Feasibility and Acceptability of a Guided E-health Program (LifeHack), With and Without a Fixed Structure, to Improve Well-being in University Students.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 356
- 试验地点
- 2
- 主要终点
- Treatment Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
An independent researcher who is not involved in the study will generate the random sequence using a computer random sequence generator. Randomisation will take place at an individual level, stratified by gender and the university where students study. Participants will be randomised into two groups (LifeHack vs LifeHack-C) with an allocation ratio of 1:1. Block randomisation with randomly varied block sizes (6 to 12 allocations per block) will be conducted to prevent foreknowledge of intervention assignment. Allocation will be concealed from the study's researchers. It is not possible to mask personnel and participants to the treatment allocation because of the nature of the intervention
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •None. All interested students are eligible to participate.
结局指标
主要结局
Treatment Adherence
时间窗: 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 the intervention
时间窗: 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.
Usability
时间窗: 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.
Satisfaction with E-coach
时间窗: 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
次要结局
- Change in Anxiety symptoms(T0 (Baseline) to T1 (Post-test: 4-weeks))
- Change in positive mental health and well-being(T0 (Baseline) to T1 (Post-test: 4-weeks))
- Change in depressive symptoms(T0 (Baseline) to T1 (Post-test: 4-weeks))
研究者
Arpana Amarnath
Research Associate
VU University of Amsterdam