The Caring Universities Project: LifeHack

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.

Study Overview

• Status: Recruiting
• Conditions: Well-being
• Intervention / Treatment: Behavioral: LifeHack; Behavioral: LifeHack-C

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 Type: Interventional
• Enrollment (Anticipated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sascha Y Struijs, PhD; Phone Number: +316 48 20 62 23; Email: s.y.struijs@vu.nl
• Study Contact Backup: Name: Sevin Ozmen, MSc; Email: s.ozmen@vu.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1181 HV
    • Recruiting
    • Vrije Universiteit Amsterdam
    • Contact: Sascha Y Struijs
    • Contact: Sevin Ozmen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None. All interested students are eligible to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LifeHack; Participants assigned to this arm will receive a 6-week guided e-health intervention to increase positive mental health and well-being.	Behavioral: LifeHack; 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.
Active Comparator: LifeHack-C; Participants assigned to this arm will receive the same intervention, delivered over 2 to 6 weeks.	Behavioral: LifeHack-C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	T1 (post test: 4-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	T0 (Baseline) to T1 (Post-test: 4-weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio demographic characteristics of participants	age, gender, ethnicity, student status, study level, relationship status, whether the student is currently undergoing any treatment (pharmacotherapy/psychotherapy/both/none)	T0 (Baseline)
Satisfaction with individual modules	After completing each module, the participants respond to the question "how useful was this module" on a scale of 1 - 100, with higher scores indicating better satisfaction with the module.	After completing each module, through Week 1, Week 2, Week 3, Week 4

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Collaborators: Leiden University; University of Amsterdam; Maastricht University; Utrecht University; Erasmus University Rotterdam; InHolland University of Applied Sciences
• Investigators: Study Director: Pim Cuijpers, dr. Prof, VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: well-being; university students; e-health; guided; positive mental health
• Other Study ID Numbers: VCWE-2021-175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No