NCT05072340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

August 11, 2021

Last Update Submit

December 24, 2024

Conditions

Keywords

Resilience trainingBlended learningRandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Resilience

    Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor \& Davidson 2003). Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience. The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue \& Cheung, 2021).

    Baseline

  • Resilience

    Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor \& Davidson 2003). Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience. The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue \& Cheung, 2021).

    After training complete

  • Resilience

    Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor \& Davidson 2003). Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience. The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue \& Cheung, 2021).

    Three months after training completes

Secondary Outcomes (6)

  • Social support

    Baseline

  • Social support

    After training completes

  • Social support

    Three months after training completes

  • Learning

    Baseline

  • Learning

    After training completes

  • +1 more secondary outcomes

Study Arms (2)

RISE (Blended learning)

EXPERIMENTAL

Students will undergo a training that comprises of six sessions: (1) introducing resilience, (2) coping strategies, (3) creating positivity, (4) shifting mindsets, (5) building social competency and (6) preparing for the future. RISE training will be hosted via the NUS' online learning platform, LumiNUS and virtual face-to-face platform, Zoom. Each session will take approximately one to two hours per week. One session is made available each week to encourage completion before moving onto the next session. Students will be provided with materials in the form of interactive videos. Virtual face-to-face sessions, online forum, quizzes and homework will be additionally available to students.

Behavioral: Resilience Skills Enhancement (RISE)

RISE (Asynchronous learning)

ACTIVE COMPARATOR

Students will also undergo a six-session training comprising of: (1) introducing resilience, (2) coping strategies, (3) creating positivity, (4) shifting mindsets, (5) building social competency and (6) preparing for the future. RISE training will be hosted via the NUS' online learning platform, LumiNUS. One session is made available each week to encourage completion before moving onto the next session. Participants will be reminded via emails and short message service (SMS) to complete the intervention. Students will be provided with materials in the form of interactive videos in LumiNUS.

Behavioral: Resilience Skills Enhancement (RISE)

Interventions

The RISE training was developed according to theory, empirical evidence and contextual information. The contents, components, pedagogy, and technical elements of RISE is established based on the resilience theory (Szanton \& Gill, 2010) systematic review and meta-analysis, meta-synthesis, and qualitative study (Ang et al., 2021). Ethical and quality standards was assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form respectively. The overall rating of the designed RISE is more than 75% of the total possible points to ensure quality of website by three research team members.

RISE (Asynchronous learning)RISE (Blended learning)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

  • Ying Lau, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The allocation was done based on the participants' sequence of enrolment, and another research assistant opened the opaque envelopes and allocated participants to either the blended or self-guided RISE group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2021

First Posted

October 8, 2021

Study Start

December 1, 2021

Primary Completion

January 31, 2022

Study Completion

December 31, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations