Clinical trial NCT05596396: The Caring Universities Project: LifeHack
Official title: Feasibility and Acceptability of a Guided E-health Program (LifeHack), With and Without a Fixed Structure, to Improve Well-being in University Students.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Well-being
Keywords: well-being
positive mental health
guided
e-health
university students
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Erasmus University Rotterdam
name: University of Amsterdam
name: Leiden University
name: Maastricht University
name: Utrecht University
name: InHolland University of Applied Sciences
First posted: 2022-10-27
Enrollment: 356
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 positive mental health and well-being (LifeHack) will be compared to an unstructured version of the same intervention (LifeHack-C)
Primary purpose: TREATMENT

Brief summary: Within the Caring Universities project (study protocol VCWE- 2021-175 accepted by the VCWE), the investigators have developed a guided e-health programme (LifeHack) designed to improve positive mental health in university students. With the current study, the investigators aim to examine the feasibility and acceptability of LifeHack - with and without a fixed structure - to improve students' positive mental health and well-being.

The secondary goals are to gain insight into pre-test to post-test differences regarding general well-being, 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 a fixed structure (LifeHack) or a flexible structure (LifeHack-C).

LifeHack was developed based on existing literature and adapted in collaboration with university students to meet the specific needs of the university students. LifeHack is based on cognitive-behavioural therapy (CBT). It consists of fourteen modules, of which six are principal (compulsory) modules. These include one introductory module, four main modules covering the themes of mood, studies, social life and self-esteem, and one closing module. In addition, there are two optional modules per theme, totalling to eight optional modules.

Every module consists of evidence-based information, exercises, and homework assignments that are delivered via computer, laptop, tablet, or mobile phone. The content is delivered in text format with pictures and infographics. The intervention is available in both English and Dutch.

Participants assigned to LifeHack will follow a fixed structure where the themes are delivered in a predefined order, and the contents get unlocked sequentially. Participants assigned to LifeHack-C will receive the same intervention, but they can choose what theme they would like to start with, when to work on it and how many modules they wish to complete.

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 well-being, 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 LifeHack free of charge, which will likely improve their general well-being. They will not receive any additional incentives for participation.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction with the intervention
timeFrame: T1 (post test: 4-weeks)
measure: Treatment Adherence
timeFrame: T1 (post test: 4-weeks)
measure: Satisfaction with E-coach
timeFrame: T1 (post test: 4-weeks)
measure: Usability
timeFrame: T1 (post test: 4-weeks)
Secondary outcomes:
measure: Change in positive mental health and well-being
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
measure: Change in depressive symptoms
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
measure: Change in Anxiety symptoms
timeFrame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Other outcomes:
measure: Socio demographic characteristics of participants
timeFrame: T0 (Baseline)
measure: Satisfaction with individual modules
timeFrame: After completing each module, through Week 1, Week 2, Week 3, Week 4
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Pim Cuijpers, dr. Prof
role: STUDY_DIRECTOR
References: