Background
Methods
Protocol
Selection criteria
Population | 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 [45]. |
Comparator | Usual care or any active comparator |
Outcome measures | Confidence |
Well-being | |
Anxiety depression | |
Social participation | |
Perceived self-health | |
Quality of Life | |
Physiological outcomes e.g., blood pressure | |
Seizure frequency; seizure duration |
Search strategy
Selection of papers for inclusion
Data extraction
Data synthesis
Results
Thompson et al. (2010) [34] | Thompson et al. (2015) [35] | Tang et al. (2015) [36] | ||||
---|---|---|---|---|---|---|
Intervention | Control | Intervention | Control | Intervention | Control | |
Number of Participants | 26 | 27 | 62 | 56 | 30 | 30 |
Number of participants (% female) | 20 (77%) | 23 (85%) | -- (65.3%) | 16 (53.3%) | 16 (53.3%) | |
Mean age (SD) | 36.4 years | 35.4 years | 41.2 years | 34.77 years (10.26) | 35.47 years (11.22) | |
Ethnicity | 20 (77%) White 6 (23%) African American | 19 (70%) White 7 (26%) African American 1 (4%) Other | 70 (59.3%) Caucasian 14 (11.9%) African American 3 (2.5%) Hispanic 6 (5.1%) Other race | NR | NR | |
Socio-economic status | NR | NR | NR | NR | NR | |
Employment status | 12 (52%) Not working/retired 7 (30%) Full Time 3 (13%) Part Time 1 (4%) Student | 12 (50%) Not working/retired 6 (25%) Full Time 3 (13%) Part Time 3 (13%) Student | NR | 56.7% Full Time | 53.3% Full Time | |
Educational status | 7 (30%) High School or less 6 (26%) Completed some college 9 (39%) Graduated college or more | 6 (25%) High School or less 9 (38%) Completed some college 9 (38%) Graduated college or more | NR | 76.7% (>11 years of education) | 80% (>11 years of education) | |
Living arrangement | 17 (74%) Immediate Family 3 (13%) Alone 2 (9%) Friend/roommate/partner | 16 (67%) Immediate family 2 (8%) Alone 6 (25%) Friend/roommate/partner | NR | NR | NR | |
Medications | 9 (39%) Antidepressants | 9 (37%) Antidepressants | 30.5% Antidepressants | 50% Carbamazepine 30% Valproate 30% Levetiracetam 26.7% Lamotrigine | 40% Carbamazepine 36.7% Valproate 26.7% Levetiracetam 26.7% Lamotrigine | |
Co-morbidities | 10 (44%) MDD | 9 (38%) MDD | NR | 3 (10%) Concomitant Psychiatric Illness 5 (16.7%) Concomitant Non-Psychiatric Illness | 2 (6.7%) Concomitant Psychiatric Illness 5 (16.7%) Concomitant Non-Psychiatric Illness | |
Mood and Quality of Life Baseline Measures | ||||||
mBDI | 31.1 | 27.9 | 20.3 | 20.2 | N/A | N/A |
BDI | 15.2 | 12.4 | 7.3 | 7.2 | N/A | N/A |
NDDI-E | N/A | N/A | 13.1 | 13.0 | N/A | N/A |
PHQ-9 | N/R | N/R | 6.7 | 5.8 | N/A | N/A |
QOLIE-31-P | N/A | N/A | N/A | N/A | 57.14 | 59.34 |
BAI | N/A | N/A | N/A | N/A | 15.10 | 13.53 |
BDI-II | N/A | N/A | N/A | N/A | 12.43 | 13.53 |
Design/aims of the studies
Mindfulness interventions
Study | Country | Follow-up Period | Intervention |
---|---|---|---|
Thompson et al. (2010) [34] | USA | 8 weeks | • Based on Mindfulness-Based Cognitive Therapy • Hour long sessions for eight weeks • Delivered via telephone or internet • Groups of six to eight participants • Facilitated by layperson with epilepsy and Master of Public Health Student Research Assistant – supervised by a licensed clinical psychologist. Mindfulness teaching certification/experience level not clear. • Sessions consisted of: check-in, instruction (video instruction – internet) skill building, discussion, homework assignment • Course content: attention to breath, sights and sounds; other meditations; body scan; progressive muscular relaxation; thought monitoring, identifying cognitive distortions, self-esteem, problem identification, goal-setting, identifying supports. • All participants had access to session materials and CD of relaxation and meditation exercises. Internet participants had access to online discussion forums. • Homework assignments given including monitoring thoughts, changing thoughts, practicing relaxation exercises, meditation exercises and mindfulness. Duration not specified. |
Thompson et al. (2015) [35] | USA | 10 weeks | • Based on Mindfulness-Based Cognitive Therapy, was script-based • Hour long sessions for eight weeks • Delivered via telephone or internet • 22 groups of up to seven participants • Facilitated by an adult with epilepsy and a graduate student with Mental Health Concentration in Public Health. Supervised by a licensed clinical psychologist and Associate Professor of Behavioural Sciences. Mindfulness teaching certification/experience level not clear, however four hours of training provided • Sessions consisted of: check-in period, teaching on topic of that week’s session, group discussion, skill-building exercise, homework assignment • Course content: knowledge about depression; monitoring and challenging, and changing thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; importance of reinforcement; preventing relapse. • Internet participants had access to archive of sessions and a discussion board. • Homework assignments given, duration not specified |
Tang et al. (2015) [36] | China (Hong Kong) | 6 weeks | • Mindfulness Therapy (experiential, progressive training on mindfulness techniques) plus social support • Four 2.5 hour bi-weekly sessions • Delivered in person • Groups of seven to eight participants • Facilitated by clinical psychologist. Mindfulness teaching certification/experience level not clear. • Course content: Knowledge and management of epilepsy; mind-body connection; Mindful breathing, eating, listening, observing; body scan; non-judgemental attitude, variation of thoughts, thought labelling. • All participants received an educational package on basic knowledge and management of epilepsy • 45 minutes of daily mindfulness practice encouraged. Homework assignments included recording thoughts and bodily sensation associated with recurrent seizure attack |
Delivery
Content
Intervention materials
Control group treatment
Outcomes
Data collection
Author (Year) | Main outcomes | Main findings |
---|---|---|
Thompson et al. (2010) [34] | Depressive Symptoms (Beck Depression Inventory and Modified form) Self-Efficacy (Depression Self-Efficacy Scale DCSES) Satisfaction with life (Satisfaction With Life Scale SWLS) Quality of Life (Behavioural Risk Factor Surveillance System BRFSS) Self-Compassion (Self-Compassion Scale SCS) Knowledge and Skills assessment | Decrease in depressive symptoms among intervention group significantly better than control, and greater for those attending more sessions. No statistical difference in efficacy in relation to presence of MDD. Telephone group results slightly better than internet group but not significant. Intervention group increased knowledge and skills more than control group; and increases were greater among those who attended more sessions. Change in knowledge and skills were negatively correlated with change in BDI score. Change in Satisfaction with Life approached significance. No significant improvement in physical and mental health QOL measures, but improvement greater in intervention group. |
Thompson et al. (2015) [35] | Depressive Symptoms (Beck Depression Inventory and Modified form; Neurological Disorders Depression Inventory for Epilepsy NDDI-E; PHQ-9) Depression Coping Self-Efficacy (Depression Coping Self-Efficacy Scale DCSES) Self-Compassion (Self-Compassion Scale SCS) Satisfaction with Life (Satisfaction With Life Scale SWLS) Quality of Life (Behavioural Risk Factor Surveillance System) Knowledge and Skills assessment | Depressive symptoms – no difference between telephone and internet groups. Significant improvement in intervention group and had less depressive episodes. Association between scores and number of sessions attended. Knowledge and skills improvements greater in intervention group, and associated with number of sessions attended. Changes significantly associated with change in mBDI scores. Knowledge and skills mediated change in mBDI scores between intervention and controls. Satisfaction with life increased in intervention group, and associated with number of sessions attended. Changes in Depression Coping Self Efficacy and Physical and Mental Health Quality of Life and Self-Compassion not significant. |
