those who do not complete or partially the full social prescription but receive care as usual (either because they do not attend or only partially attend); and Participants will be randomly allocated to receive the social prescribing link worker intervention either immediately, or after a waiting period of 20 working days. Participants will be recruited through consultations with healthcare professionals, either their General Practioner, a practice nurse or the Total Nurse Triage system within the doctors surgery. If the healthcare professional identifies that the prospective participant meets the eligibility criteria of the study (experiencing mild/moderate mental health and/or emotional wellbeing disorders, aged 18+ and registered with a General Practioners in Wales), they will provide the prospective participant with an information pack, and ask for permission to contact. If this permission is given they will be subsequently contacted by the link worker at least 2 working days later, to gain verbal consent and for baseline data collection and randomisation.
The study recruitment target is 1,000 participants, randomized into two groups (a control group, n = 500 and an intervention group n = 500). The sample collected across the 3 General Practice clusters over the 24-month period that the study is open. An attrition rate of 5% is expected. Recruitment will end after 18-months, allowing for 6 months to complete the study and follow-up on participants. The service may continue independently of the study.
Data will be collected at a maximum of five time points:
- Prior to randomisation to either the immediate or wait-list arm
- For wait-list controls: in a reminder telephone call at the end of the 20 day wait
- At the end of their intervention with the link worker
- Four weeks after the end of their intervention with the link worker
- Three months after the end of the previous data collection point Data will be collected either over the telephone or during the intervention with the link workers. All link workers who are collecting data will have study specific training for receiving consent and data collection.
The study will take place over a 24-month period, with participant recruitment lasting a total of 18-months. Data analysis will take place at the end of the 24-month period, although transfer of data from the link workers to the research team at University of South Wales will be continuous over the 24-month period. A final report will be produced at the end of the study for the Welsh Government.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will employ a randomised waitlist 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 appointmentWaitlist 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 (e.g. anxiety or depression)
- Aged 18+ years
- Registered with a General Practioner in Wales
Key exclusion criteria (3 listed)
- Unable to give written, informed consent
- Unable to answer all questions (WEMWBS and EQ-5D) 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 with the MIND Cymru 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 with the MIND Cymru 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 Baseline. The Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) Score
Time frame: At Baseline, 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 statements can be scored 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 Baseline. Recovering Quality of Life questionnaire (ReQol - 20)
Time frame: At Baseline, 4 weeks and 3 months after randomisation
The Recovering Quality of Life questionaire is completed by the participants and allows self-reporting on their journey to recovery. There are twenty statements with five answers, and can be scored 0-4. The minimum score is 0 and the maximum is 80, where 0 indicates poorest quality of life and 80 indicates highest quality of life.
Change from Baseline. The UCLA 3-Item Loneliness Scale
Time frame: At Baseline, 4 weeks and 3 months after randomisation
The UCLA 3-Item Loneliness Scale is completed by the participants and allows self-reporting of subjective feelings of loneliness and social isolation. There are three statements, with three answers, with "hardly ever", scoring 1 and "often" scoring 3. The minimum score is 3 and the maximum 9. A score of 3-5 is considered "not lonely" and 6-9 "lonely".
Results and safety
The study was stopped early (reason given: COVID Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No. There is no plan to share the data
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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: stopped early, as of the sponsor's last update on 30 Jun 2021. 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 stopped early (reason given: COVID Pandemic). Results are not available in the source record.
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 Baseline. The Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) Score (time frame: At Baseline, 4 weeks and 3 months after randomisation.). The study lists 3 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 30 Jun 2021.