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

• Published in: PloS one 2023-09, Vol.18 (9), p.e0290965
• Main Authors: Huijbers, Marloes J, Wentink, Carolien, Lucassen, Peter L B J, Kramers, Cornelis, Akkermans, Reinier, Spijker, Jan, Speckens, Anne E M
• Format: Article
• Language: English
• Subjects: Access control; Adult; Antidepressants; Antidepressive Agents; Anxiety; Care and treatment; Clusters; Cognitive ability; Cognitive therapy; Evaluation; Family medicine; Family Practice; General Practice; Humans; Intervention; Medical research; Medicine and Health Sciences; Medicine, Experimental; Mental depression; Mental health; Mindfulness; Mindfulness meditation; Monitoring; Nurses; Patients; People and Places; Physicians (General practice); Primary care; Prospective Studies; Psychiatric services; Psychological aspects; Remission (Medicine); Rumination; Self compassion; Self-care, Health; Substance abuse; Substance abuse treatment; Substance use; Tapering; Telemedicine; Well being; Withdrawal
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0290965

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).