Primary care mental health Mental and Behavioural Disorders
Conditions
Interventions
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 ment
Sponsors
Lancashire & South Cumbria NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 t | — |
Countries
England, United Kingdom
Outcome results
None listed