Well-beingNCT05596396
The Caring Universities Project: LifeHack
A study testing LifeHack and LifeHack-C in people with Well-being, run by VU University of Amsterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- LifeHack and LifeHack-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None. All interested students are eligible to participate.
Trial locations and contacts
1 site in 1 country.
Sevin Ozmen, MSc contact
Netherlands1 site, 1 recruiting
- Recruiting
Vrije Universiteit Amsterdam
Amsterdam, 1181 HV
Sascha Y Struijs
Sevin Ozmen
About this study
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.
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.
Read the 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.
- Conditions
- Well-being
- Being tested
- LifeHack, LifeHack-C
- Keywords
- well-being, positive mental health, guided, e-health, university students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeHackBehavioural
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-CBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LifeHack | Experimental | Participants assigned to this arm will receive a 6-week guided e-health intervention to increase positive mental health and well-being. Receives: Behavioral: LifeHack |
| LifeHack-C | Active comparator | Participants assigned to this arm will receive the same intervention, delivered over 2 to 6 weeks. Receives: Behavioral: LifeHack-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: T1 (post test: 4-weeks)
Secondary outcomes (3)
Change in positive mental health and well-being
The Mental Health Continuum - Short Form (MHC-SF) is used to measure positive mental health. It comprises of 14 items that represent various feelings of emotional, psychological and social well-being. These items are measured on a six point Likert scale ranging from 1 (never) to 6 (every day). The scores range from 14 to 84 with higher scores indication greater positive mental health and well-being.
Measured: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in depressive symptoms
The Patient Health Questionnaire (PHQ-9) is used as the measure of depression. This questionnaire consists of 9 items scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total scores can range from 0 to 27, with higher scores indication more severe depressive symptoms.
Measured: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in Anxiety symptoms
The Generalized Anxiety Disorder scale (GAD-7) is used to measure symptoms of generalized anxiety. The questionnaire consists of 7 items measured on a four-point Likert ranging from 0 (not at all) to 3 (nearly every day). The total scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.
Measured: T0 (Baseline) to T1 (Post-test: 4-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start2 Nov 2021
- Primary completionFeb 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam, University of Amsterdam, Leiden University, Maastricht University, Utrecht University, InHolland University of Applied Sciences
- Responsible party
- Principal investigator, Arpana Amarnath, VU University of Amsterdam
- Investigators
- Pim Cuijpers, dr. Prof, Study director, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596396
- Sponsor's protocol ID
- VCWE-2021-175
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05596396
- Acronym / sponsor ID
- VCWE-2021-175
- Conditions
- Well-being
- Keywords
- well-being, positive mental health, guided, e-health, university students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam, University of Amsterdam, Leiden University, Maastricht University, Utrecht University, InHolland University of Applied Sciences
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 27 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| LifeHack | Experimental | Behavioral: LifeHackParticipants assigned to this arm will receive a 6-week guided e-health intervention to increase positive mental health and well-being. |
| LifeHack-C | Active comparator | Behavioral: LifeHack-CParticipants assigned to this arm will receive the same intervention, delivered over 2 to 6 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None. All interested students are eligible to participate.
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 |
|---|---|---|
| LifeHackParticipants 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. | Behavioural | LifeHack |
| LifeHack-CParticipants 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. | Behavioural | LifeHack-C |
Primary outcome
Satisfaction with the intervention
Time frame: T1 (post test: 4-weeks)
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.
Treatment Adherence
Time frame: T1 (post test: 4-weeks)
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.
Satisfaction with E-coach
Time frame: T1 (post test: 4-weeks)
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
Usability
Time frame: T1 (post test: 4-weeks)
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.
3 secondary outcomes
Change in positive mental health and well-being
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in depressive symptoms
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Change in Anxiety symptoms
Time frame: T0 (Baseline) to T1 (Post-test: 4-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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. This study is not recruiting at the moment.
Sevin Ozmen, MSc contact
Pim Cuijpers, dr. Prof study director
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeHack and LifeHack-C in people with Well-being, run by VU University of Amsterdam at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha Y Struijs, PhD (+316 48 20 62 23, s.y.struijs@vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the intervention (time frame: T1 (post test: 4-weeks)). The study lists 4 primary outcomes in all. 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 27 Oct 2022.