Discontinuation of antidepressant medication in primary care supported by monitoring plus mindfulness-based cognitive therapy versus monitoring alone: design and protocol of a cluster randomized controlled trial

Carolien Wentink,Reinier Akkermans,Jan Spijker,Marloes J Huijbers,Anne E M Speckens,Eddy Adang,Peter Lucassen,Cornelis Kramers

doi:10.1186/s12875-019-0989-5

Abstract

BackgroundAntidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners (GPs). Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.MethodsThis study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of SPD and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.DiscussionIn theory, stopping antidepressant medication seems straightforward. In practice however, patients and their GPs appear reluctant to initiate and accomplish this process. Both patients and professionals are in need of appropriate tools and information to better support the process of discontinuing antidepressant medication.Trial registrationClinicalTrials.gov PRS ID: NCT03361514 retrospectively registered October 2017.

Highlights

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment
Design This study is designed as a cluster-randomized controlled trial conducted in primary care with General Practitioner (GP)’s that work with a mental health assistant (MHA), randomizing patients at the level of their GPs over a) Supported Protocolized Discontinuation (SPD) alone or b) SPD with additional Mindfulness-Based Cognitive Therapy (MBCT)
We will conduct one-on-one, in-depth interviews with a purposive sample of patients willing to discontinue their antidepressant medication about barriers and facilitators of this process. Both patients and professionals seem to call for appropriate tools and information to better support the process of discontinuing antidepressant medication

Summary

Introduction

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Despite being effective for some patients in reducing symptoms of depression and anxiety and reducing the risk of depressive relapse [3] antidepressants may have side effects such as sleep disturbance, weight gain, sexual dysfunction and gastrointestinal bleeding [4, 5]. They sometimes even go along with more serious adverse events, such as falls, attempted suicide or self harm, stroke and epilepsy [6]. The pace of tapering seems important as it appears to influence the risk of relapse in patients with depressive disorder [8]

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