A Mental Health Social Prescribing Trial (British Red Cross) (PROSPECT)

February 24, 2022 updated by: University of South Wales

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Pontypridd, United Kingdom, cf37 1dl
        • University of South Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immediate Appointment
Intervention group who receive the Social Prescription without delay. The effectiveness of the consultation and referral process will be assessed
Behavioral: Immediate Appointment
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
Active Comparator: Delayed Appointment
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
Behavioral: Delayed Appointment
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At Base-line, 4 weeks and 3 months after randomisation
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.
At Base-line, 4 weeks and 3 months after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Wales

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Red Cross

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mark Llewellyn, University of South Wales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS 261969

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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