03 March 2016; v.1 MINDFULNESS-BASED INTERVENTIONS IN EPILEPSY AIM This review aimed to evaluate the effectiveness of mindfulness as a therapeutic intervention for people with epilepsy. METHODS Criteria for selecting studies for this review The eligibility of papers will be assessed using criteria relating to population, interventions, comparison and outcomes (PICO). Studies Randomised controlled clinical trials (RCT)s will be selected. Participants Adult patients (aged 18 years or older) with a clinical diagnosis of epilepsy will be included. Interventions Trials which solely focus on, or incorporate a Mindfulness intervention where the mindfulness data can be extracted, will be selected. As with many other mind-body interventions, Mindfulness as a therapeutic intervention is inherently varied and heterogeneous. Thus different forms, duration and frequency of Mindfulness interventions will be included (Carmody & Baer 2009). Outcome measures Perceived stress Confidence Well-being Anxiety Depression Social participation Perceived self health Quality of Life 1
Physiological outcomes e.g. blood pressure Functional outcomes Seizuere frequency; seizure duration Search methods for identification of studies Searches of electronic databases Mindfulness Research Monthly (www.mindfulexperience.org), the Database of Abstracts of Reviews of Effectiveness (DARE), the Cochrane Database of Systematic reviews, the JBI (Joanna Briggs Institute) Library of Systematic Reviews and PROSPERO, will be searched for related reviews. The following databases will be searched: The Cochrane Central Register of Controlled Trials (CENTRAL) MEDLINE EMBASE CINAHL Allied and Complementary Medicine Database (AMED) PsycINFO We will also search the reference lists of reviews and published trials identified by our searches. Developing the search Electronic databases will be searched using a strategy, which combines selected MESH terms with keywords relating to mindfulness and epilepsy. Keywords Epilepsy MBSR or MBCT Mindfulness based stress reduction Meditation Relaxation therapy Relaxation near/2 (technique* or therap*) Breathing near/2 (technique* or therap*)
03 March 2016; v.1 The search strategy will be finalised for use in MEDLINE (appendix 1) and will be amended for use in the other databases, using appropriate controlled vocabulary, Boolean operators and search symbols. Full search strategies for all databases searched will be included in the appendices of the final report/paper prepared for publication. Delimiters Language: Due to resource constraints, language will be restricted to English. Currency: 1980 2016 Research subjects: Human Data collection and analysis Selection of studies All identified material will be screened for relevance using broad inclusion criteria i.e. epilepsy and mindfulness. Where there is insufficient evidence in the title and abstract to make a decision, full-text papers will be retrieved. All relevant papers will then screened according to narrow inclusion criteria relating to study design, population, intervention and outcomes, as described above. These processes will be conducted by two reviewers who will work independently and then meet to discuss and agree the outcomes of the process; any disagreements will be resolved consensually. Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review, using standardised critical appraisal instruments i.e. the Joanna Briggs Institute s (JBI) Comparable cohort/case control studies checklist and the Newcastle-Ottawa Quality Assessment scale. Any disagreements that arise between the reviewers will be resolved through discussion. Due to the likely paucity of available evidence, no papers will be excluded on the grounds of quality. However, methodological issues will be discussed in the final report/paper and will be recorded in the evidence table. Data extraction 3
Quantitative data will be extracted from papers included in the review using a reviewspecific data extraction tool (appendix 2). Data to be extracted will include details of interventions (delivery and content), populations, study methods, and primary and secondary outcomes. Data synthesis Where possible, odds ratios and their 95% confidence intervals will be calculated from the quantitative results and pooled in statistical meta-analysis with 95% confidence intervals. Odds ratios and 95% confidence intervals are calculated for the intervention effects and logrank variances are shown as an indicator of the information content of each result, being related to the number of events or the effect size as appropriate for each measurement. Heterogeneity will be assessed using the standard Chi-square. Where statistical meta-analyses are not possible, findings are presented in narrative form. REFERENCES Carmody J, Baer RA. How long does a mindfulness-based stress reduction program need to be? A review of class contact hours and effect sizes for psychological distress. Journal of Clinical Psychology 2009;65(6):627-38.
03 March 2016; v.1 Appendix 1 MEDLINE with Full Text (OVID) search strategy 1. exp Epilepsy/ 2. exp Seizures/ 3. epilep$ 4. seizure$ 5. convuls$ 6. 1 or 2 or 3 or 4 or 5 7. exp Meditation/ 8. exp Relaxation Therapy/ 9. exp Relaxation/ 10. exp Breathing Exercises/ 11. exp Mindfulness/ 12. Mindfulness based stress reduction.mp. 13. Mindfulness based cognitive therapy.mp. 14. Mindfulness based intervention* 15. MBSR or MBCT 16. Meditation 17. Relaxation therapy 18. (Relaxation adj2 (technique* or therap*)) 19. (Breathing adj2 (technique* or therap*)) 20. 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 S16. S5 and S15 S17. S5 and S15 Limiters - Date of Publication from: 19800101-20161231; Age Related: All Adult: 19+ years; Languages: English; Human 5
Appendix 2 Data Extraction Sheet Bibliographic details Author Year Country Citation References identified from reference list yes/no If yes, please provide details: Study design Study Aim Inclusion criteria Exclusion criteria Characteristics of study sample Sample size Recruited from where? Gender Age Ethnicity Socioeconomic status Employment status Marital status Educational status Living Arrangements Other (specify) Epilepsy Definition Type Duration Age at diagnosis Number and type of medications Seizure Frequency Severity Resistant to antiepileptic drug (AED) Cognitive impairment (number of participants; severity) Affective disorders (number of participants; severity) Intervention group Control /comparison group
03 March 2016; v.1 Co-morbidities (specify) Time between diagnosis and participation in the intervention Mindfulness Intervention Definition Course content Duration & frequency Who delivered the intervention? Did they have specific training? No. of participants per group Intervention materials Intervention location Cost to participants Cost effectiveness Transport issues Family involvement Other (specify) Intervention for control group Provide details: Outcomes measurement Standardised outcomes measures (specify) Study-specific outcomes measures (provide details) Other outcomes measured (provide details) No. of data collection time points Results Intervention group Control /comparison group Limitations noted by the authors Authors recommendations Authors conclusions 7
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