Follow-up outcomes of Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic, treatment-resistant depression.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) is an evidence-based treatment for depression. The current study focused on the long-term outcomes of MBCT for chronically, treatment-resistant depressed patients during a 6-months follow-up period. Additionally, predictors of treatment outcomes were explored. METHOD: The outcomes of MBCT on depressive symptoms, remission rates, quality of life, rumination, mindfulness skills and self-compassion were investigated in a cohort of chronically, treatment-resistant depressed outpatients (N = 106), who had taken part in an RCT comparing MBCT with treatment-as-usual (TAU). Measures were assessed pre-MBCT, post-MBCT, at 3-months follow-up, and at 6-months follow-up. RESULTS: Results of linear mixed effect models and Bayesian repeated measures ANOVA's reveal that depressive symptoms, quality of life, rumination, mindfulness skills and self-compassion consolidated during follow-up. Remission rates even further increased over the course of follow-up. When controlling for symptoms at baseline, higher baseline levels of rumination predicted lower depressive symptoms and quality of life at 6-month follow-up. No other predictors (i.e. duration of current depressive episode, level of treatment-resistance, childhood trauma, mindfulness skills, self-compassion) were found. LIMITATIONS: All participants received MBCT, therefore time or other non-specific effects might have influenced the results and replication studies including a control conditions are needed. CONCLUSIONS: Results indicate that the clinical benefits of MBCT for chronically, treatment-resistant depressed patients persist up to 6 months after completing MBCT. Duration of the current episode, level of treatment-resistance, childhood trauma and baseline levels of mindfulness skills and self-compassion did not predict treatment outcome. When controlling for baseline depressive symptoms participants with high levels of rumination seem to benefit more; however more research is needed. TRIAL REGISTRY: Dutch Trial Registry, number NTR4843.

Mindfulness-based cognitive therapy v. treatment as usual in adults with ADHD: a multicentre, single-blind, randomised controlled trial.

BACKGROUND: There is a high need for evidence-based psychosocial treatments for adult attention-deficit hyperactivity disorder (ADHD) to offer alongside treatment as usual (TAU). Mindfulness-based cognitive therapy (MBCT) is a promising psychosocial treatment. This trial investigated the efficacy of MBCT + TAU v. TAU in reducing core symptoms in adults with ADHD. METHODS: A multicentre, single-blind, randomised controlled trial (ClinicalTrials.gov: NCT02463396). Participants were randomly assigned to MBCT + TAU (n = 60), an 8-weekly group therapy including meditation exercises, psychoeducation and group discussions, or TAU only (n = 60), which reflected usual treatment in the Netherlands and included pharmacotherapy and/or psychoeducation. Primary outcome was ADHD symptoms rated by blinded clinicians. Secondary outcomes included self-reported ADHD symptoms, executive functioning, mindfulness skills, self-compassion, positive mental health and general functioning. Outcomes were assessed at baseline, post-treatment, 3- and 6-month follow-up. Post-treatment effects at group and individual level, and follow-up effects were examined. RESULTS: In MBCT + TAU patients, a significant reduction of clinician-rated ADHD symptoms was found at post-treatment [M difference = -3.44 (-5.75, -1.11), p = 0.004, d = 0.41]. This effect was maintained until 6-month follow-up. More MBCT + TAU (27%) than TAU participants (4%) showed a ⩾30% reduction of ADHD symptoms (p = 0.001). MBCT + TAU patients compared with TAU patients also reported significant improvements in ADHD symptoms, mindfulness skills, self-compassion and positive mental health at post-treatment, which were maintained until 6-month follow-up. Although patients in MBCT + TAU compared with TAU reported no improvement in executive functioning at post-treatment, they did report improvement at 6-month follow-up. CONCLUSIONS: MBCT might be a valuable treatment option alongside TAU for adult ADHD aimed at alleviating symptoms.

Minimizing nocebo effects by conditioning with verbal suggestion: A randomized clinical trial in healthy humans.

Nocebo effects, i.e., adverse treatment effects which are induced by patients' expectations, are known to contribute to the experience of physical symptoms such as pain and itch. A better understanding of how to minimize nocebo responses might eventually contribute to enhanced treatment effects. However, little is known about how to reduce nocebo effects. In the current randomized controlled study, we tested whether nocebo effects can be minimized by positive expectation induction with respect to electrical and histaminic itch stimuli. First, negative expectations about electrical itch stimuli were induced by verbal suggestion and conditioning (part 1: induction of nocebo effect). Second, participants were randomized to either the experimental group or one of the control groups (part 2: reversing nocebo effect). In the experimental group, positive expectations were induced by conditioning with verbal suggestion. In the control groups either the negative expectation induction was continued or an extinction procedure was applied. Afterwards, a histamine application test was conducted. Positive expectation induction resulted in a significantly smaller nocebo effect in comparison with both control groups. Mean change itch NRS scores showed that the nocebo effect was even reversed, indicating a placebo effect. Comparable effects were also found for histamine application. This study is the first to demonstrate that nocebo effects can be minimized and even reversed by conditioning with verbal suggestion. The results of the current study indicate that learning via counterconditioning and verbal suggestion represents a promising strategy for diminishing nocebo responses.

Teacher Competence in Mindfulness-Based Cognitive Therapy for Depression and Its Relation to Treatment Outcome.

As mindfulness-based cognitive therapy (MBCT) becomes an increasingly mainstream approach for recurrent depression, there is a growing need for practitioners who are able to teach MBCT. The requirements for being competent as a mindfulness-based teacher include personal meditation practice and at least a year of additional professional training. This study is the first to investigate the relationship between MBCT teacher competence and several key dimensions of MBCT treatment outcomes. Patients with recurrent depression in remission (N = 241) participated in a multi-centre trial of MBCT, provided by 15 teachers. Teacher competence was assessed using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) based on two to four randomly selected video-recorded sessions of each of the 15 teachers, evaluated by 16 trained assessors. Results showed that teacher competence was not significantly associated with adherence (number of MBCT sessions attended), possible mechanisms of change (rumination, cognitive reactivity, mindfulness, and self-compassion), or key outcomes (depressive symptoms at post treatment and depressive relapse/recurrence during the 15-month follow-up). Thus, findings from the current study indicate no robust effects of teacher competence, as measured by the MBI:TAC, on possible mediators and outcome variables in MBCT for recurrent depression. Possible explanations are the standardized delivery of MBCT, the strong emphasis on self-reliance within the MBCT learning process, the importance of participant-related factors, the difficulties in assessing teacher competence, the absence of main treatment effects in terms of reducing depressive symptoms, and the relatively small selection of videotapes. Further work is required to systematically investigate these explanations.

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.

Inducing Expectations for Health: Effects of Verbal Suggestion and Imagery on Pain, Itch, and Fatigue as Indicators of Physical Sensitivity.

UNLABELLED: Research into placebo effects has convincingly shown that inducing positive outcome expectations can reduce pain and other physical sensations. However, the comparative effects of different expectation inductions, such as verbal suggestion or mental imagery, and their generic effects on physical sensitivity, to different sensations such as pain, itch, and fatigue, are still largely unknown. In the current study, we assessed the individual and combined effects of verbal suggestion and imagery on pain, itch, and fatigue as indicators of physical sensitivity in a randomized study design. Healthy participants (n = 116) were given an inert (placebo) capsule that was said to be effective for reducing physical sensitivity in either the majority (positive verbal suggestion) or the minority (control verbal suggestion) of users. Subsequently, they imagined either their best possible health (positive imagery) or a typical day (control imagery). Sensitivity to pain, itch, and fatigue was tested using a cold pressor test, histamine iontophoresis, and a bicycle test, respectively. Heart rate and skin conductance were recorded continuously. Results showed that positive verbal suggestion and imagery successfully induced positive expectations, but they did not affect physical sensitivity, as indicated by sensitivity to pain, itch, or fatigue, or concurrent physiological responses. These results could indicate that the specificity and concreteness of expectation inductions might be important for their applicability in the treatment of physical symptoms. TRIAL REGISTRATION: Nederlands Trial Register NTR3641.

Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. Our aim was to investigate whether the addition of MBCT to mADM is a more effective prevention strategy than mADM alone. METHODS: This study is one of two multicenter randomised trials comparing the combination of MBCT and mADM to either intervention on its own. In the current trial, recurrently depressed patients in remission who had been using mADM for 6 months or longer (n=68), were randomly allocated to either MBCT+mADM (n=33) or mADM alone (n=35). Primary outcome was depressive relapse/recurrence within 15 months. Key secondary outcomes were time to relapse/recurrence and depression severity. Analyses were based on intention-to-treat. RESULTS: There were no significant differences between the groups on any of the outcome measures. LIMITATIONS: The current study included patients who had recovered from depression with mADM and who preferred the certainty of continuing medication to the possibility of participating in MBCT. Lower expectations of mindfulness in the current trial, compared with the parallel trial, may have caused selection bias. In addition, recruitment was hampered by the increasing availability of MBCT in the Netherlands, and even about a quarter of participants included in the trial who were allocated to the control group chose to get MBCT elsewhere. CONCLUSIONS: For this selection of recurrently depressed patients in remission and using mADM for 6 months or longer, MBCT did not further reduce their risk for relapse/recurrence or their (residual) depressive symptoms.

LONG-TERM OUTCOME OF MINDFULNESS-BASED COGNITIVE THERAPY IN RECURRENTLY DEPRESSED PATIENTS WITH AND WITHOUT A DEPRESSIVE EPISODE AT BASELINE.

BACKGROUND: In a previous randomized controlled trial in patients with three or more previous depressive episodes, mindfulness-based cognitive therapy (MBCT) appeared to be equally effective in those who were depressed and those who were in remission at the start of the trial. AIM: The aim of this study is to compare the 1-year outcome of MBCT in 124 remitted and 58 depressed patients who participated in the original trial and who were all offered MBCT either immediately or after a waiting period of 3 months. METHODS: The course of depressive symptoms, rumination, mindfulness skills, and quality of life over the course of treatment and the 1-year follow-up period was analyzed. Linear mixed modeling was used to compare the outcome between remitted and depressed patients at baseline. RESULTS: In the whole sample, levels of depression and rumination decreased and mindfulness and quality of life increased over treatment. Levels of depressive symptoms, mindfulness, and quality of life remained stable over the 1-year follow-up period. Rumination further decreased. Remitted and depressed patients at the start of the trial did not differ in terms of outcome during or after treatment. CONCLUSIONS: Long-term outcome after MBCT in depressed patients was comparable to those who were in remission at the start of the trial. These findings lend further support to the notion that recurrent depressed patients meeting the criteria of a depressive episode do not need to be excluded from MBCT.

Role of conditioning and verbal suggestion in placebo and nocebo effects on itch.

Placebo and nocebo effects are known to play a key role in treatment effects in a wide variety of conditions. These effects have frequently been investigated with regard to pain and also in other physical sensations, but have hardly been investigated with regard to itch. In addition, neither in pain nor in any other physical sensation, the single and combined contribution of the expectancy mechanisms of conditioning and verbal suggestion have ever been investigated in both placebo and nocebo effects within one design. For the first time, the role of verbal suggestion and conditioning in placebo and nocebo effects on itch was experimentally investigated. Expectations about itch stimuli were induced in healthy subjects by verbal suggestion, conditioning, or a combination of both procedures, and compared with a control group without expectation induction. Itch was induced electrically by means of quantitative sensory testing. Significant placebo and nocebo effects were induced in the group in which combined procedures of conditioning and verbal suggestion were applied in comparison with the control group. The conditioning and verbal suggestion procedures applied individually did not induce significant placebo and nocebo effects when compared with the control group. The results of this study extend existing evidence on different physical sensations, like pain, by showing that also for itch, the combination of conditioning and verbal suggestion is most promising in inducing both placebo and nocebo effects. More research on placebo and nocebo effects at a perceptive and neurobiological level is warranted to further elucidate the common and specific mechanisms underlying placebo and nocebo effects on itch and other physical sensations.

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

BACKGROUND: Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. METHODS/DESIGN: A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. DISCUSSION: This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study.

BACKGROUND: Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT? METHODS/DESIGN: Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio. DISCUSSION: Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00928980.