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.

BACKGROUND: Antidepressant 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. METHODS: This 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. DISCUSSION: In 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 REGISTRATION: ClinicalTrials.gov PRS ID: NCT03361514 retrospectively registered October 2017.

Supporting antidepressant discontinuation using mindfulness plus monitoring versus monitoring alone: A cluster randomized trial in general practice.

Discontinuing antidepressant medication (ADM) can be challenging for patients and clinicians. In the current study we investigated if Mindfulness-Based Cognitive Therapy (MBCT) added to supported protocolized discontinuation (SPD) is more effective than SPD alone to help patients discontinue ADM. This study describes a prospective, cluster-randomized controlled trial (completed). From 151 invited primary care practices in the Netherlands, 36 (24%) were willing to participate and randomly allocated to SPD+MBCT (k = 20) or SPD (k = 16). Adults using ADM > 9 months were invited by GPs to discuss tapering, followed by either MBCT+SPD, or SPD alone. Exclusion criteria included current psychiatric treatment; substance use disorder; non-psychiatric indication for ADM; attended MBCT within past 5 years; cognitive barriers. From the approximately 3000 invited patients, 276 responded, 119 participated in the interventions and 92 completed all assessments. All patients were offered a decision aid and a personalized tapering schedule (with GP). MBCT consisted of eight group sessions of 2.5 hours and one full day of practice. SPD was optional and consisted of consultations with a mental health assistant. Patients were assessed at baseline and 6, 9 and 12 months follow-up, non-blinded. In line with our protocol, primary outcome was full discontinuation of ADM within 6 months. Secondary outcomes were depression, anxiety, withdrawal symptoms, rumination, well-being, mindfulness skills, and self-compassion. Patients allocated to SPD + MBCT (n = 73) were not significantly more successful in discontinuing (44%) than those allocated to SPD (n = 46; 33%), OR 1.60, 95% CI 0.73 to 3.49, p = .24, number needed to treat = 9. Only 20/73 allocated to MBCT (27%) completed MBCT. No serious adverse events were reported. In conclusion, we were unable to demonstrate a significant benefit of adding MBCT to SPD to support discontinuation in general practice. Actual participation in patient-tailored interventions was low, both for practices and for patients. (Trial registration: ClinicalTrials.gov PRS ID: NCT03361514 registered December 2017).

Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers.

OBJECTIVES: This study aimed to explore predictors and outcomes associated with different trajectories of discontinuing antidepressant medication (ADM), in recurrently depressed individuals after participation in mindfulness-based cognitive therapy (MBCT). Facilitators and barriers of discontinuation were explored qualitatively. DESIGN: Mixed-methods study combining quantitative and qualitative data, drawn from a randomised controlled trial. SETTING: Twelve secondary and tertiary psychiatric outpatient clinics in the Netherlands. PARTICIPANTS: Recurrently depressed individuals (N=226) who had been using ADM for at least 6 months and in partial or full remission. Regardless of trial condition, we made post-hoc classifications of patients' actual discontinuation trajectories: full discontinuation (n=82), partial discontinuation (n=34) and no discontinuation (n=110) of ADM within 6 months after baseline. A subset of patients (n=15) and physicians (n=7) were interviewed to examine facilitators and barriers of discontinuation. INTERVENTIONS: All participants were offered MBCT, which consisted of eight weekly sessions in a group. PRIMARY AND SECONDARY OUTCOME MEASURES: Demographic and clinical predictors of successful discontinuation within 6 months, relapse risk within 15 months associated with different discontinuation trajectories, and barriers and facilitators of discontinuation. RESULTS: Of the 128 patients assigned to MBCT with discontinuation, only 68 (53%) fully discontinued ADM within 6 months, and 17 (13%) discontinued partially. Predictors of full discontinuation were female sex, being employed and lower levels of depression. Relapse risk was lower after no discontinuation (45%) or partial discontinuation (38%), compared with full discontinuation (66%) (p=0.02). Facilitators and barriers of discontinuation were clustered within five themes: (1) pre-existing beliefs about depression, medication and tapering; (2) current experience with ADM; (3) life circumstances; (4) clinical support and (5) mindfulness. CONCLUSIONS: Discontinuing antidepressants appears to be difficult, stressing the need to support patients and physicians in this process. MBCT may offer one of these forms of support. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT00928980); post-results.

Enhancing shared decision making about discontinuation of antidepressant medication: a concept-mapping study in primary and secondary mental health care.

BACKGROUND: The apparent rise of antidepressant use seems to be explained to a large extent by an increase in long-term use. Both professionals and patients appear reluctant to discontinue antidepressant medication (ADM). It is not known what factors determine this reluctance. AIM: This study aimed to identify factors that enable the shared decision-making process about discontinuation of ADM between long-term users and their GPs. DESIGN AND SETTING: Concept-mapping study of a purposive sample of both patients and professionals from primary and secondary mental health care in the Netherlands. METHOD: Concept mapping was used to conceptualise and structure the topics relevant to the discontinuation process from the perspective of both patients and professionals. Participants generated topics in brainstorming sessions and subsequently prioritised and sorted them. Multidimensional scaling and hierarchical cluster analyses were used for the cluster topics. RESULTS: Thirty-seven patients and 27 professionals generated 50 separate topics. Hierarchical cluster analysis revealed six clusters of topics: 'Process of discontinuation', 'Expectations', 'Professional guidance', 'Current use', 'Environment', and 'Side effects'. Patients and professionals came up with largely similar topics. Nevertheless, a difference was found between these groups regarding the perceived importance of professional guidance. CONCLUSION: This study yielded an informed selection of the topics that seem most important to discuss when considering whether to discontinue ADM. As perspectives of both patients and professionals were combined, the topics may provide patients and GPs with a broader and more balanced scope of factors to consider, and thus facilitate a better shared decision-making process.