Clinical trial NCT05072340: Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students
Official title: Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students: A Sequential Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience, Psychological
Adaptation, Psychological
Keywords: Resilience training
Blended learning
Randomized controlled trial
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background University students experience high levels of stress and this may negatively impact their mental health, coping and academic outcomes. Building resilience has been described as an ability to maintain mental well-being.

Aims This study aims to (1) assess the feasibility of the Resilience Skills Enhancement (RISE) program, (2) evaluate the effects of RISE on undergraduate students' resilience, coping, emotion regulation, positive emotions and stress and (3) explore students' perception of RISE.

Methods This study will be operationalized in three phases.

Phase 1 - Feasibility A single-arm pre-post study will be used. 10 students will be recruited to explore their acceptability, perception, and suggestions for improving RISE. RISE comprises of six weekly sessions delivered via LumiNUS and Zoom. The Wilcoxon signed rank test will be used to analyse the data.

Phase 2 - Randomized controlled trial A prospective, double blind randomized controlled trial and repeated post-tests will be used. A total of 122 students will be recruited from LumiNUS and social media platforms. Participants will receive a series of six, weekly online sessions in both groups. The primary outcome is resilience. The secondary outcomes include, coping, emotion relation, positive emotions, stress. Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three time points through Wilks's lambda test. The data will be analysed according to the intention-to-treat principle.

Phase 3 - Process evaluation A qualitative study using an individual, semi-structured interviews will be used to explore students' perception of RISE. Approximately 20 students will be recruited, and the final sample size will be determined based on data saturation. Thematic analyses will be used to analyse the data.

Potential contributions This study will contribute by evaluating evidence-based user-friendly RISE that may be effective for enhancing university students' resilience.


Eligibility criteria: Inclusion Criteria:

1. Full undergraduate in NUS
2. Above 18 years old
3. Comprehend English language
4. Have access to an electronic device (laptop, smartphone or tablet)

Exclusion Criteria:

1. No self-reported history of mental health disorders
2. Did not participate in any other form of resilience training

Primary outcomes:
measure: Resilience
timeFrame: Baseline
measure: Resilience
timeFrame: After training complete
measure: Resilience
timeFrame: Three months after training completes
Secondary outcomes:
measure: Social support
timeFrame: Baseline
measure: Social support
timeFrame: After training completes
measure: Social support
timeFrame: Three months after training completes
measure: Learning
timeFrame: Baseline
measure: Learning
timeFrame: After training completes
measure: Learning
timeFrame: Three months after training completes
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Ying Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References: