Sahranavard 2018.
Study characteristics | ||
Methods | Study design: RCTStudy grouping: parallel groupUnit of randomisation: individualsPower (power & sample size calculation, level of power achieved): power achieved in 1‐way covariate analysis in MANCOVA (multivariate analysis of covariance) indicates adequacy of sample size (anxiety sensitivity: 0.97; hope: 0.82; positive and negative affect: 0.57; anxiety: 1.00; hardiness: 0.82; self‐efficacy: 0.92)Imputation of missing data: not specified | |
Participants |
Country: Iran
Setting: female students from Birjand University of Medical Science; training setting not specified
Age: mean = 22.00 (SD = 1.11); range = 20 ‐ 24 years
Sample size (randomised): 30
Sex: 30 women
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: anxiety symptoms (BAI): IG: 13.40 (6.16); CG: 13.46 (5.16) Population description: female medical students of Birjand University of Medical Sciences Method of recruitment: recruited at Birjand University of Medical Sciences in Iran; method of recruitment not specified (selected by available sampling) Inclusion criteria: 1) having the BDI score higher than 16; 2) living in the dormitory; and 3) being informed and satisfied; according to Sahranavard 2018, also participants with higher than average score on the BAI Exclusion criteria: 1) unsatisfied students; 2) being graduates; 3) those who did not live in the dormitory; and 4) having BDI < 16; according to Sahranavard 2018, also students with lower than average score on the BAI Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified |
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Interventions |
Intervention: stress‐management‐based cognitive‐behavioural group treatment (n = 15)
Control: wait‐list control (n = 15) |
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Outcomes |
Outcomes collected and reported:
Depression (BDI) no outcome measure, but only assessed at baseline Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (1 week after training) Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors for any withdrawals/exclusions from the study and the number of participants analysed. We also asked for the post‐intervention means and SDs for positive and negative affect separately and whether the CBT group included 6 or 10 sessions. We received no response to 2 inquiries Study start/end date: not specifiedFunding source: no specific funding for this work; nil financial support and sponsorshipDeclaration of interest: no conflicts of interest disclosedEthical approval needed/obtained for study: approved by the Research Ethics Committee of the Birjand University of Medical Sciences (Birjand, Iran)Comments by study authors: not relevant Miscellaneous outcomes by the review authors:Sahranavard 2018 and Sahranavard 2019 are 2 reports of the same study (n = 30 randomised) with different outcomes reportedCorrespondence: Dr Sara Sahranavard; Department of Psychology, Faculty of Medicine, Birjand University of Medical Science; Social Determinants of Health Research Center, Faculty of Health, Birjand University of Medical Sciences, Tehran, Iran; sahranavard_sara@yahoo.com; alesaleh70@yahoo.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A sample of 30 participants were selected through the available sampling method and randomly assigned into experimental (CBT) and control groups (each group, 15 female student)." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; verified baseline comparability of groups for sociodemographic characteristic age (unclear for other sociodemographic variables); baseline comparability for outcome variables unclear (i.e. statistical significance not specified) |
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’ (n = 15 randomised to each group; but unclear if there were any missing data or if potential missing data were imputed; number of participants analysed in each group not stated) |
Selective reporting (reporting bias) | Low risk | Judgement comment: no study protocol or trial registration available but it is clear that the published reports include all expected outcomes, including those that were prespecified |