Mental health prevention and promotion in general practice settings
| ISRCTN | ISRCTN52372836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52372836 |
| IRAS number | 323448 |
| Secondary identifying numbers | CPMS 56061, NIHR204332, IRAS 323448 |
- Submission date
- 13/06/2023
- Registration date
- 05/07/2023
- Last edited
- 28/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The number of people struggling with their mental health is rising. Soon, the NHS may not be able to meet the demand on mental health services. Offering preventative mental health support may stop people from developing more serious mental health problems. The study aims to understand how preventative mental health support can be delivered in a general practice (GP) setting.
The study will recruit individuals from GP settings and randomly allocate them to two groups. One group will be invited to engage in a brief, menu-based psychological intervention alongside their treatment as usual. The main aim of the intervention is to explore if it’s possible to help people when they are first struggling, by teaching them how to look after their emotional wellbeing. The second group will receive treatment as usual and the research team will stay in touch with them too.
The feasibility study will test:
1. Whether people are happy to sign-up for, and then stay in the study.
2. Whether people are happy to fill in questionnaires about their wellbeing.
3. What helped, or indeed, stopped the study from running smoothly.
4. Whether the study is safe for everyone involved.
We will look at how many people sign up, attend or drop out of the intervention to answer these questions. Questionnaires/interviews will be done with participants, GP staff and the assistant psychologists to understand why the intervention service worked/did not work and how they felt about the study design.
As a new area of research, this ‘feasibility study’ is needed to help design, plan and justify a larger study.
Who can participate?
60 adult patients at GP surgeries in East Lancashire, with mild-moderate mental health difficulties who agree to participate.
What does the study involve?
Half of the patients will receive the usual input from their GPs (10-minute appointments). The rest will be offered five weekly 45 minutes of the intervention session.
What are the possible benefits and risks of participating?
If you choose to participate in the study there is a possibility that you will be allocated to the group which does not receive the brief psychological intervention. On the other hand, if you are allocated to the group that receives the psychological intervention there may be times when you find talking about your mental health upsetting. For some people talking about their mental health can be hard however you will be supported by an appropriately trained professional.
The aim of the psychological intervention is to help you feel better and to help you understand how to care for your mental health, just like you do your physical health. Therefore, it is hoped that the benefits of receiving the intervention will be improved emotional wellbeing.
Where is the study run from?
Lancashire & South Cumbria NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2023 to June 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Farah Lunat, Farah.lunat@lscft.nhs.uk
Contact information
Principal Investigator
Lancashire & South Cumbria NHS Foundation Trust
Trust HQ
Sceptre Point
Sceptre Way
Walton Summit
Preston
PR5 6AW
United Kingdom
| miranda.budd@lscft.nhs.uk |
Study information
| Study design | Interventional mixed methods |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Mental health prevention and promotion in general practice settings: a feasibility study |
| Study acronym | MEND |
| Study objectives | Will patients registered at a general practice, presenting with mild-moderate mental health difficulties, be willing to be randomised to a study investigating the efficacy of a brief mental health prevention and promotion intervention? |
| Ethics approval(s) |
Approved 10/05/2023, Health Research Authority (Skipton House, 80 London Road, London, SE1 6LH, United Kingdom; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 23/NW/0117 |
| Health condition(s) or problem(s) studied | Primary care mental health |
| Intervention | Patients who meet the criteria and agree to participate in the study will be randomised to either: - treatment as usual within general practice - treatment as usual within general practice plus a mental health prevention and promotion intervention The mental health prevention and promotion intervention can be delivered either face-to-face in the GP surgery or virtually by an Assistant Psychologist, who has undergone an initial intensive 2-week training in the delivery of brief interventions for prevention and promotion. The virtual delivery method would be via integrated software such as ACCURX or iplato, which are both currently used by the practices in the two PCNs. The training the Assistant Psychologists will receive will be provided by qualified psychological professionals and focus on the principles and applications of different psychological techniques used in brief interventions. The Assistant Psychologists will also be provided with weekly individual clinical supervision by a Clinical Psychologist. Control group: To mimic mental health treatment as usual in general practice, participants in both study arms will be able to access GP appointments as normal. Within these appointments, GP staff will be able to provide any usual form of mental health treatment, such as advice or medication. This feasibility study will collate data about the care each participant receives. Intervention group: The intervention group will receive additional input through a brief psychological intervention aimed at preventing mental ill-health, or deterioration. This is a brief one-to-one psychological menu-based intervention focusing on preventing mental health deterioration and promoting the importance of caring for one’s emotional wellbeing. The intervention consists of four 45-minute appointments delivered weekly, over 5 sessions Follow up for 16 weeks. Qualitative and Process Evaluation Qualitative data will be collected to understand factors that facilitate or challenge the successful implementation of interventions and a process evaluation will be conducted to provide insight into the intervention's mechanisms of action. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Depression measured using PHQ-9 2. Anxiety measured using GAD-7 3. Mental wellbeing measured using WEMWBS 4. Resilience measured using BRS Measured at: INTERVENTION ARM - engagement session (consent), first session (if engagement session was longer than 2 weeks ago), fourth session, Post-intervention (4-weeks post-baseline), 4-week follow up (8-weeks post-baseline), 8-week follow up (12-weeks post-baseline), 12-week follow up (16-weeks post-baseline). CONTROL ARM - engagement session (consent) and 16 weeks later. |
| Secondary outcome measures | Cost-effectiveness outcome measures at baseline and the final follow-up (16 weeks): 1. Patients' resource use captured using a questionnaire and patient note review. The information to be collected from the participants' electronic health records (EHR) will be: NHS Consultations and referrals; A&E admissions and stays in hospital; Prescribed medication. The EHR that will be accessed is known as EMIS- the EHR used within the GP practices in Pendle West and Burnley East PCN. The questionnaire will collate information about: Private consultations and stays; Over-the-counter medication use; Special items or equipment. 2. Patients’ health-related quality of life (HRQoL) measured using EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L; 34) questionnaire Qualitative and Process Evaluation Qualitative data will be collected to understand factors that facilitate or challenge the successful implementation of interventions and a process evaluation will be conducted to provide insight into the intervention's mechanisms of action. Participants: a patient experience questionnaire will be used to assess intervention acceptability. Semi-structured interviews will be conducted with a sample of participants (10 per arm), to explore their experience of the study and perceived mechanisms for change. General practice staff: A feedback questionnaire will be distributed to GP staff, to understand their experiences and any changes required for a full study. A semi-structured interview with three staff members will also be conducted. Research team: Field notes from the research team will identify factors that supported/impeded the feasibility study. A semi-structured interview will be conducted with the two Assistant Psychologists to understand their perceived mechanisms of change and patient safety processes. Questionnaire responses will be collated, and interviews transcribed. Qualitative analysis will be conducted by the qualitative lead, KG, using NVivo, to provide a comprehensive response to the research questions. Furthermore, the process evaluation will allow for the identification of any mediating variables which should be measured in a full study. |
| Overall study start date | 01/03/2023 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Registered at the research site's General Practice 2. Score <=14 on the GAD-7 and <=15 on the PHQ-9 at screening 3. Aged 16 years and above |
| Key exclusion criteria | 1. Already supported by a mental health service/ engaged in therapy 2. Score >=15 on the GAD-7 and/or >=16 on the PHQ-9 at screening 3. Have a formal diagnosis of a severe mental health difficulty, where it would not be possible to meet their needs with four sessions 4. Require support from crisis services 5. Have a moderate-severe learning disability, where their needs could only be met within a specialist service. |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 09/02/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
Sponsor information
Hospital/treatment centre
Sceptre Point
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
England
United Kingdom
| Phone | +44 (0)7507847609 |
|---|---|
| andrew.pennington@lscft.nhs.uk |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Study sponsor R&D department, research.office@lscft.nhs.uk. Data available will be Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices). The data will be available following study close out ending 5 years following article publication. Data will be available to Researchers who provide a methodologically sound proposal in order to achieve aims identified in the proposal. Data will be accessible on a secure NHS server and access will be facilitated by the research office but without investigator support other than deposited metadata. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
28/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/02/2024 to 09/02/2024.
2. The overall end date was changed from 31/05/2024 to 30/06/2024.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
05/12/2023: The recruitment end date has been changed from 29/12/2023 to 29/02/2024.
20/09/2023: A link to the HRA research summary was added.
13/06/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
