Distant delivery of a mindfulness-based intervention for people with Parkinson's disease: the study protocol of a randomised pilot trial.

BACKGROUND: Psychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson's disease. Pharmacological treatments for these conditions appear relatively ineffective in Parkinson's disease. Mindfulness courses are increasingly popular and recognised as effective for managing emotional states, and there is growing evidence for the effectiveness of mindfulness courses for people with long-term medical conditions. With this exploratory pilot trial, we want to assess the feasibility of the procedures and processes, including recruitment, most appropriate outcome measure(s), acceptability of type and number of measures, potential nocebo effects, and potential effectiveness and cost-effectiveness of a specially adapted distance-delivered mindfulness-based intervention in people affected by Parkinson's disease. METHODS/DESIGN: This is a pilot two-arm randomised parallel group controlled trial. Sixty participants who meet eligibility criteria will be randomly assigned either to an 8-week mindfulness-based intervention group or a wait-list control group. The mindfulness intervention will include 1-h weekly sessions delivered by a health psychologist trained to facilitate mindfulness courses. Participants in both groups will complete standardised questionnaires assessing anxiety, depression, pain, insomnia, fatigue, and daily activities at four time points (baseline, 4, 8, and 20 weeks). The analysis will also consider potential mechanisms of change, such as acceptance, self-compassion, and tolerance of uncertainty, as well as health economic outcomes. Participants' experiences of the mindfulness interventions will be explored via in-depth interviews. DISCUSSION: A mindfulness-based intervention for people with Parkinson's delivered remotely, through Skype group videoconferences, may represent a viable, more accessible, intervention for people with mobility limitations and people who live in rural areas. The trial will provide important information about the feasibility, potential efficacy and cost-effectiveness, and acceptability of the intervention as well as mechanisms of psychosocial adjustment. The results of this pilot trial will help us design a phase III trial to assess efficacy of an online mindfulness-based intervention in Parkinson's disease and evaluate significance. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02683330.

An experience sampling study of worry and rumination in psychosis.

BACKGROUND: Increasing research effort is being dedicated to investigating the links between emotional processes and psychosis, despite the traditional demarcation between the two. Particular focus has alighted upon two specific anxious and depressive processes, worry and rumination, given the potential for links with aspects of delusions and auditory hallucinations. This study rigorously explored the nature of these links in the context of the daily life of people currently experiencing psychosis. METHOD: Experience sampling methodology (ESM) was used to assess the momentary links between worry and rumination on the one hand, and persecutory delusional ideation and auditory hallucinations on the other. Twenty-seven participants completed the 6-day experience sampling period, which required repeated self-reports on thought processes and experiences. Multilevel modelling was used to examine the links within the clustered data. RESULTS: We found that antecedent worry and rumination predicted delusional and hallucinatory experience, and the distress they elicited. Using interaction terms, we have shown that the links with momentary symptom severity were moderated by participants' trait beliefs about worry/rumination, such that they were reduced when negative beliefs about worry/rumination (meta-cognitions) were high. CONCLUSIONS: The current findings offer an ecologically valid insight into the influence of worry and rumination on the experience of psychotic symptoms, and highlight possible avenues for future intervention strategies.

Adjunctive zonisamide for treatment refractory anxiety.

The aim of the study was to assess the use of a novel anticonvulsant, zonisamide, in patients with treatment refractory anxiety. Pilot and open study of a cohort of patients with anxiety (n = 10), who were deemed partial or non-responders to anxiolytic therapy, and received adjunctive zonisamide in a naturalistic fashion. The primary outcome measures were the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impression of Severity (CGI-S) and the Clinical Global Impression of Improvement (CGI-I). Patients included were markedly ill with a mean number of previous medication trials of 4.9 +/- 1.9, a baseline HAM-A score of 27.9 +/- 3.8, and a baseline CGI-S score of 5.7 +/- 0.5. Patients improved significantly with an end-point HAM-A score of 12.6 +/- 7.4 (p < 0.001), CGI-S score of 3.6 +/- 1.3 (p < 0.002) and CGI-I score of 2.5 +/- 1.3. Zonisamide at a mean +/- SD dose of 160 +/- 70 mg/day for 9.2 +/- 4.5 weeks was generally well tolerated. Adverse events were generally mild, and no patients discontinued zonisamide because of side effects. Six patients (60%) met responder criteria at end-point (CGI-I