The MEND Study protocol has been published and can be found on Science Direct under the title 'Mental health prevention and promotion in general practice settings: A protocol for a feasibility study.'

Ethical approval was granted from an NHS Research Ethics Committee (REC) and Health Research authority (HRA) (23/NW/0117) (IRAS: 323448).

Method

The MEND Study was a two-arm feasibility study where participants were randomly allocated to either treatment as usual (TAU), or treatment as usual in addition to a brief psychologically-informed intervention (MEND). 

Recruitment

Potential participants could enter the study via three different routes:

1. Self selection: Potential participants could contact a member of the study team to express interest in taking part after seeing a promotional poster, leaflet or advertisement on social media. A member of the study team would then have an initial study discussion with the individual and answer any questions.
2. Expression of interest after receiving an advertising text message: Some individuals were sent text messages via the GP surgery's electronic text messaging system to advertise the study. Recipients could express interest and a member of the study team would then have an initial discussion with the individual and answer any questions.
3. Referral from a General Practice staff member: Any General Practice staff member could tell a patient about The MEND Study and provide them with an information leaflet, if they thought they may benefit from study. With the patient's consent, the staff member would share the individual's contact details with the study team, who would then get in touch for an initial discussion.

Eligibility Criteria

The MEND Study had specific inclusion and exclusion criteria which was as follows:

Non-English speakers were not excluded from the study, as language line could be used to interpret appointments and information sheets were translated.

Inclusion criteria:

• Registered with GP in either PCN study site.
• Scored ≤14 on the GAD-7 and ≤15 on the PHQ-9.
• Aged 16 or older

Exclusion criteria:

• Already being supported by a mental health service/ engaging in therapy elsewhere.
• A formal diagnosis of a severe mental health difficulty.
• A moderate to severe learning disability where the support provided could not meet their need(s).
• Requiring support from crisis services.

Consent and randomisation

Informed consent was obtained from all potential participants during an appointment with a General Practice staff member who was separate from the study team.

Randomisation occurred through the utilisation of a randomised block design (with random block sizes of 4 or 6; chosen at random). An online software programme was used by an individual independent of the research team and the study's statistician was masked to arm allocation.