Clinical Trials Directory

Trials / Unknown

UnknownNCT05582954

The Caring Universities Project: EsteemUp RCT

Feasibility and Acceptability of a Guided E-health Programme (EsteemUp), With and Without Gamification Elements, to Increase Self-esteem in University Students.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
356 (estimated)
Sponsor
VU University of Amsterdam · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Accepted

Summary

Within the Caring Universities project (study protocol VCWE- 2020-135 accepted by the VCWE), the investigators have developed a guided e-health programme (EsteemUp) designed to increase university students' self-esteem. With the current study, the investigators aim to examine the feasibility and acceptability of EsteemUp - with and without gamification elements - to improve students' self-esteem. Secondary goals are to gain insight into pre-test to post-test differences regarding self-esteem, symptoms of depression, anxiety and quality of life.

Detailed description

The present study is a two-armed randomized controlled trial. This trial will be conducted in a university setting. Participants will be randomized to receive a version of the intervention either with gamification elements (EsteemUp-G) or without gamification elements (EsteemUp). EsteemUp was developed based on existing literature on self-esteem and adapted in collaboration with university students to meet the specific needs of the university students. EsteemUp is based on cognitive-behavioural therapy (CBT) and consists of four modules that are delivered via computer, laptop, tablet, or mobile phone. Every module consists of evidence-based information, exercises, and homework assignments. The content is delivered in text format with pictures and infographics. The intervention is available in both English and Dutch. Participants assigned to EsteemUp-G will receive the exact same intervention explained above with an addition of gamification elements. These elements include Badges, unlockable content, a. certification of completion at the end of the program, goal setting, gamification terminology and a progress bar. Every week trained e-coaches (trained clinical psychology master students) will provide asynchronous written personalized feedback to each participant on the progress of the program and the exercises via the program platform. Measurements include post-test assessment of adherence, treatment satisfaction, and satisfaction with e-coach. Secondary outcomes include pre and post-assessment of self-esteem, common measures of psychopathology symptoms, and quality of life. Data will be analysed based on the intent-to-treat principle. All students currently enrolled at the participating universities (Vrije Universiteit Amsterdam, Erasmus University, InHolland University of Applied sciences, Universities of Amsterdam, Leiden, Utrecht and Maastricht) are potentially eligible for the trial. Students can participate in EsteemUp free of charge, which will likely increase their self-esteem and confidence. They will not receive any additional incentives for participation.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEsteemUpEsteemUp is a guided e-health application based on cognitive-behavioural therapy (CBT). It consists of four modules that take approximately 30 to 45 minutes to complete. Each module includes evidence-based psycho-education, reflection questions, interactive exercises, and homework assignments. The content is delivered both textually and visually, including the use of pictures, infographics and videos. Every week trained e-coaches (trained clinical psychology master students) will provide asynchronous written personalized feedback to each participant on the progress of the program and the exercises via the program platform.
BEHAVIORALEsteemUp-GThe gamification elements added to this arm include (1) Badges - digital rewards upon completing important milestones within the programme EsteemUp. (2) Unlockable content - downloadable worksheets of the exercises that they have done in the module, (3) A certification of completion at the end of the program, (4) Goal setting (5) Gamification terminology - All homework assignments will be framed as a 'challenge' that needs to be completed, (6) a progress bar that will indicate how far along the participant is in the program

Timeline

Start date
2022-11-03
Primary completion
2023-08-01
Completion
2023-11-01
First posted
2022-10-17
Last updated
2022-11-30

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05582954. Inclusion in this directory is not an endorsement.