Tang et al. (2015) [36] | Quality of Life (Patient-Weighted Quality of Life in Epilepsy Inventory QOLIE-31-P) Depressive Symptoms (Beck Depression Inventory-II, BDI-II) Anxiety Symptoms (Beck Anxiety Inventory, BAI) | Control and intervention group statistically significant improvement in quality of life and anxiety scores. Improvements statistically significantly better in intervention group. Statistically significant reduction in BDI-II scores in both groups, not clinically significant. Significant reduction in seizure frequency and severity in both groups. Significant improvement in verbal and non-verbal memory. No other differences in Cognitive Functioning. |
Epilepsy measures
Depression
Anxiety
Quality of Life measures
Knowledge and Skills
Cognitive functioning
Quality appraisal
Thompson et al. (2010) [34] | Thompson et al. (2015) [35] | Tang et al. (2015) [36] | ||||
---|---|---|---|---|---|---|
Entry | Judgement | Support for judgement | Judgement | Support for judgement | Judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear Risk | Quote: “Using a stratified randomized, crossover design we randomly assigned participants to one of four strata.” Randomisation method is not described | Unclear Risk | Quote: “Using a stratified randomized, crossover design we randomly assigned participants to one of four strata.” Randomisation procedure not described | Low Risk | Quote: “Simple randomization by drawing was performed within each block to assign patients to one of the groups alternatively” Random allocation |
Allocation concealment (selection bias) | Unclear Risk | Unclear whether participants/assessors could have been aware of allocation to intervention/control in advance | High Risk | Quote: “…within each condition, people who required a particular mode of delivery (web or telephone) were placed in that group and the remainder (the majority of participants) were assigned to equalise the groups.” Not described, appears patients were allocated to different interventions (web or telephone) based on preference/need | Unclear Risk | Quote: “randomization was performed by an independent research assistant” Randomization performed by independent research assistant but method of concealment not explained. |
Blinding of participants and personnel (performance bias) | High Risk | Quote: “Neither the participants nor the project staff were blinded to the group assignment.” Clearly stated in paper under 2.5.3 Recruitment that neither were blinded | High Risk | Not described, and as above participants could choose to receive telephone or web delivery. | Low Risk | Quote: “A team of trained research assistants…who were blinded to participants’ intervention group performed all assessments…” The assessors were blinded to the patient’s intervention grouping. |
Blinding of outcome assessment (detection bias) | High Risk | Quote: “Neither the participants nor the project staff were blinded to the group assignment.” Clearly stated in paper under 2.5.3 Recruitment that neither were blinded | Unclear Risk | Not described | Low Risk | Quote: “…team of trained research assistants with a bachelor’s degree in psychology who were blinded to participants’ intervention group performed all assessments; they were separated into 2 teams, one for baseline assessment and the other for post intervention assessment.” |
Incomplete outcome data addressed (attrition bias) | High Risk | Due to repeated measures design only participants completing interim assessments were included in analyses. 13 participants left the study, not clear if control or intervention. Missing data not described | Unclear Risk | Attrition poorly characterised. Attendance poorly described including reasons for not attending. Missing values were imputed, but levels of missing values were not described. However intention-to-treat analysis carried out according to participants’ original treatment assignment. | Low Risk | Missing outcome data balanced in numbers across intervention groups. |
Selective reporting (reporting bias | Unclear Risk | All outcomes appear to have been reported, however no protocol. | Unclear Risk | Primary outcome not defined and poor discussion of four of six main outcomes (DCSE, SC, Physical and mental health QoL). No protocol. | Low Risk | Full study protocol is available |
Other Bias | Unclear Risk | Unclear Risk | Low Risk | No other sources of bias |