Depression Mental and Behavioural Disorders Long-term use of antidepressants for depression
Conditions
Interventions
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 avo
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Significant risk factors for relapse, including: 1.1. Current significant depressive symptoms on the PHQ-9 (score 12+) despite antidepressant treatment 1.2. Current significant anxiety symptoms on the GAD-7 (score 10+) 1.3. Current suicidal ideas 1.4. Depression needing current psychiatric outpatient or inpatient treatment 2. Bipolar disorder, comorbid psychosis, substance use, or dementia as a primary diagnosis 3. Spoken or written English language inadequate to take part in interviews or complete questionnaires 4. Another indication for taking antidepressants, e.g. neuropathic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 res | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactWendy O'Brien
Outcome results
None listed