REDUCE Programme WS4: REviewing long term anti-DEpressant Use by Careful monitoring in Everyday practice

INTERVENTION: The trial is cluster randomised by participating general practices. Whole practices will be randomised to the intervention or control arms, rather than randomising individual patients, in order to avoid contamination between arms (the inadvertent application of the intervention to control patients). Randomisation will be computerised and carried out independently by the Southampton Clinical Trials Unit (SCTU). We will use the statistical technique of ‘minimisation’ to balance practice size (large/small), location (urban/rural), and social deprivation (dichotomised around the median Index of Multiple Deprivation (IMD) score). In the intervention arm, practitioners will receive education and advice on best practice in the supervision of antidepressant withdrawal. They will be given access to web‐based practitioner support modules and information and advice on patient monitoring during antidepressant withdrawal. The practitioner web‐based intervention (called ‘ADvisor’ as it gives advice about Anti‐Depressants) includes modules on: 1.Why reduce? 2. Broaching the subject 3. When to start tapering 4. Reduction schedules for individual antidepressants 5. Dealing with withdrawal symptoms 6. Dealing with relapse 7. ADvisor for patients (a summary) 8. Printable pages on antidepressant reduction regimes and sections of ADvisor for patients to recommend patients consult The number and timing of GP consultations during tapering will be left to the participating GPs to agree with the patients on an individual basis. Participating patients will be contacted by the research team, and given advice and support to log on and engage with their web‐based patient support. After looking at the web‐based support, patients will arrange to see their GP to discuss coming off antidepressants, including agreeing a time to start tapering the dose, and a first follow‐up appointment for review. The patient intervention (also called ‘ADvisor’) includes Internet modules on: 1. Reducing and stoppi CONDITION: Specialty: Primary Care, Primary sub‐specialty: Mental Health; Health Category: Mental health; Disease/Condition: Mood [affective] disorders ; Mental and Behavioural Disorders ; Long‐term use of antidepressants for depression INCLUSION CRITERIA: 1. Aged 18 years and over 2. On antidepressant treatment for more than 1 year for a first episode 3. Treated for more than 2 years for a recurrent episode 4. No longer depressed or judged to be at significant risk of relapse PRIMARY OUTCOME: 1. Patient follow‐up rate, assessed by the percentage of patients recruited who complete the Patient Health Questionnaire (PHQ‐9) at the 6 month follow‐up:; 1.1. If this is less than 70% the main trial will not proceed; 1.2. If it is greater than 80% the main trial will proceed; 1.3. If it is between 70% and 80% it will proceed provided measures can be put in place to reassure the funder that follow‐up can be increased to 80%; 2. The willingness of general practices to be recruited to the study based on the number of expressions of interest and subsequent recruitment ‐ the percentage of practices approached who complete participation in the study, assessed at the end of the patient follow‐up; 3. The willingness of practices to be randomised to intervention or control arms of the study as whole practices, in a cluster randomised design ‐ the percentage of practices which withdraw from the study, assessed after randomisation and before the end of the patient follow‐up; 4. The willingness and ability of general practitioners (GPs) and nurse practitioners (NPs) to recruit and randomise patients to the two arms of the study in consultations for the follow‐up of patients taking antidepressants for depression, based on recruitment rates and feedback in qualitative interviews at the end of the patient follow‐up; 5. The mean number of eligible patients found per practice through the database searches at the end of the patient follow‐up; 6. Recruitment rates among eligible patients identified through the searches and contacted by post at the end of the patient follow‐up; 7. The willingness of patients to engage with the Internet intervention and telephone support in the intervention arm based on intervention use data and qualitative interviews at the end of the patient follow‐up; 8. The willingness of patients to have their PP telephone support calls based on PP support call uptake and qualitative interviews at the end of the patient follow‐up; 9. The acceptability of the proposed research outcome measures to patients, in both intervention and control arms, measured using a Likert rating scale during researcher visits at the end of the patient follow‐up; 10. Response rates to research outcome measures administered by post and followed up by face‐to‐face or telephone administration where necessary at the end of the patient follow‐up; 11. The intra‐cluster correlation coefficient (ICC) between practices for depressive symptoms on the PHQ‐9 (to help inform the sample size calculation for the main trial, along with published ICCs from other trials), assessed at the end of data analysis, following the end of patient follow‐up; SECONDARY OUTCOME: The following will be collected using postal questionnaires, followed up by telephone calls and face‐to‐face visits where necessary:; 1. Depression, assessed using the Patient Health Questionnaire (PHQ‐9) at the baseline and after 3, 9 and 12 months; 2. Anxiety, assessed using the 7‐item Generalised Anxiety Disorder questionnaire (GAD‐7) at the baseline and after 3, 6, 9 and 12 months; 3. Discontinuation of anti‐depressants, defined as no use for 2 months from results of the Patient Use of Antidepressant Questionnaire, assessed at the baseline and after 6 months; 4. Dose of antidepressant (if not discontinued), assessed using the Patient Use of Antidepressant Questionnaire at the baseline and after after 6 months; 5. Quality of life, assessed at the baseline and after 3, 6, 9 and 12 months using:; 5.1. EuroQol questionnaire (EQ‐5D‐5L); 5.2. Medical Outcomes Study Short Form (SF‐12); 6. Wellbeing, assessed using the Warwick‐Edinburgh Mental Wellbeing Scale (WEMWBS) at the baseline and after 3 months; 7. Withdrawal symptoms, assessed using the Discontinuation Emergent Signs and Symptoms Scale (DESS) at the baseline and after 3 months; 8. Antidepressant side effects, assessed at the baseline and after 3, 6 and 12 months:; 8.1. Antidepressant side effects checklist (ASEC); 8.2. Changes in Sexual Functioning Questionnaire (CSFQ‐C); 9. Patient satisfaction, assessed using the Medical Interview Satisfaction Scale (MISS‐29) at the baseline and after 6 months:; 10. Enablement, assessed using the Patient Enablement Instrument at the baseline and after 6 months; 11. Costs, assessed using a bespoke questionnaire at the baseline and after 3, 6, 9 and 12 months;