Self EsteemNCT05582954
The Caring Universities Project: EsteemUp RCT
A study testing EsteemUp and EsteemUp-G in people with Self Esteem, run by VU University of Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Esteem
- What is being tested?
- EsteemUp and EsteemUp-G
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Nov 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None. All interested students are eligible to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Esteem
- Being tested
- EsteemUp, EsteemUp-G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsteemUpBehavioural
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-GBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| EsteemUp | Experimental | Participants assigned to this arm will receive a 4 week-guided e-health application - EsteemUp - to improve their self-esteem Receives: Behavioral: EsteemUp |
| EsteemUp -G | Active comparator | This group will receive the same intervention (EsteemUp) with the addition of gamification elements. Receives: Behavioral: EsteemUp; Behavioral: EsteemUp-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: T1 (post test: 4-weeks)
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: T0 (Baseline) to T1 (Post-test: 4-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start3 Nov 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam, University of Amsterdam, Leiden University, Maastricht University, Utrecht University, InHolland University of Applied Sciences
- Responsible party
- Principal investigator, Arpana Amarnath, VU University of Amsterdam
- Investigators
- Pim Cuijpers, dr. Prof, Study director, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582954
- Sponsor's protocol ID
- VCWE-2022-135
- Status last verified
- Nov 2022
- First submitted
- 10 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Guided E-health Programme (EsteemUp), With and Without Gamification Elements, to Increase Self-esteem in University Students.
- ClinicalTrials.gov ID
- NCT05582954
- Acronym / sponsor ID
- VCWE-2022-135
- Conditions
- Self Esteem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam, University of Amsterdam, Leiden University, Maastricht University, Utrecht University, InHolland University of Applied Sciences
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| EsteemUp | Experimental | Behavioral: EsteemUpParticipants assigned to this arm will receive a 4 week-guided e-health application - EsteemUp - to improve their self-esteem |
| EsteemUp -G | Active comparator | Behavioral: EsteemUp, Behavioral: EsteemUp-GThis group will receive the same intervention (EsteemUp) with the addition of gamification elements. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None. All interested students are eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsteemUpEsteemUp 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. | Behavioural | EsteemUp, EsteemUp -G |
| EsteemUp-GThe 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 | Behavioural | EsteemUp -G |
Primary outcome
Satisfaction with the intervention
Time frame: T1 (post test: 4-weeks)
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.
Treatment Adherence
Time frame: T1 (post test: 4-weeks)
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.
Satisfaction with E-coach
Time frame: T1 (post test: 4-weeks)
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
3 secondary outcomes
Change in self-esteem
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in depressive symptoms
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in Anxiety symptoms
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pim Cuijpers, dr. Prof study director
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsteemUp and EsteemUp-G in people with Self Esteem, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the intervention (time frame: T1 (post test: 4-weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.