The Caring Universities Project: EsteemUp RCT

Self Esteem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05582954
• Other study ID #: VCWE-2022-135
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2022
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 356
• Est. completion date: November 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self Esteem

Intervention

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.
• 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

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Amsterdam	Amsterdam

Sponsors (7)

Lead Sponsor	Collaborator
VU University of Amsterdam	Erasmus University Rotterdam, InHolland University of Applied Sciences, Leiden University, Maastricht University, University of Amsterdam, Utrecht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)