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RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.

ConditionsInternet-based Intervention Waiting List Control Group Depression Anxiety Stress Quality of Life Mental Wellbeing Resilience

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16-99

SponsorUniversiteit Leiden

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

LifeHack
Behavioral
See arm description

Treatment groups

217 Participants

are divided into 2 treatment groups

Group A: LifeHackExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mental wellbeing (MHC-SF)

Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011).

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)

Secondary outcomes

1

Resilience (BRS)

Brief Resilience Scale (Smith et al., 2008).

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)

2

Depressive symptoms (PHQ-9)

Patient Health Questionnaire - 9, PHQ-9 (Kroenke et al., 2001).

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)

3

Stress related symptoms (PSS-10)

Perceived Stress Scale-10, PSS-10 (Cohen, 1988).

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)

4

Symptoms of anxiety (GAD-7)

Generalized Anxiety Disorder-7 scale, GAD-7 (Spitzer et al., 2006).

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)

Other outcomes

1

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

Patient Health Questionnaire - 4 (Kroenke et al., 2009). After each module, the PHQ-4 will be assessed in both groups.

Time frame

After each module (approximately once per week)

2

Client satisfaction (CSQ-8)

The Client Satisfaction Questionnaire, CSQ-8 (Larsen et al., 1979)

Time frame

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

3

E-coach evaluation (WAI-I)

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)

Time frame

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

4

Adherence (Log info)

Adherence will be measured by the total number of completed sessions, time spent on the platform, and the number of logins.

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)

Sponsors and contacts

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Universiteit Leiden

Lead sponsor

Maastricht University

Collaborator

VU University of Amsterdam

Collaborator

Utrecht University

Collaborator

University of Amsterdam

Collaborator

Rotterdam University of Applied Sciences

Collaborator

Erasmus University Rotterdam

Collaborator

Avans University of applied sciences

Collaborator

InHolland University of Applied Sciences

Collaborator

Source ClinicalTrials.gov