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

ABSTRACT: 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).

SUBMITTER: Huijbers MJ

PROVIDER: S-EPMC10479886 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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

Huijbers Marloes J MJ Wentink Carolien C Lucassen Peter L B J PLBJ Kramers Cornelis C Akkermans Reinier R Spijker Jan J Speckens Anne E M AEM

PloS one 20230905 9

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 allocat ...[more]

PMID: 37669281

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Project description:ObjectivesWe developed a complex intervention called DECIDE (ComputeriseD dECisIonal support for suboptimally controlleD typE 2 Diabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact of DECIDE.DesignA pilot cluster randomised controlled trial.SettingConducted in 14 practices in Irish General Practice.ParticipantsThe DECIDE intervention was targeted at GPs. They applied DECIDE to patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ≥70 mmol/mol and/or blood pressure ≥150/95 mmHg.InterventionThe intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care. Control practices delivered usual care.Primary and secondary outcome measuresFeasibility and acceptability was determined using thematic analysis of semi-structured interviews with GPs, combined with data from the DECIDE website. Clinical outcomes included HbA1c, medication intensification, blood pressure and lipids.ResultsWe recruited 14 practices and 134 patients. At 4-month follow-up, all practices and 114 patients were followed up. GPs reported finding decision support helpful navigating increasingly complex medication algorithms. However, the majority of GPs believed that the target patient group had poor engagement with GP and hospital services for a range of reasons. At follow-up, there was no difference in glycaemic control (-3.6 mmol/mol (95% CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services. Continuation criteria supported proceeding to a definitive randomised trial with some modifications.ConclusionThe DECIDE study was feasible and acceptable to GPs but wider impacts on glycaemic and blood pressure control need to be considered for this patient population going forward.Trial registration numberISRCTN69498919.

Project description:BackgroundIncreasing numbers of family carers are providing informal care in community settings. This creates a number of challenges because family carers are at risk of poor physical and psychological health outcomes, with consequences both for themselves and those for whom they provide care. General Practitioners (GPs), who play a central role in community-based care, are ideally positioned to identify, assess, and signpost carers to supports. However, there is a significant gap in the literature in respect of appropriate guidance and resources to support them in this role.MethodsA scoping review was undertaken to examine clinical guidelines and recommendations for GPs to support them in their role with family carers. This involved a multidisciplinary team, in line with Arksey & O'Malley's framework, and entailed searches of ten peer-reviewed databases and grey literature between September-November 2020.ResultsThe searches yielded a total of 4,651 English language papers, 35 of which met the criteria for inclusion after removing duplicates, screening titles and abstracts, and performing full-text readings. Ten papers focused on resources/guidelines for GPs, twenty were research papers, three were review papers, one was a framework of quality markers for carer support, and one was an editorial. Data synthesis indicated that nine (90%) of the guidelines included some elements relating to the identification, assessment, and/or signposting of carers. Key strategies for identifying carers suggest that a whole practice approach is optimal, incorporating a role for the GP, practice staff, and for the use of appropriate supporting documentation. Important knowledge gaps were highlighted in respect of appropriate clinical assessment and evidence-based signposting pathways.ConclusionOur review addresses a significant gap in the literature by providing an important synthesis of current available evidence on clinical guidelines for GPs in supporting family carers, including strategies for identification, options for assessment and potential referral/signposting routes. However, there is a need for greater transparency of the existing evidence base as well as much more research to evaluate the effectiveness and increase the routine utilisation, of clinical guidelines in primary care.

Project description:ObjectiveTo explore the reasons behind the recent increase in antidepressant prescribing in the United Kingdom. Design Detailed retrospective analysis of data on general practitioner consultations and antidepressant prescribing. Data source Data were obtained from the general practice research database, which contains linked anonymised records of over 3 million patients registered in the UK. Data were extracted for all new incident cases of depression between 1993 and 2005. Review methods Detailed analysis of general practitioner consultations and antidepressant prescribing was restricted to 170 practices that were contributing data for the full duration of the study.ResultsIn total, 189 851 people within the general practice research database experienced their first episode of depression between 1993 and 2005, of whom 150,825 (79.4%) received a prescription for antidepressants in the first year of diagnosis. This proportion remained stable across all the years examined. The incidence of new cases of depression rose in young women but fell slightly in other groups such that overall incidence increased then declined slightly (men: 7.83 cases per 1000 patient years in 1993 to 5.97 in 2005, women: 15.83 cases per 1000 patient years in 1993 to 10.06 in 2005). Antidepressant prescribing nearly doubled during the study period-the average number of prescriptions issued per patient increased from 2.8 in 1993 to 5.6 in 2004. The majority of antidepressant prescriptions were given as long term treatment or as intermittent treatment to patients with multiple episodes of depression.ConclusionsThe rise in antidepressant prescribing is mainly explained by small changes in the proportion of patients receiving long term treatment. Previous clinical guidelines have focused on antidepressant initiation and appropriate targeting of antidepressants. To address the costly rise in antidepressant prescribing, future research and guidance needs to concentrate on appropriate long term prescribing for depression and regular review of medication.

Project description:ObjectivesThis 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.DesignMixed-methods study combining quantitative and qualitative data, drawn from a randomised controlled trial.SettingTwelve secondary and tertiary psychiatric outpatient clinics in the Netherlands.ParticipantsRecurrently 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.InterventionsAll participants were offered MBCT, which consisted of eight weekly sessions in a group.Primary and secondary outcome measuresDemographic 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.ResultsOf 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.ConclusionsDiscontinuing 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 numberClinicalTrials.gov Registry (NCT00928980); post-results.

Dataset Information

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

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

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