Participant Enrollment, Completion, and Baseline Characteristics at T0
Figure 1A illustrates participant flow from enrollment and eligibility screening through baseline assessment and random allocation. Figure 1B illustrates the assessment schedule across baseline (T0), the 6-week intervention period, the post-intervention assessment conducted within 48 h after Week 6 (T1), and the 4-week follow-up assessment (T2). Ninety students were randomized in a 1:1:1 ratio to PME (n = 30), active-control music appreciation (n = 30), or waitlist control (n = 30). Baseline demographic characteristics, previous music training, recent 7-day major stressor status, baseline music exposure, attendance, and protocol adherence are summarized in Table 1. Baseline outcome measures are summarized in Table 2. The participant-level dataset used to generate the tables and figures is provided in Supplementary Data File 1.
The three study groups were broadly comparable at baseline. Mean age was similar across groups (PME, 20.34 ± 1.50 years; active control, 20.45 ± 1.70 years; waitlist control, 20.48 ± 1.54 years). Female participants comprised 18/30 (60.0%) of the PME group, 19/30 (63.3%) of the active-control group, and 24/30 (80.0%) of the waitlist-control group. No or minimal previous music training was reported by 18/30 (60.0%), 18/30 (60.0%), and 20/30 (66.7%) participants, respectively (Table 1). Baseline outcome measures likewise showed no marked pre-intervention differences among the groups (Table 2). PANAS positive affect scores were 29.23 ± 6.13 in the PME group, 28.17 ± 5.75 in the active-control group, and 29.13 ± 6.58 in the waitlist-control group. PANAS negative affect scores were 22.33 ± 4.33, 20.00 ± 6.58, and 21.50 ± 5.12, respectively. Mean PSS-10 scores were 18.87 ± 5.02, 19.23 ± 5.13, and 17.87 ± 4.07, whereas SCS-R scores were 77.67 ± 11.40, 74.27 ± 11.47, and 77.53 ± 13.76, respectively.
Intervention Exposure, Fidelity, and Safety During Weeks 1–6
Figure 2 illustrates the standardized 90-min PME session structure, including the grounding warm-up, rhythm circle, designated pause point, improvisation, co-creation, and structured reflection components. Intervention exposure was high in both active study arms. Mean attendance was 0.87 ± 0.09 in the PME group and 0.84 ± 0.09 in the active-control group. Protocol adherence, defined as attendance at five or more of six sessions, was achieved by 25/30 (83.3%) participants in the PME group and 23/30 (76.7%) participants in the active-control group.
Table 3 summarizes the complete 6-week implementation, fidelity, deviation, corrective-action, and safety indicators. Fidelity remained consistently high throughout the intervention. PME fidelity scores ranged from 8.92 ± 0.58 to 9.33 ± 0.44, with a 6-week mean of 9.20 ± 0.49. Active-control fidelity scores ranged from 8.86 ± 0.61 to 9.09 ± 0.66, with a corresponding mean of 8.99 ± 0.56. The designated pause point was used in 2 of 6 PME sessions (33.3%), indicating selective implementation of the reset procedure rather than routine interruption of session delivery. Implementation deviations were infrequent. No PME session met the predefined low-fidelity threshold. One active-control session (1/6; 16.7%) was classified as low fidelity because of an active-control boundary violation. Facilitator-related deviations occurred once in the PME group and twice in the active-control group, whereas participant-related deviations occurred four and five times, respectively. Corrective actions were implemented once in the PME group and twice in the active-control group. Facilitator retraining was required once in the active-control group and was not required in the PME group. No adverse events related to study participation were recorded, and no participant discontinued because of a distress event. Brief discomfort that did not require discontinuation occurred in 1/30 (3.3%) participants in both the PME and active-control groups.
