Clinical trial NCT05582954: The Caring Universities Project: EsteemUp RCT
Official title: Feasibility and Acceptability of a Guided E-health Programme (EsteemUp), With and Without Gamification Elements, to Increase Self-esteem in University Students.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Esteem
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Erasmus University Rotterdam
name: University of Amsterdam
name: Leiden University
name: Maastricht University
name: Utrecht University
name: InHolland University of Applied Sciences
First posted: 2022-10-17
Enrollment: 356
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a two-armed randomized controlled trial. This trial will be conducted in a university setting. A guided web-based intervention to improve self-esteem (EsteemUp) will be compared to a version of the same intervention with gamification elements (EsteemUp-G)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

To be eligible to participate in this trial, a subject must meet all the following criteria:

* Being fluent in Dutch and/or English
* Being enrolled as a student of the seven participating universities
* Being 16 years of age or older
* Having access to a PC or mobile device with internet access
* Provide informed consent before participation

Exclusion Criteria:

- None. All interested students are eligible to participate.

Primary outcomes:
measure: Satisfaction with the intervention
timeFrame: T1 (post test: 4-weeks)
measure: Treatment Adherence
timeFrame: T1 (post test: 4-weeks)
measure: Satisfaction with E-coach
timeFrame: T1 (post test: 4-weeks)
Secondary outcomes:
measure: Change in self-esteem
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
measure: Change in depressive symptoms
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
measure: Change in Anxiety symptoms
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Other outcomes:
measure: Socio demographic characteristics of participants
timeFrame: T0 (Baseline)
measure: Satisfaction with individual modules
timeFrame: Module 1, Module 2, Module 3, Module 4
measure: Satisfaction with badges
timeFrame: T1 (Post-test: 4-weeks)
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Pim Cuijpers, dr. Prof
role: STUDY_DIRECTOR
References: