NCT06423417

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

June 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

May 8, 2024

Last Update Submit

June 17, 2025

Conditions

Internet-based InterventionWaiting List Control GroupDepressionAnxietyStressQuality of LifeMental WellbeingResilience

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Resilience (BRS)

    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)

    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)

    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)

    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)

    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)

  • +1 more secondary outcomes

Other Outcomes (4)

  • Depression and anxiety (PHQ-4) after each module.

    After each module (approximately once per week)

  • Client satisfaction (CSQ-8)

    4 weeks post-baseline active group and 4 weeks post-T2 wait list group.

  • E-coach evaluation (WAI-I)

    4 weeks post-baseline active group and 4 weeks post-T2 wait list group.

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: LifeHack

Control group

NO INTERVENTION

Participants in the waiting list control condition will start with the programme 4 weeks after randomization.

Interventions

LifeHackBEHAVIORAL

See arm description

LifeHack

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU Amsterdam

Amsterdam, Netherlands

RECRUITING

Leiden University

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Sanne van Luenen, PhD

    Leiden University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne van Luenen, PhD

CONTACT

0031-715277957s.van.luenen@fsw.leidenuniv.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor in the Clinical Psychology unit at the Institute of Psychology

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 21, 2024

Study Start

November 1, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

June 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)