Goldstein 2019.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): not specified in conference abstract/poster or abstract of manuscript under review Imputation of missing data: no imputation of missing data; per‐protocol analysis (i.e. only participants who completed workshops) and available‐case analysis (i.e. only participants for whom outcomes were obtained) |
|
Participants |
Country: USA Setting: undergraduate students; training setting not specified Age: mean = 20.77 (SD = 3.36) years Sample size (randomised): 92 Sex: 36 women, 9 men (in analysed sample) Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: undergraduate students (including health profession students) Method of recruitment: not specified Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): pre‐intervention (assessment not completed): 3 (IG: 1, CG: 2); further withdrawals during workshops: 20 (IG: 9, CG: 11); post‐intervention (further lost to follow‐up): 9 (IG: 4, CG: 5); 3‐month follow‐up (further lost to follow‐up): 15 (IG: 7, CG: 8) Reasons for missing data: not specified |
|
Interventions |
Intervention: ‘Your Enlightened Side’ (YESplus) (n = 47)
Control: attention control: ‘Wisdom On Wellness’ (WOW) (n = 45)
|
|
Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention; 3) 3‐month follow‐up (3 months post‐intervention) Adverse events: not specified |
|
Notes |
Contact with authors: We contacted the authors for information on whether fostering resilience was a primary aim of the study (see miscellaneous outcomes). Since the authors gave feedback that health profession students were also included (Goldstein 2019 [pers comm]), we asked for the outcome data for this subgroup. We received no response to this inquiry. Study start/end date: not specified in conference abstract/poster or abstract of manuscript under review Funding source: research funded by a Mind and Life Institute Varela Award and National Science Foundation Graduate Research Fellowship Declaration of interest: not specified in conference abstract/poster or abstract of manuscript under review Ethical approval needed/obtained for study: not specified in conference abstract/poster or abstract of manuscript under review Comments by study authors: not relevant Miscellaneous outcomes by the review authors: conference abstract; presented at 2019 33rd Annual Meeting of the Associated Professional Sleep Societies, San Antonio, TX; manuscript under review according to authors; Information received from authors concerning study aims: “It aimed to improve well‐being, as measured by various domains including depression, anxiety, perceived stress, self‐esteem, sleep, life satisfaction, and cardiac stress metrics which could be considered correlates or potential mechanisms of resilience. Given that it was a longitudinal design focusing on students, with a 3‐month follow‐up period, we anticipated the participants to experience natural stress associated with being a student and interpret the results as reflecting increased resilience.” corresponding poster and paper of manuscript under review sent by authors Correspondence: Michael R Goldstein; Department of Psychology, Psychophysiology Research Laboratory; University of Arizona, Tucson, AZ, USA; mgoldstein@email.arizona.edu |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "89 students (age 20.9±3.1 years, 73% female, 86% undergraduate) with general distress complaints were randomly assigned to undergo one of two stress‐management workshops." Quote (paper abstract; paper under review): "In this study, students were randomized to one of two psychosocial stress‐management interventions." Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; verified baseline comparability of groups for sociodemographic characteristics (gender, age, ethnicity, race, student status, GPA; all Ps > 0.377); baseline comparability for outcome variables not specified |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, blinding of participants and personnel probably not done (face‐to‐face group intervention), but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, blinding of participants and personnel probably not done (face‐to‐face group intervention) and the outcome is likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, insufficient information about blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement: based on conference abstract, poster and paper abstract of manuscript under review, 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 | High risk | Quote: "89 students (age 20.9±3.1 years, 73% female, 86% undergraduate) with general distress complaints were randomly assigned to undergo one of two stress‐management workshops." Quote (Paper abstract of manuscript under review): "Forty‐five students completed all time‐points and were used for analysis" Judgement comment: based on conference abstract, poster and paper abstract of manuscript under review, reasons for missing data likely to be related to true outcome with imbalance in missing data between groups: (Pre‐intervention: IG: 1, CG: 2; further withdrawals during workshop: IG: 9, CG: 11; Post‐intervention (further lost to follow‐up): IG: 4, CG: 5; 3‐month follow‐up (further lost to follow‐up): IG: 7, CG: 8); per‐protocol analysis (i.e. only participants who completed workshops) and available‐case analysis (i.e. only participants for whom outcomes were obtained) |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no study protocol or trial registration available; based on conference abstract, poster and paper abstract of manuscript under review, insufficient information to permit judgement of 'Low risk' or 'High risk' |