- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423417
RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.
LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sanne van Luenen, PhD
- Phone Number: 0031-715277957
- Email: s.van.luenen@fsw.leidenuniv.nl
Study Locations
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-
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Amsterdam, Netherlands
- Recruiting
- VU Amsterdam
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Contact:
- Sanne van Luenen
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Leiden, Netherlands
- Recruiting
- Leiden University
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Contact:
- Sanne van Luenen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LifeHack
LifeHack is a guided (weekly feedback by a coach is provided) e-heath self-help application, which is based on cognitive behavioral techniques. The goal of LifeHack is to improve mental wellbeing. The guided internet-based self-help programme LifeHack was developed based on existing literature and adapted in collaboration with university students. The programme comprises twelve modules that are delivered via computer, laptop, tablet, or mobile phone. The modules take approximately 30 minutes on 4 themes (mood management, productivity, self-worth and relationships). Guidance: E-coaches will be trained clinical psychology master students. E-coaches will provide asynchronous written personalized feedback to each participant through the program platform within 48 hours (counting workdays only) after session completion. The aim of the written feedback is to increase motivation and adherence of the participants. |
See arm description
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No Intervention: Control group
Participants in the waiting list control condition will start with the programme 4 weeks after randomization.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental wellbeing (MHC-SF)
Time Frame: 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)
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Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011).
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience (BRS)
Time Frame: 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)
|
Brief Resilience Scale (Smith et al., 2008).
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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)
|
Depressive symptoms (PHQ-9)
Time Frame: 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)
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Patient Health Questionnaire - 9, PHQ-9 (Kroenke et al., 2001).
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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)
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Stress related symptoms (PSS-10)
Time Frame: 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)
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Perceived Stress Scale-10, PSS-10 (Cohen, 1988).
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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)
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Symptoms of anxiety (GAD-7)
Time Frame: 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)
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Generalized Anxiety Disorder-7 scale, GAD-7 (Spitzer et al., 2006).
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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)
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Quality of life (MHQoL)
Time Frame: 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)
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Mental Health Quality of Life questionnaire, MHQoL (Krugten et al., 2022).
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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)
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Demographics
Time Frame: T0 (baseline)
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E.g. gender, age, nationality
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T0 (baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression and anxiety (PHQ-4) after each module.
Time Frame: After each module (approximately once per week)
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Patient Health Questionnaire - 4 (Kroenke et al., 2009).
After each module, the PHQ-4 will be assessed in both groups.
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After each module (approximately once per week)
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Client satisfaction (CSQ-8)
Time Frame: 4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
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The Client Satisfaction Questionnaire, CSQ-8 (Larsen et al., 1979)
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4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
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E-coach evaluation (WAI-I)
Time Frame: 4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
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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)
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4 weeks post-baseline active group and 4 weeks post-T2 wait list group.
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Adherence (Log info)
Time Frame: 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)
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Adherence will be measured by the total number of completed sessions, time spent on the platform, and the number of logins.
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanne van Luenen, PhD, Leiden University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-10-30-S.vanLuenen-V1-506
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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