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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Self Esteem
• Intervention / Treatment: Behavioral: EsteemUp; Behavioral: EsteemUp-G

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.

• Study Type: Interventional
• Enrollment (Anticipated): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1181 HV
    • Vrije Universiteit Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EsteemUp; Participants assigned to this arm will receive a 4 week-guided e-health application - EsteemUp - to improve their self-esteem	Behavioral: EsteemUp; 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.
Active Comparator: EsteemUp -G; This group will receive the same intervention (EsteemUp) with the addition of gamification elements.	Behavioral: EsteemUp; 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.; Behavioral: EsteemUp-G; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-esteem	The Rosenberg Self-Esteem Scale (RSS) is used to measure explicit self-esteem. This tool consists of 10 items measured on a four-point Likert scale ranging from 1(strongly disagree) to 4(strongly agree). The total scores range from 10 to 40 with higher scores indicating better self-esteem.	T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in depressive symptoms	The Patient Health Questionnaire (PHQ-9) is used as the measure of depression. This questionnaire consists of 9 items scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total scores can range from 0 to 27, with higher scores indication more severe depressive symptoms	T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in Anxiety symptoms	The Generalized Anxiety Disorder scale (GAD-7) is used to measure symptoms of generalized anxiety. The questionnaire consists of 7 items measured on a four-point Likert ranging from 0 (not at all) to 3 (nearly every day). The total scores range from 0 to 21 with higher scores indicating more severe GAD symptoms	T0 (Baseline) to T1 (Post-test: 4-weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio demographic characteristics of participants	age gender ethnicity student status study level relationship status whether the student is currently undergoing any treatment (pharmacotherapy/psychotherapy/both/none)	T0 (Baseline)
Satisfaction with individual modules	After completing each module, the participants respond to the question "how useful was this module" on a scale of 1 - 100, with higher scores indicating better satisfaction with the module.	Module 1, Module 2, Module 3, Module 4
Satisfaction with badges	Satisfaction with the badges is measured after completing EsteemUp-G. Participants respond to 3 statements measured on a five-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). These statements are: "The badges were a good addition to the program", "I enjoyed collecting the badges", and "the badges increased my motivation to keep working on the program". The total satisfaction score ranges from 0 to 12, with higher scores indicating greater satisfaction with the badges.	T1 (Post-test: 4-weeks)

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Collaborators: Leiden University; University of Amsterdam; Maastricht University; Utrecht University; Erasmus University Rotterdam; InHolland University of Applied Sciences
• Investigators: Study Director: Pim Cuijpers, dr. Prof, VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VCWE-2022-135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No