Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423417
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-08
Brief Title:
RCT the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students
Sponsor:
Universiteit Leiden
Organization:
Universiteit Leiden
Study Overview
Official Title:
LifeHack RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None