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.
Verified date | November 2022 |
Source | VU University of Amsterdam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Vrije Universiteit Amsterdam | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University of Amsterdam | Erasmus University Rotterdam, InHolland University of Applied Sciences, Leiden University, Maastricht University, University of Amsterdam, Utrecht University |
Netherlands,
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) |
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