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).

Experiences of Clinical Clerkship Students With Mindfulness-Based Stress Reduction: A Qualitative Study on Long-Term Effects.

Purpose: To explore the mindfulness practice, its long-term effects, facilitators and barriers, in clinical clerkship students 2 years after participation in an 8-week mindfulness-based stress reduction (MBSR) training. Method: A qualitative study was performed by semi-structured in-depth interviews with 16 clinical clerkship students selected by purposive sampling. Students had participated in a MBSR training 2 years before and were asked about their current mindfulness practice, and the long-term effects of the MBSR training. Thematic analysis was conducted using the constant comparison method. Data saturation was reached after 16 interviews. Results: Most interviewees were still engaged in regular, predominantly informal, mindfulness practice, although some discontinued mindfulness practice and reported an "unchanged lifestyle." Three main themes came forward; (1) "focused attention and open awareness" during daily activities as core elements of long-term mindfulness practice; (2) "changes in behavior and coping" that resulted from taking a pause, reflecting, recognizing automatic behavioral patterns and making space for a conscious response; (3) "integration in personal and professional life" by enhanced enjoyment of daily activities, improved work-life-balance and making different career choices. Barriers and facilitators in starting and maintaining mindfulness practice were (1) understanding and intention as "pre-conditions"; (2) practical, personal, and professional factors of students in maintaining practice. Conclusion: Two years after participation in a MBSR training, many interviewees were still engaged in (mostly informal) mindfulness practice contributing to both personal and professional changes. In light of the high clerkship demands, MBSR training could be a valuable addition to medical curricula, supporting medical students in developing necessary competencies to become well-balanced professionals.

A cross-sectional examination of psychological distress, positive mental health and their predictors in medical students in their clinical clerkships.

BACKGROUND: Medical students can experience the transition from theory to clinical clerkships as stressful. Scientific literature on the mental health of clinical clerkship students is scarce and mental health is usually defined as absence of psychological distress without assessing psychological, emotional and social wellbeing, together called 'positive mental health'. This cross-sectional study examines the prevalence of psychological distress and positive mental health and explores possible predictors in a Dutch sample of clinical clerkship students. METHODS: Fourth-year medical students in their first year of clinical clerkships were invited to complete an online questionnaire assessing demographics, psychological distress (Brief Symptom Inventory), positive mental health (Mental Health Continuum- SF), dysfunctional cognitions (Irrational Beliefs Inventory) and dispositional mindfulness skills (Five Facet Mindfulness Questionnaire). Multiple linear regression analysis was used to explore relationships between psychological distress, positive mental health (dependent variables) and demographics, dysfunctional cognitions and dispositional mindfulness skills (predictors). RESULTS: Of 454 eligible students, 406 (89%) completed the assessment of whom 21% scored in the clinical range of psychological distress and 41% reported a flourishing mental health. These proportions partially overlap each other. Female students reported a significantly higher mean level of psychological distress than males. In the regression analysis the strongest predictors of psychological distress were 'acting with awareness' (negative) and 'worrying' (positive). Strongest predictors of positive mental health were 'problem avoidance' (negative) and 'emotional irresponsibility' (negative). CONCLUSIONS: The prevalence of psychopathology in our sample of Dutch clinical clerkship students is slightly higher than in the general population. Our results support conclusions of previous research that psychological distress and positive mental health are not two ends of one continuum but partially overlap. Although no conclusion on causality can be drawn, this study supports the idea that self-awareness and active, nonavoidant coping strategies are related to lower distress and higher positive mental health.

Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial.

PURPOSE: To examine the effect of mindfulness-based stress reduction training (MBSR) on the mental health of medical students during clinical clerkships. METHOD: Between February 2011 and May 2014, the authors conducted a cluster-randomized controlled trial of clerkships as usual (CAU) and clerkships with additional MBSR in medical students during their first year of clinical clerkships at a Dutch university medical center. MBSR consisted of eight weekly two-hour sessions, comprising didactic teaching, meditation exercises, and group dialogues. Students completed online assessments at baseline and after 3, 7, 12, 15, and 20 months. Outcome measures were psychological distress, positive mental health, life satisfaction, physician empathy, mindfulness skills, and dysfunctional cognitions as measured by validated tools. RESULTS: Of 232 eligible students, 167 students (72%) participated and were randomized by clerkship group into MBSR (n = 83) or CAU (n = 84). The MBSR group reported a small reduction of psychological distress (P = .03, Cohen's d = 0.20) and dysfunctional cognitions (P = .05, Cohen's d = 0.18) and a moderate increase of positive mental health (P = .002, Cohen's d = 0.44), life satisfaction (P = .01, Cohen's d = 0.51), and mindfulness skills (P = .05, Cohen's d = 0.35) compared with CAU during the 20-month follow-up. The authors detected no significant effect on physician empathy (P = .18, Cohen's d = 0.27). CONCLUSIONS: MBSR appeared feasible and acceptable to medical clerkship students and resulted in a small to moderate improvement of mental health compared with CAU over the 20-month follow-up.

