Oman 2008.
Methods | Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): To obtain greater statistical power, the trialists focus on comparing the effects of receiving either 1 of the intervention groups against outcomes from a control group; relatively small sample size and correspondingly reduced statistical power for assessing precise changes over time, or differences in treatment effect that may be associated with covariates Imputation of missing data: OMAN 2008: not specified; intention‐to‐treat analysis according to authors, with 44 participants (i.e. including 1 participant who did not participate in assessment at post‐test); but per‐protocol analysis (without 3 who dropped out before intervention or after Session 1); SHAPIRO 2011: LOCF for missing data on several variables at post‐intervention (for 1) and 12‐month follow‐up (for 3); but also per‐protocol analysis (without 2 dropouts in MBSR before intervention) |
Participants | Country: USA Setting: undergraduates recruited from catholic university; setting of training not specified Age: range = 18 ‐ 24 years Sample size (randomised): 47 Sex: 35 women, 9 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: undergraduate students at a small private university in California (e.g. recruitment in psychology department classrooms) Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): 3 dropouts after randomisation/before intervention (MBSR: 2) or after Session 1 (EPP: 1); post‐intervention: 1 lost to follow‐up/did not complete assessment; Shapiro 2011: 12‐month follow‐up: 3 (MBSR: 1, CG: 2) with missing data on several variables Reasons for missing data: for 3 dropouts after randomisation/before intervention or after Session 1: death of a parent (n = 1 in EPP), had overextended himself (n = 1 in MBSR), no reason reported (n = 1 in MBSR); reasons for participants lost to follow‐up/with missing data in assessments (see also Shapiro 2011) not specified |
Interventions |
Intervention 1: Meditation Management of Stress – MBSR; n = 16; exchange between 2 intervention groups after randomisation due to scheduling conflicts: MBSR: n = 17)
Intervention 2: Meditation Management of Stress – Easwaran’s Eight‐Point Program (EPP; n = 16; exchange between MBSR and EPP after randomisation due to scheduling conflicts: EPP: n = 15)
2 intervention groups were combined in statistical analysis Control: wait‐list control (n = 15)
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Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (after 8‐week interventions); 3) 2‐month follow‐up (2 months post‐intervention); 4) 12‐month follow‐up (12 months post‐intervention) (only in Shapiro 2011) Adverse events: not specified |
Notes |
Contact with authors: We contacted the authors to ask for the means and SDs for the treatment group (MBSR and EPP combined) for each outcome at each time point and whether the 12‐month follow‐up had been conducted for the combined IG and not only for MBSR (as reported in Shapiro 2011). We also asked whether healthcare students were included in the final sample, but received no response to our inquiries Study start/end date: recruitment in fall 2004; exact study dates not specified Funding source: Metanexus Institute (grant: “Learning from Spiritual Examples: Measures & Intervention”), John Templeton Foundation, Academic Council of Learned Societies, Contemplative Mind in Society, Fetzer Institute, Santa Clara University Internal Grants for Research, and the Spirituality and Health Institute, Santa Clara University Declaration of interest: not specified Ethical approval needed/obtained for study: approval from the IRBs of the overall administering organisation and the university Comments by study authors: not relevant Miscellaneous outcomes by the review authors: Shapiro 2011 reported part of data of study described in Oman 2008; follow‐up study with 12‐month follow‐up; interventions MBSR and EEP analysed in combined manner in Oman 2008; unclear if psychology students were included in the study Correspondence: Dr Doug Oman, School of Public Health, University of California, 50 University Hall #7360, University of California, Berkeley, CA 94720‐7360, USA; DougOman@post.Harvard.edu; Shauna L. Shapiro, Department of Counseling Psychology, Santa Clara University, , El Camino Real, Santa Clara University, Santa Clara, CA 95053; slshapiro@scu.edu |