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The Caring Universities Project: EsteemUp RCT

V

VU University of Amsterdam

Status

Invitation-only

Conditions

Self Esteem

Treatments

Behavioral: EsteemUp
Behavioral: EsteemUp-G

Study type

Interventional

Funder types

Other

Identifiers

NCT05582954
VCWE-2022-135

Details and patient eligibility

About

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.

Full 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.

Enrollment

356 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

356 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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