Internet-based InterventionNCT06423417
RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.
A study testing LifeHack in people with Internet-based Intervention and Waiting List Control Group, run by Universiteit Leiden at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Internet-based Intervention, Waiting List Control Group, Depression
- What is being tested?
- LifeHack
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Nov 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
VU Amsterdam
Amsterdam
Sanne van Luenen
- Recruiting
Leiden University
Leiden
Sanne van Luenen
About this study
Official title: LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students.
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.
Read the 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.
- Conditions
- Internet-based Intervention, Waiting List Control Group, Depression, Anxiety, Stress, Quality of Life
- Being tested
- LifeHack
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeHackBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| LifeHack | Experimental | 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. Receives: Behavioral: LifeHack |
| Control group | No intervention | Participants in the waiting list control condition will start with the programme 4 weeks after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental wellbeing (MHC-SF)
Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011).
Measured: 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 outcomes (6)
Resilience (BRS)
Brief Resilience Scale (Smith et al., 2008).
Measured: 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)
Patient Health Questionnaire - 9, PHQ-9 (Kroenke et al., 2001).
Measured: 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)
Stress related symptoms (PSS-10)
Perceived Stress Scale-10, PSS-10 (Cohen, 1988).
Measured: 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)
Symptoms of anxiety (GAD-7)
Generalized Anxiety Disorder-7 scale, GAD-7 (Spitzer et al., 2006).
Measured: 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)
Quality of life (MHQoL)
Mental Health Quality of Life questionnaire, MHQoL (Krugten et al., 2022).
Measured: 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)
Demographics
E.g. gender, age, nationality
Measured: T0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Nov 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet-based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a two-arm randomized controlled superiority trial. This trial will be conducted in a university setting. A guided web-based resilience and mental wellbeing programme (LifeHack) will be compared to a waiting list condition. Participants in the waiting list condition will start with the programme 4 weeks after randomization.
- Masking
- None (open label)
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, VU University of Amsterdam, Utrecht University, University of Amsterdam, Rotterdam University of Applied Sciences, Erasmus University Rotterdam, Avans University of applied sciences, InHolland University of Applied Sciences
- Responsible party
- Principal investigator, Sanne van Luenen, Universiteit Leiden
- Investigators
- Sanne van Luenen, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423417
- Sponsor's protocol ID
- 2023-10-30-S.vanLuenen-V1-506
- Status last verified
- May 2025
- First submitted
- 8 May 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students.
- ClinicalTrials.gov ID
- NCT06423417
- Acronym / sponsor ID
- 2023-10-30-S.vanLuenen-V1-506
- Conditions
- Internet-based Intervention, Waiting List Control Group, Depression, Anxiety, Stress, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- Maastricht University, VU University of Amsterdam, Utrecht University, University of Amsterdam, Rotterdam University of Applied Sciences, Erasmus University Rotterdam, Avans University of applied sciences, InHolland University of Applied Sciences
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a two-arm randomized controlled superiority trial. This trial will be conducted in a university setting. A guided web-based resilience and mental wellbeing programme (LifeHack) will be compared to a waiting list condition. Participants in the waiting list condition will start with the programme 4 weeks after randomization.
| Arm | Type | Receives |
|---|---|---|
| LifeHack | Experimental | Behavioral: LifeHackLifeHack 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. |
| Control group | No intervention | –Participants in the waiting list control condition will start with the programme 4 weeks after randomization. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeHackSee arm description | Behavioural | LifeHack |
Primary outcome
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)
Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011).
6 secondary outcomes
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)
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)
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)
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)
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)
Demographics
Time frame: T0 (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanne van Luenen, PhD principal investigator
Leiden University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeHack in people with Internet-based Intervention and Waiting List Control Group, run by Universiteit Leiden at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanne van Luenen, PhD (0031-715277957, s.van.luenen@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.