The Caring Universities Project: LifeHack

NCT05596396 | Unknown

• 1 other identifier: VCWE-2021-175
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-being

Keywords

well-being; positive mental health; guided; e-health; university students

Outcome Measures

Primary Outcomes (4)

• 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)

• Treatment Adherence

  Adherence refers to the degree to which the user followed the program as it was designed. The present study measures adherence by dividing the number of modules completed by a participant at the time of post-test by the total number of modules in the programme and multiplying this by 100. The resulting percentage will indicate the completion rate.

  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

  T1 (post test: 4-weeks)

• Usability

  The System Usability Scale (SUS-10) is used to measure the usability of the intervention. It consists of 10 items on a five-point Likert scale with a total score ranging from 0 to 100, where a higher score indicates greater usability.

  T1 (post test: 4-weeks)

Secondary Outcomes (3)

• Change in positive mental health and well-being

  T0 (Baseline) to T1 (Post-test: 4-weeks)

• Change in depressive symptoms

  T0 (Baseline) to T1 (Post-test: 4-weeks)

• Change in Anxiety symptoms

  T0 (Baseline) to T1 (Post-test: 4-weeks)

Other Outcomes (2)

• Socio demographic characteristics of participants

  T0 (Baseline)

• Satisfaction with individual modules

  After completing each module, through Week 1, Week 2, Week 3, Week 4

Study Arms (2)

LifeHack

EXPERIMENTAL

Participants assigned to this arm will receive a 6-week guided e-health intervention to increase positive mental health and well-being.

Behavioral: LifeHack

LifeHack-C

ACTIVE COMPARATOR

Participants assigned to this arm will receive the same intervention, delivered over 2 to 6 weeks.

Behavioral: LifeHack-C

Interventions

LifeHack BEHAVIORAL

Participants assigned to LifeHack will follow a six week-guided online intervention with a fixed structure where the themes are delivered in a predefined order, and the contents get unlocked sequentially. The first mandatory module is the introduction module which also functions as a goal-setting module. Following this, students complete one mandatory module per week (and the optional modules if they choose to do so) delivered sequentially, starting with the theme of mood, studies, social life and finally, self-esteem. Students complete the themes one by one and the consecutive themes (and modules) are unlocked only after completing the main module of the assigned theme.

LifeHack

LifeHack-C BEHAVIORAL

Participants assigned to LifeHack-C will receive the same guided online 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. After completing the introduction module, the participants will be advised to complete two modules per week and at least four in total. Therefore, the program's duration will be approximately two and six weeks. However, participants can follow the program at their own pace.

LifeHack-C

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None. All interested students are eligible to participate.

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Erasmus University Rotterdam: collaborator
• University of Amsterdam: collaborator
• Leiden University: collaborator
• Maastricht University: collaborator
• Utrecht University: collaborator
• InHolland University of Applied Sciences: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, 1181 HV, Netherlands

RECRUITING

Study Officials

• Pim Cuijpers, dr. Prof

  VU University of Amsterdam

  STUDY DIRECTOR

Central Study Contacts

Sascha Y Struijs, PhD

CONTACT

+316 48 20 62 23; s.y.struijs@vu.nl

Sevin Ozmen, MSc

CONTACT

s.ozmen@vu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent researcher who is not involved in the study will generate the random sequence using a computer random sequence generator. Randomisation will take place at an individual level, stratified by gender and the university where students study. Participants will be randomised into two groups (LifeHack vs LifeHack-C) with an allocation ratio of 1:1. Block randomisation with randomly varied block sizes (6 to 12 allocations per block) will be conducted to prevent foreknowledge of intervention assignment. Allocation will be concealed from the study's researchers. It is not possible to mask personnel and participants to the treatment allocation because of the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: 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)

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 27, 2022
• Study Start: November 2, 2021
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

NL (1)