The Caring Universities Project: EsteemUp RCT

NCT05582954 | Unknown

• 1 other identifier: VCWE-2022-135
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Esteem

Outcome Measures

Primary Outcomes (3)

• Satisfaction with the intervention

  The Client Satisfaction Questionnaire (CSQ-8) is used to measure participants' satisfaction with the overall intervention. The CSQ-8 is commonly used to measure satisfaction with online interventions. It consists of eight items on a four-point Likert scale with a total score ranging from 8 to 32, where a higher score indicates greater satisfaction.

  T1 (post test: 4-weeks)

• Treatment Adherence

  Adherence refers to "the degree to which the user followed the program as it was designed" (Donkin et al., 2011). The present study measures adherence by dividing the number of modules completed by a participant at time of post-test by the total number of modules in the programme, and multiplying this by 100. The resulting percentage will indicate completion rate.

  T1 (post test: 4-weeks)

• Satisfaction with E-coach

  The Working Alliance Inventory for guided internet interventions (WAI-I) is used to evaluate participant's satisfaction with the e-coach. The WAI-I consists of 12 items on a 5-point Likert scale with a total score ranging from 12 to 60, where higher scores indicate higher satisfaction

  T1 (post test: 4-weeks)

Secondary Outcomes (3)

• Change in self-esteem

  T0 (Baseline) to T1 (Post-test: 4-weeks)

• Change in depressive symptoms

  T0 (Baseline) to T1 (Post-test: 4-weeks)

• Change in Anxiety symptoms

  T0 (Baseline) to T1 (Post-test: 4-weeks)

Other Outcomes (3)

• Socio demographic characteristics of participants

  T0 (Baseline)

• Satisfaction with individual modules

  Module 1, Module 2, Module 3, Module 4

• Satisfaction with badges

  T1 (Post-test: 4-weeks)

Study Arms (2)

EsteemUp

EXPERIMENTAL

Participants assigned to this arm will receive a 4 week-guided e-health application - EsteemUp - to improve their self-esteem

Behavioral: EsteemUp

EsteemUp -G

ACTIVE COMPARATOR

This group will receive the same intervention (EsteemUp) with the addition of gamification elements.

Behavioral: EsteemUp; Behavioral: EsteemUp-G

Interventions

EsteemUp BEHAVIORAL

EsteemUp 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.

EsteemUp; EsteemUp -G

EsteemUp-G BEHAVIORAL

The 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

EsteemUp -G

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- None. All interested students are eligible to participate.

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Erasmus University Rotterdam: collaborator
• University of Amsterdam: collaborator
• Leiden University: collaborator
• Maastricht University: collaborator
• Utrecht University: collaborator
• InHolland University of Applied Sciences: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, 1181 HV, Netherlands

Location

Study Officials

• Pim Cuijpers, dr. Prof

  VU University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent researcher who is not involved in the study will generate the random sequence using a computer random sequence generator. Randomisation will take place at an individual level, stratified by gender and the university where students study. Participants will be randomised into two groups (EsteemUp vs EsteemUp-G) with an allocation ratio of 1:1. We will conduct block randomisation with randomly varied block sizes (6 to 12 allocations per block) to prevent foreknowledge of intervention assignment. Allocation will be concealed from the study's researchers. It is not possible to mask personnel and participants to the treatment allocation because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Model Details: 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)

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: November 3, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

NL (1)