REDUCE Work Stream 5 (WS5) Randomised Control Trial
Research type
Research Study
Full title
REviewing long term anti-DEpressant Use by Careful monitoring in Everyday practice (REDUCE) programme. Workstream 5 (WS5):Randomised Controlled Trial
IRAS ID
266517
Contact name
Tony Kendrick
Contact email
Sponsor organisation
RIS University of Southampton
ISRCTN Number
12417565
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
Research Summary
Around 1-in-10 adults are on antidepressants in England. Some need long-term treatment to prevent relapse, but a third-to-a-half could possibly stop them without relapsing. However, stopping is not always easy. Withdrawal symptoms can include anxiety and depression, which can feel similar to the reasons why patients first started antidepressants, so some people restart treatment quickly.
Common side effects of antidepressants include changes in weight, changes in sleep, and changes in libido or sexual functions. Less commonly, some patients develop bleeding from the stomach or intestine, and treatment of people over 65 is associated with increased falls, seizures, and strokes.
When GPs review patients on long-term antidepressants and recommend stopping them, only 1-in-14 is able to stop. Patients can be fearful and cessation can be tricky, so practitioners need to develop individual cessation strategies for each patient, and be able to offer them sustained support, especially in the first few weeks or months.
The REDUCE research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment, when appropriate. Work Stream 5 is a randomised trial to determine the effectiveness of Internet interventions on coming off antidepressants to support practitioners and patients, plus psychologist telephone support calls. It will take 36 months to complete, starting in November 2018, recruiting 402 patients (201 intervention and 201 controls), from 134 general practices over 15-18 months, and follow them up for 12 months. We will assess the effectiveness of the interventions in terms of reductions in antidepressant use in the absence of worsening of depression, and assess patients’ and practitioners’ use of the interventions.
A qualitative process evaluation will be conducted through interviews with 15-20 patients and 15-20 practitioners in each arm, to explore why the interventions were effective or not, depending on the results.Summary of Results
The REDUCE study tested internet and telephone support for people trying to stop long-term antidepressants when they no longer need them for depression. This can feel challenging due to fear that depression will return. Also people can get withdrawal symptoms which might make coming off treatment difficult.
Working with patients, GPs and other practitioners, we developed two websites to provide information and advice on coping with stopping antidepressants, called Advisor for patients and AdvisorHP for health professionals. We also developed guidance for psychological wellbeing practitioners to give support to people coming off antidepressants through three telephone calls.
We tested this approach in a trial. 178 people registered with 66 randomly selected practices received support from their GP plus internet and telephone support, and their success with stopping antidepressants was compared with success among 152 people from 65 practices providing GP support alone.
We found that 46% of the people who received the internet and telephone support managed to come off their antidepressant, slightly better than the 42% who came off them among the people with GP support alone. The internet and telephone support also seemed to protect people against depression returning, and against withdrawal symptoms, and their mental wellbeing was slightly better. This seemed to be because the support included advice to taper treatment slowly, and gave reassuring information on the difference between symptoms of depression and withdrawal symptoms, and what to do about them if they developed.
The support of the GP seemed most important, as people in both groups in the trial had little change in their quality of life, and harmful events were few and usually not serious. So attempting to taper off long-term antidepressants is a safe thing to do as long as the GP is monitoring a person’s progress and can adjust treatment as necessary.REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0144
Date of REC Opinion
2 Sep 2019
REC opinion
Favourable Opinion