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Trial of Internet and telephone support to people coming off long-term antidepressants

REviewing long term anti-DEpressant Use by Careful monitoring in Everyday practice (REDUCE) programme. Workstream 5 (WS5): Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12417565
Enrollment
360
Registered
2019-10-07
Start date
2020-01-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood [affective] disorders Mental and Behavioural Disorders Mood [affective] disorders

Interventions

The NHS funded six-year REDUCE (REviewing long term antiDepressant Use by Careful monitoring in Everyday practice) research programme aims to identify feasible, safe, effective, and cost-effective way
analyses of qualitative interviews and focus groups carried out with patients and practitioners respectively on the difficulties of antidepressant cessation in work stream 2
the development of the intervention using ‘think-aloud’ interviews with patients and practitioners in work stream 3
a feasibility randomised trial in work stream 4
the lived experience of our patient and public involvement (PPI) advisors
and our team's research and development expertise. WS5 is a fully powered randomised controlled trial (RCT), which aims to assess the effectiveness of the Internet and telephone interventions. It wil

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are taking long-term antidepressant treatment, which is not indicated according to the NICE depression guideline (NICE, 2009): 1.1 Treated for more than 1 year for a first episode, and 1.2 Treated for more than 2 years for a recurrent episode, who are: 1.3 No longer depressed or judged to be at significant risk of relapse 2. Adults over 18 years

Exclusion criteria

Exclusion criteria: 1. At risk for relapse: 1.1 Current significant depressive symptoms on the PHQ-9 (see below) despite antidepressant treatment 1.2 Current significant anxiety symptoms on the GAD-7 1.3 Current suicidal ideas 1.4 Current psychiatric outpatient or inpatient treatment for depression 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

MeasureTime frame
Depression measured by PHQ-9 score at baseline and 6 months

Secondary

MeasureTime frame
1. Depression measured by PHQ-9 score at baseline and 12 months 2. Discontinuation of antidepressants (for at least 2 months) measured at 6 months 3. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 6 and 12 months 4. Antidepressant withdrawal symptoms measured using the Discontinuation Emergent Signs and Symptoms Scale (DESS) at baseline, 3 and 6 months 5. Antidepressant side effects measured using the Antidepressant Side-Effects Check-list (ASEC) and Changes in Sexual Functioning Questionnaire (CSFQ-C) at baseline, 6 and 12 months 6. Patient satisfaction measured using a modified version of the 'Medical Interview Satisfaction Scale' (MISS-29) at 6 and 12 months 7. Enablement measured using the Patient Enablement Instrument (PEI) at 6 and 12 months 8. Quality of life measured using the EuroQol-5D-5L and Medical Outcomes Study Short Form SF-12 at baseline, 6 and 12 months 9. Use of services (to calculate costs) using a bespoke questionnaire at baseline, 6 and 12 months

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026