Post-Intervention and Follow-Up Outcomes at T1 and T2
Table 4 summarizes outcome scores at T1 and T2, change-from-baseline values (ΔT1 = T1 − T0 and ΔT2 = T2 − T0), and T1-to-T2 attenuation estimates (ΔT2 − ΔT1). Figure 3 illustrates the change-from-baseline results for PANAS positive affect (Figure 3A), PANAS negative affect (Figure 3B), PSS-10 (Figure 3C), and SCS-R (Figure 3D). At T1, the PME group demonstrated the largest improvements across all four outcome measures. PANAS positive affect increased, whereas PANAS negative affect and PSS-10 scores decreased to a greater extent than in either comparator group. SCS-R scores likewise increased more in the PME group than in the active-control or waitlist-control groups (Table 4; Figure 3). The favorable pattern was maintained at the 4-week follow-up (T2). The PME group continued to show larger improvements from baseline than either comparator group across all outcome measures, whereas the active-control group demonstrated smaller improvements and the waitlist-control group showed minimal or inconsistent change. The T1-to-T2 attenuation analysis indicated maintenance or continued improvement in the PME group. Positive affect, perceived stress, and social connectedness continued to change in the favorable direction, while reductions in negative affect were largely maintained. By comparison, attenuation estimates were smaller in the active-control group and showed little consistent improvement in the waitlist-control group (Table 4).
Model-Based Estimates
Table 5 summarizes the predefined linear mixed-effects model contrasts comparing the PME group with the active-control and waitlist-control groups at T1 and T2. The models included fixed effects for study group, assessment time, the group × time interaction, baseline recent 7-day major stressor status, and any meaningfully imbalanced baseline covariates, together with a participant-level random intercept. Estimated marginal mean differences, 95% CIs, P values, and Hedges’ g are presented in Table 5. The model-based results were consistent with the descriptive analyses. At both T1 and T2, the PME group demonstrated higher PANAS positive affect and SCS-R scores and lower PSS-10 scores than both comparator groups. For PANAS negative affect, the PME group differed significantly from the waitlist-control group at both time points, whereas the comparison with the active-control group was not statistically significant. Standardized effect sizes generally favored the PME group and remained in the same direction at both post-intervention assessments, supporting the consistency of the observed group differences across outcome measures. Sensitivity analyses incorporating multiple imputation for missing data and session-level clustering did not alter the direction of the predefined group × time contrasts. Exploratory subgroup analyses were interpreted after false discovery rate correction.
Supplementary materials accompanying this article include the PME facilitator scripts (Supplementary File 1), active-control music library and discussion guide (Supplementary File 2), online screening questionnaire (Supplementary File 3), randomization R script (Supplementary File 4), adverse event and distress response template (Supplementary File 5), Supplementary Figures 1–2, and Supplementary Data File 1 containing the participant-level dataset used to generate the tables and figures reported in this study.
Supplementary File 1. PME facilitator scripts. Facilitator scripts for all six participatory music education (PME) sessions, including session timing, facilitator prompts, transitions, guided reflection questions, pause-point wording, and intervention fidelity checkpoints.Please click here to download this file.
Supplementary File 2. Active-control music library and discussion guide. Weekly listening themes, curated music excerpts, note-taking instructions, structured discussion prompts, and prohibited active music-making activities for the active-control condition.Please click here to download this file.
Supplementary File 3. Online screening questionnaire. Online participant screening questionnaire including eligibility criteria, availability for study attendance, previous music training, exclusion criteria, and outside-session music activity screening.Please click here to download this file.
Supplementary File 4. Randomization R script. R script for sex-stratified 1:1:1 block randomization using a block size of 6 and a random seed of 20260302.Please click here to download this file.
Supplementary File 5. Adverse event and distress response template. Safety monitoring form documenting event severity, actions taken, referrals offered, participant return status, and assessment of study relatedness.Please click here to download this file.
Supplementary Table 1. Fidelity thresholds and deviation coding. Intervention fidelity thresholds, timing criteria, deviation codes, low-fidelity definitions, and corresponding corrective actions.Please click here to download this file.
Supplementary Table 2. Variable dictionary and scoring rules. Variable names, coding conventions, questionnaire scoring procedures, reverse-scoring rules, missing-data handling, and derived change-score variables.Please click here to download this file.
Supplementary Data File 1. De-identified participant-level dataset. Long-format, de-identified participant-level dataset used for all statistical analyses and to generate the tables and figures reported in this study.Please click here to download this file.