Clinical trial NCT04062903: Social Prescribing Improving Mental Health Study
Official title: A Mental Health Social Prescribing Trial (Mind Cymru)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Waitlist
Lead sponsor: University of South Wales
Sponsor class: OTHER
Collaborators: name: MIND Cymru
First posted: 2019-08-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will employ a randomised waitlist trial design with mixed methods using a co-productive participatory approach.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline. The Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) Score
timeFrame: At Baseline, 4 weeks and 3 months after randomisation.
measure: Change from Baseline. Recovering Quality of Life questionnaire (ReQol - 20)
timeFrame: At Baseline, 4 weeks and 3 months after randomisation
measure: Change from Baseline. The UCLA 3-Item Loneliness Scale
timeFrame: At Baseline, 4 weeks and 3 months after randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: Llantrisant
country: United Kingdom
facility: CTMUHB
state: RCT
Study officials:
affiliation: University of South Wales
name: Mark Llewellyn
role: STUDY_DIRECTOR
References: