Mindfulness-based cognitive therapy (MBCT) for multiple chemical sensitivity (MCS): Results from a randomized controlled trial with 1 year follow-up.

OBJECTIVE: Multiple chemical sensitivity (MCS) is a medically unexplained condition characterized by symptoms from multiple organ systems following the perception of common odorants. The condition can cause severe functional impairment for afflicted individuals. The aim of this study was to assess the effects of mindfulness-based cognitive therapy (MBCT) for individuals with MCS. METHODS: The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and Sensitivity Inventory (QEESI), which measures the following aspects of MCS: impact of MCS on daily life, symptoms, and reactions following chemical exposures. Secondary outcome measures included the Brief Illness Perception Questionnaire (BIPQ) and the anxiety and depression subscales of the symptom checklist 92 (SCL-92). Participants were assessed at baseline and post treatment, and at follow-up periods of 6- and 12-months. RESULTS: We found no effect of MBCT on the primary outcome, nor did we find an effect on levels of depression or anxiety. We did, however, find positive changes in illness perceptions, which were sustained at 12-month follow-up. Dropout rates were low, suggesting MBCT was well received and regarded as an acceptable intervention by individuals with MCS. CONCLUSIONS: Overall, these results suggest that MBCT does not change overall illness status in individuals with MCS, but that MBCT positively changes emotional and cognitive representations. Possible explanations for these results are discussed.

Effect of mindfulness-based stress reduction on somatic symptoms, distress, mindfulness and spiritual wellbeing in women with breast cancer: Results of a randomized controlled trial.

BACKGROUND: Women with breast cancer experience different symptoms related to surgical or adjuvant therapy. Previous findings and theoretical models of mind-body interactions suggest that psychological wellbeing, i.e. levels of distress, influence the subjective evaluation of symptoms, which influences or determines functioning. The eight-week mindfulness-based stress reduction (MBSR) program significantly reduced anxiety and depression in breast cancer patients in a randomized controlled trial (NCT00990977). In this study we tested the effect of MBSR on the burden of breast cancer related somatic symptoms, distress, mindfulness and spiritual wellbeing and evaluated possible effect modification by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing. MATERIAL AND METHODS: A population-based sample of 336 women Danish women operated for breast cancer stages I-III were randomized to MBSR or usual care and were followed up for somatic symptoms, distress, mindfulness skills and spiritual wellbeing post-intervention and after six and 12 months. Effect was tested by general linear regression models post-intervention, and after six and 12 months follow-up and by mixed effects models for repeated measures of continuous outcomes. Effect size (Cohen's d) was calculated to explore clinical significance of effects among intervention group. Finally, modification of effect of MBSR on burden of somatic symptoms after 12 months' follow-up by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing were estimated. RESULTS: General linear regression showed a significant effect of MBSR on the burden of somatic symptoms post-intervention and after 6 months' follow-up. After 12 months' follow-up, no significant effect of MBSR on the burden of somatic symptoms was found in mixed effect models. A statistically significant effect of MBSR on distress was found at all time-points and in the mixed effect models. Significant effects on mindfulness were seen after six and 12 months and no significant effect was observed for spiritual wellbeing. No significant modification of MBSR effect on somatic symptom burden was identified. CONCLUSION: This first report from a randomized clinical trial on the long-term effect of MBSR finds an effect on somatic symptom burden related to breast cancer after six but not 12 months follow-up providing support for MBSR in this patient group.

Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer.

INTRODUCTION: As the incidence of and survival from breast cancer continue to raise, interventions to reduce anxiety and depression before, during and after treatment are needed. Previous studies have reported positive effects of a structured 8-week group mindfulness-based stress reduction program (MBSR) among patients with cancer and other conditions. PURPOSE: To test the effect of such a programme on anxiety and depression among women with breast cancer in a population-based randomised controlled study. METHODS: A total of 336 women who had been operated on for breast cancer (stage I-III) were randomised to usual care or MBSR+usual care. Questionnaires including the Symptom Checklist-90r anxiety and depression subscales and the Center for Epidemiological Studies-Depression scale were administered before randomisation and immediately, 6 and 12 months after the intervention. RESULTS: Intention-to-treat analyses showed differences between groups in levels of anxiety (p=0.0002) and depression (SCL-90r, p<0.0001; CES-D, p=0.0367) after 12 months. Graphical comparisons of participants with higher levels of anxiety and depression at baseline showed a significantly greater decrease in the intervention group throughout follow-up and no differences among least affected participants. Medium-to-large effects were found for all outcomes in the intervention group in analyses of change scores after 12 months' follow-up. CONCLUSION: The 8-week group based MBSR intervention had clinically meaningful, statistically significant effects on depression and anxiety after 12 months' follow-up, and medium-to-large effect sizes. Our findings support the dissemination of MBSR among women with breast cancer. (Clintrials.gov No.: NCT00990977).

Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer? A study of factors associated with enrollment among Danish breast cancer patients.

BACKGROUND: Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment. METHODS: We used Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR. RESULTS: Participants (N = 336) were found to be younger (p < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co-morbidity was significantly different. Self-reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure. CONCLUSION: Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness-based interventions.

Treating panic symptoms within everyday clinical settings: the feasibility of a group cognitive behavioural intervention.

Panic disorder is a common and debilitating disorder that has a prevalence rate of 3-5% in the general population. Cognitive-behavioural interventions have been shown to be an efficacious treatment for panic, although a limited number of studies have examined the effectiveness of such interventions implemented in everyday clinical settings. The aim of the following pilot study was to examine the feasibility of a brief group cognitive-behavioural intervention carried out in a clinical setting. Salient issues in determining feasibility include: representativeness of patient group treated, amount of significant clinical change displayed and resources required to carry out the intervention. A small sample of GP-referred patients displaying panic symptoms completed a 2-week intensive cognitive-behavioural intervention. Results collected post-intervention revealed significant clinical reductions in panic, anxiety and depressive symptoms and marked improvement in mobility. These improvements were maintained at 12-month follow-up. Outcomes supported the feasibility of a brief group cognitive-behavioural intervention for GP-referred patients. Implications of these results are discussed in terms of implementing effective treatments in everyday clinical practice and developing a stepped care approach to treating panic symptoms.