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. 2020 Jul 20;2020(7):CD013684. doi: 10.1002/14651858.CD013684

Samouei 2015.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Unit of randomisation: not exactly specified (based on full text unclear if individual or cluster‐randomisation)Power (power & sample size calculation, level of power achieved): not specifiedImputation of missing data: not specified
Participants Country: IranSetting: students of Isfahan University of Medical Sciences; training setting probably university (since training sessions held at same day as other university classes)Age: not specifiedSample size (randomised): not specifiedSex: not specifiedComorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified
Population description: students of Isfahan University of Medical Sciences
Method of recruitment: recruited from students of Isfahan University of Medical Sciences (Department of Management and Medical Informatics and Department of Rehabilitation Sciences); 5 study groups selected from majors of audiology, speech therapy, orthopaedics, physiotherapy, healthcare management, and medical librarianship; method of recruitment not specified
Inclusion criteria: not specified
Exclusion criteria: not specified
Attrition (withdrawals and exclusions): not specified
Reasons for missing data: not specified
Interventions Intervention: mindfulness training (n = not specified)
  • delivery: face‐to‐face group setting; teachings include: discussions, group activities, role playing, individual tasks, group tasks, homework

  • providers: teaching sessions carried out by psychology lecturer

  • duration of treatment period and timing: 8 x 2‐hour sessions once or twice a week; homework assignments; training sessions held on same day as other university classes

  • description:

    • guidelines for teaching sessions arranged using pamphlet titled: Guide for teaching basic mindfulness skills

    • During teaching sessions, participants learn different methods for connecting with their bodies, thoughts and emotions and how to concentrate on tasks and accept their bodies and emotions without judgement.

    • SESSION CONTENT: each session starts with brief description about mindfulness and the importance of living in the present; techniques thought in sessions include muscle relaxation during sessions, concentrating on present, experiencing inside and outside, thought faulting, recording 3 minutes of thoughts, mindful breathing, mindful diet, and mindfulness during mindful activities; at end of the each session: homework assignment related to the covered techniques

  • compliance: not specified

  • integrity of delivery: not specified

  • economic information: not specified

  • theoretical basis: mindfulness‐based


Control: active control (n = not specified)
  • delivery: brochures

  • providers: self‐guided

  • duration of treatment period and timing: not specified

  • description: brochures about scientific information unrelated to psychology distributed

  • compliance: not specified

  • integrity of delivery: not specified

  • economic information: not specified

  • theoretical basis: not specified

Outcomes Outcomes collected and reported:
  • mindfulness ‐ FFMQ, not reported

  • psychological capital, total score ‐ PCQ

  • psychological capital, self‐efficiency ‐ PCQ

  • psychological capital, hopefulness ‐ PCQ

  • psychological capital, resilience ‐ PCQ

  • psychological capital, optimism ‐ PCQ


Time points measured and reported: 1) pre‐intervention; 2) 3‐month follow‐up (i.e. 3 months after last session); only 2) reported
Adverse events: not specified
Notes Contact with authors: We contacted the authors for the number of participants randomised to each group. We also asked if there were any missing data (e.g. withdrawals or exclusions) in the 2 groups, the number of participants analysed, respectively, and if the study used cluster randomisation, but received no response to 2 inquiries. Study start/end date: study conducted in 2013Funding source: financial support and sponsorship: nilDeclaration of interest: There are no conflicts of interest.Ethical approval needed/obtained for study: not specifiedComments by study authors: not relevantMiscellaneous outcomes by the review authors: not relevantCorrespondence: Miss Rahele Samouei, PhD Student of Health Management in Disasters; Social Determinants of Health Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Samouei@mail.mui.ac.ir
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Therefore, cluster sampling method was employed by simultaneous selection of five groups of students from two departments to four majors whom were then randomly divided to study and control groups."
Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; no information about comparability of groups in sociodemographic characteristics or outcome variables at baseline or respective analysis
Allocation concealment (selection bias) Unclear risk Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias)
Subjective outcomes High risk Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Judgement comment: insufficient information about blinding of outcome assessment; but due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Judgement comment: insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’ (e.g. number randomised to each group not stated; unclear if there were any missing data and if missing data were imputed, for example; number of participants analysed in each group not specified)
Selective reporting (reporting bias) High risk Judgement comment: no study protocol or trial registration available, but not all of the study’s prespecified outcomes have been reported (FFMQ values at post‐intervention not reported)