Social Prescribing Improving Mental Health Study

NCT04062903 | Terminated

• 1 other identifier: IRAS260516
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1

Keywords

Waitlist

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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".

  At Baseline, 4 weeks and 3 months after randomisation

Study Arms (2)

Immediate Appointment

ACTIVE COMPARATOR

Intervention group who receive the Social Prescription without delay. The effectiveness of the consultation and referral process will be assessed.

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.

Behavioral: Delayed appointment

Interventions

Immediate Appointment BEHAVIORAL

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.

Immediate Appointment

Delayed appointment BEHAVIORAL

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.

Delayed Appointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Wales: lead
• MIND Cymru: collaborator

Study Sites (1)

CTMUHB

Llantrisant, RCT, CF72 8XK, United Kingdom

Location

Study Officials

• Mark Llewellyn

  University of South Wales

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will employ a randomised waitlist trial design with mixed methods using a co-productive participatory approach.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 20, 2019
• Study Start: October 1, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)