RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.

Depression Clinical Trial

Official title:

LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423417
• Other study ID #: 2023-10-30-S.vanLuenen-V1-506
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Universiteit Leiden
• Contact: Sanne van Luenen, PhD
• Phone: 0031-715277957
• Email: s.van.luenen[@]fsw.leidenuniv.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychological issues are common among university students and affect mental wellbeing. The Caring Universities (CU) project, involving nine Dutch universities, aims to enhance students' mental health through an annual online questionnaire and a platform offering guided eHealth interventions. One intervention, LifeHack, utilizes cognitive behavioral therapy-based modules to improve mental wellbeing by enhancing resilience and life skills. The effects of LifeHack with pre-post measurements (total n = 216 at post-test) found found that LifeHack led to improvements in mental wellbeing, but dropout rates were influenced by lack of motivation and module relevance. A personalized version of LifeHack is being developed to address these issues and will be evaluated in an RCT to assess its effectiveness in improving mental wellbeing and related outcomes among university students.

Description:

Psychological problems are prevalent among university students and are associated with lower mental wellbeing and resilience. Universities provide an excellent environment for students to enhance mental wellbeing, resilience, and acquire life skills. Caring Universities (CU) is an internationally embedded consortium of nine Dutch universities aimed at improving students' mental wellbeing. The CU project consists of two components: 1) an annual online questionnaire assessing students' mental health; and 2) a platform offering free, guided eHealth interventions to enhance mental well-being. One of the interventions on the CU platform - called LifeHack - seeks to enhance mental wellbeing by increasing resilience, teaching life skills, and strengthening mental wellbeing. LifeHack is a guided eHealth intervention based on cognitive behavioural therapy, comprising 13 modules of approximately 30 minutes each focusing on four themes (mood management, productivity, self-worth, and relationships). We investigated the effects of LifeHack with pre-post measurements (total n = 216 at post-test) and found that after following LifeHack, mental wellbeing improved with small to moderate effect sizes. Additionally, students reported satisfaction with the programme and the eCoach. However, participants indicated lack of motivation and early symptom reduction as important reasons for drop-out. Furthermore, the diverse topics covered in LifeHack may not be relevant to all students, leading to more dropouts. Currently, there are two versions of LifeHack: one 'structured', where modules must be completed in order, and one 'free choice', where all modules are available from the start and none are mandatory. For the proposed study, the free choice version of LifeHack will be used and adapted in co-creation with students as follows: participants will be asked which topics they find most important and want to work on. Based on their answers, a personalized selection of modules will be presented, and students can choose which module to start with. Each module is standalone, allowing students to proceed to another module or stop after completing one or more. Each module has a clear structure, beginning with goal formulation and concluding with an action plan. The new adapted version of LifeHack will be personalized and tailored for each student, aiming to improve motivation and reduce dropout rates. With the current study, we aim to examine the effectiveness of the adapted version of LifeHack in an RCT to enhance mental wellbeing in university students. Secondary objectives include investigating differences between the intervention and control groups on students' self-report questionnaire resilience scores, depression scores, anxiety scores, stress-related scores, and mental health quality of life scores (pretest vs post-test). Additional outcomes include satisfaction with the programme and the eCoach, as well as adherence to the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 217
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

• Being fluent in Dutch and/or English
• Being enrolled as a student at one of the 9 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
• Score of 50 or lower on the MHC-SF. This is 1 SD above the mean baseline score of participants of LifeHack. This inclusion criterion ensures no students with optimal mental wellbeing are included because they will not be able to show any change.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Internet-based Intervention
• Mental Wellbeing
• Quality of Life
• Resilience
• Stress
• Waiting List Control Group

Intervention

Behavioral:
• LifeHack
See arm description

Locations

Country	Name	City	State
Netherlands	VU Amsterdam	Amsterdam
Netherlands	Leiden University	Leiden

Sponsors (9)

Lead Sponsor	Collaborator
Universiteit Leiden	Avans University of applied sciences, Erasmus University Rotterdam, InHolland University of Applied Sciences, Maastricht University, Rotterdam University of Applied Sciences, University of Amsterdam, Utrecht University, VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression and anxiety (PHQ-4) after each module.	Patient Health Questionnaire - 4 (Kroenke et al., 2009). After each module, the PHQ-4 will be assessed in both groups.	After each module (approximately once per week)
Other	Client satisfaction (CSQ-8)	The Client Satisfaction Questionnaire, CSQ-8 (Larsen et al., 1979)	4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
Other	E-coach evaluation (WAI-I)	We will also ask participants to evaluate the e-coach at the post-test. The questions about e-coach evaluation will be based on the Working Alliance Inventory for Guided Internet Interventions (WAI-I) (Gómez Penedo et al., 2020)	4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
Other	Adherence (Log info)	Adherence will be measured by the total number of completed sessions, time spent on the platform, and the number of logins.	T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Primary	Mental wellbeing (MHC-SF)	Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Resilience (BRS)	Brief Resilience Scale (Smith et al., 2008).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Depressive symptoms (PHQ-9)	Patient Health Questionnaire - 9, PHQ-9 (Kroenke et al., 2001).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Stress related symptoms (PSS-10)	Perceived Stress Scale-10, PSS-10 (Cohen, 1988).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Symptoms of anxiety (GAD-7)	Generalized Anxiety Disorder-7 scale, GAD-7 (Spitzer et al., 2006).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Quality of life (MHQoL)	Mental Health Quality of Life questionnaire, MHQoL (Krugten et al., 2022).	T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups)
Secondary	Demographics	E.g. gender, age, nationality	T0 (baseline)