Mindfulness-based stress reduction for GPs: results of a controlled mixed methods pilot study in Dutch primary care.

BACKGROUND: Burnout is highly prevalent in GPs and can have a negative influence on their wellbeing, performance, and patient care. Mindfulness-based stress reduction (MBSR) may be an effective intervention to decrease burnout symptoms and increase wellbeing. AIM: To gain insight into the feasibility and effectiveness of MBSR on burnout, empathy, and (work-related) wellbeing in GPs. DESIGN AND SETTING: A mixed methods pilot study, including a waiting list-controlled pre-/post-study and a qualitative study of the experiences of participating GPs in the Netherlands. METHOD: Participants were sent questionnaires assessing burnout, work engagement, empathy, and mindfulness skills, before and at the end of the MBSR training/waiting period. Qualitative data on how GPs experienced the training were collected during a plenary session and with evaluation forms at the end of the course. RESULTS: Fifty Dutch GPs participated in this study. The MBSR group reported a greater decrease in depersonalisation than the control group (adjusted difference -1.42, 95% confidence interval [CI] = -2.72 to -0.21, P = 0.03). Dedication increased more significantly in the MBSR group than in the control group (adjusted difference 2.17, 95% CI = 0.51 to 3.83, P = 0.01). Mindfulness skills increased significantly in the MBSR group compared with the control group (adjusted difference 6.90, 95% CI = 1.42 to 12.37, P = 0.01). There was no significant change in empathy. The qualitative data indicated that the MBSR course increased their wellbeing and compassion towards themselves and others, including their patients. CONCLUSION: The study shows that MBSR for GPs is feasible and might result in fewer burnout symptoms and increased work engagement and wellbeing. However, an adequately powered randomised controlled trial is needed to confirm the study's findings.

Mindfulness-based cognitive therapy (MBCT) for patients with medically unexplained symptoms: process of change.

BACKGROUND: A recent randomized controlled trial provided preliminary evidence for the effectiveness of mindfulness based cognitive therapy (MBCT) for the top 10% frequent attenders in primary care with persistent medically unexplained symptoms (MUS). This qualitative study aims to explore working mechanisms and possible barriers of MBCT in this population. METHODS: Twelve participants of the trial were interviewed about their experiences. This was done before and after the MBCT course, and 12 months later. Written evaluations of participants and notes of participant observers were used for data-triangulation. RESULTS: In total, 35 qualitative interviews were conducted. MBCT initiated a process of change, starting with awareness of the present moment, the associated sensory experiences, thoughts and emotions and accepting rather than resisting these. Participants started to recognize their own behavioral patterns and change them, thus improving self-care. Self-compassion seemed to result from and facilitate this process. Main barriers were concurrent social problems and the inability or unwillingness to accept symptoms. CONCLUSIONS: MBCT can start a process of change in patients with persistent MUS. Awareness and acceptance of painful symptoms and emotions are key factors in this process. Change of unhelpful behavioral patterns and increased self-care and self-compassion can result from this process.

Manipulative therapies for infantile colic.

BACKGROUND: Infantile colic is a common disorder, affecting around one in six families, and in 2001 was reported to cost the UK National Health Service in excess of £65 million per year (Morris 2001). Although it usually remits by six months of age, there is some evidence of longer-term sequelae for both children and parents.Manipulative therapies, such as chiropractic and osteopathy, have been suggested as interventions to reduce the severity of symptoms. OBJECTIVES: To evaluate the results of studies designed to address efficacy or effectiveness of manipulative therapies (specifically, chiropractic, osteopathy and cranial manipulation) for infantile colic in infants less than six months of age. SEARCH METHODS: We searched following databases: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 3 2012), EMBASE (1980 to 2012 Week 17), CINAHL (1938 to April 2012), PsycINFO (1806 to April 2012), Science Citation Index (1970 to April 2012), Social Science Citation Index (1970 to April 2012), Conference Proceedings Citation Index - Science (1990 to April 2012) and Conference Proceedings Citation Index - Social Science & Humanities (1970 to April 2012). We also searched all available years of LILACS, PEDro, ZETOC, WorldCat, TROVE, DART-Europe, ClinicalTrials.gov and ICTRP (May 2012), and contacted over 90 chiropractic and osteopathic institutions around the world. In addition, we searched CentreWatch, NRR Archive and UKCRN in December 2010. SELECTION CRITERIA: Randomised trials evaluating the effect of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions for the treatment of infantile colic. DATA COLLECTION AND ANALYSIS: In pairs, five of the review authors (a) assessed the eligibility of studies against the inclusion criteria, (b) extracted data from the included studies and (c) assessed the risk of bias for all included studies. Each article or study was assessed independently by two review authors. One review author entered the data into Review Manager software and the team's statistician (PP) reviewed the chosen analytical settings. MAIN RESULTS: We identified six studies for inclusion in our review, representing a total of 325 infants. There were three further studies that we could not find information about and we identified three other ongoing studies. Of the six included studies, five were suggestive of a beneficial effect and one found no evidence that manipulative therapies had any beneficial effect on the natural course of infantile colic. Tests for heterogeneity imply that there may be some underlying difference between this study and the other five.Five studies measured daily hours of crying and these data were combined, suggesting that manipulative therapies had a significant effect on infant colic - reducing average crying time by one hour and 12 minutes per day (mean difference (MD) -1.20; 95% confidence interval (CI) -1.89 to -0.51). This conclusion is sustained even when considering only studies with a low risk of selection bias (sequence generation and allocation concealment) (MD -1.24; 95% CI -2.16 to -0.33); those with a low risk of attrition bias (MD -1.95; 95% CI -2.96 to -0.94), or only those studies that have been published in the peer-reviewed literature (MD -1.01; 95% CI -1.78 to -0.24). However, when combining only those studies with a low risk of performance bias (parental 'blinding'), the improvement in daily crying hours was not statistically significant (MD -0.57; 95% CI -2.24 to 1.09).One study considered whether the reduction in crying time was clinically significant. This found that a greater proportion of parents of infants receiving a manipulative therapy reported clinically significant improvements than did parents of those receiving no treatment (reduction in crying to less than two hours: odds ratio (OR) 6.33; 95% CI 1.54 to 26.00; more than 30% reduction in crying: OR 3.70; 95% CI 1.15 to 11.86).Analysis of data from three studies that measured 'full recovery' from colic as reported by parents found that manipulative therapies did not result in significantly higher proportions of parents reporting recovery (OR 11.12; 95% CI 0.46 to 267.52).One study measured infant sleeping time and found manipulative therapy resulted in statistically significant improvement (MD 1.17; 95% CI 0.22 to 2.12).The quality of the studies was variable. There was a generally low risk of selection bias but only two of the six studies were evaluated as being at low risk of performance bias, three at low risk of detection bias and one at low risk of attrition bias.One of the studies recorded adverse events and none were encountered. However, with only a sample of 325 infants, we have too few data to reach any definitive conclusions about safety. AUTHORS' CONCLUSIONS: The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.There are inadequate data to reach any definitive conclusions about the safety of these interventions.

Is acarbose equivalent to tolbutamide as first treatment for newly diagnosed type 2 diabetes in general practice? A randomised controlled trial.

We performed a double blind randomised controlled trial in general practice to assess equivalence between tolbutamide and acarbose with respect to the effect on mean HbA(1c) in newly diagnosed patients with type 2 diabetes. Secondary objectives were to compare the effects of both treatments on fasting and post-load blood glucose and insulin levels, lipids, and adverse events. Patients were randomised to receive acarbose, titrated step-wise to a maximum of 100mg three times daily (n=48) or tolbutamide, similarly titrated to a maximum of 2000 mg in three doses (n=48). The two treatments were considered equivalent if the two-sided 90% confidence interval (CI) for the difference in mean HbA(1c) levels was within the range -0.4 to 0.4%. Results were analysed on an intention-to-treat, per-protocol and on worst-case basis. Both agents reduced the HbA(1c) percentage and fasting blood glucose levels. The difference in mean decrease of HbA(1c) was 0.6% in favour of tolbutamide (90% CI 0.3, 0.9; 95% CI 0.2, 1.0). A worst-case analysis, assuming no change in HbA(1c) for dropouts, yielded a difference in mean decrease of 0.9% (90% CI 0.6, 1.2) in favour of tolbutamide. The difference in mean decrease of fasting blood glucose was 1.0 mmol/l in favour of tolbutamide (95% CI 0.3, 1.7). There were no significant differences in post-load blood glucose, fasting and post-load insulin levels, or lipids. In the acarbose group significantly more patients (15 versus 3) discontinued therapy because of adverse effects, mostly of gastrointestinal origin. We conclude that the results of this study favour tolbutamide over acarbose as first treatment for patients with newly diagnosed type 2 diabetes.