Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Changes in stress symptoms
研究概览
简要总结
This study is a two-armed randomized controlled trial (RCT) aimed at evaluating the effectiveness and adoption of a transdiagnostic mobile app intervention that focuses is on enhancing adaptive emotional regulation (ER) skills among university students.
详细描述
Globally, an estimated 30% of university students struggle with mental health issues, primarily anxiety, depression, and substance abuse. Recent trends have highlighted the potential of online interventions for accessible, low-threshold support in preventing these issues among this demographic.
At Erasmus University Rotterdam (EUR), a transdiagnostic mobile app is being developed as part of a student wellbeing program. This app provides a range of tools aimed at improving mental health by teaching students adaptive emotional regulation strategies. It incorporates exercises from various therapeutic modalities, addressing factors like negative thoughts, rumination, and prolonged negative emotions. Delivered through a smartphone, the app includes 24 therapeutic exercises focusing on techniques such as enhancing positive emotions, mindfulness, cognitive defusion, cognitive restructuring, relaxation, breathing, and self-compassion.
The present study is a 12-week two-armed RCT study with outcomes assessed at the baseline, and three follow-ups at weeks 3, 8, and 12. It compares a group of distressed students with access to the mobile app intervention against a waitlist control group.
The main goal of the study is to assess the impact of the intervention on stress symptoms and emotional regulation skills. The secondary outcomes of the study, include an evaluation of the intervention's impact on depression, anxiety symptoms, and students' resilience levels. Lastly, the study examines the app's uptake, including engagement patterns and user experiences, and evaluates the real-life application of the skills learned through the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The investigator conducting the analyses will be blinded to group assignments, remaining unaware of which data corresponds to the control group and which to the intervention group.
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate and provide informed consent
- •Access to smartphone and internet
- •Feels comfortable with English language for verbal and written communication and interaction with the app
- •Scores <13 on the Perceived Stress Scale (PSS-10)
排除标准
- •Scores >20 on the Patient Health Questionnaire (PHQ-9)
- •Having a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
- •Undergoing psychopharmacological treatment or treatment with experimental drugs
研究组 & 干预措施
Access to the intervention
Participants assigned to the intervention group will have full access to the mobile app intervention, namely ROOM app, for the whole duration of the 12-week trial.
As part of the app's onboarding process, participants will receive tips on optimal app usage and can decide to take part in a 21-day challenge where they are encouraged to assess their emotional states on a daily basis and complete one exercise per day. During the onboarding process, participants are encouraged to explore different emotional regulation exercises offered in the app and to save the ones they find most beneficial in their "virtual Room", curating a personalized well-being toolkit. While daily notifications prompt regular app engagement, no additional efforts are made to further promote its use.
干预措施: Mobile Transdiagnostic Emotion Regulation Intervention (Behavioral)
Waitlist control condition
Participants allocated to the control group will be put on a waitlist and granted access to the mobile intervention after the trial concludes. They will then receive the same intervention with the identical onboarding process as the intervention group.
结局指标
主要结局
Changes in stress symptoms
时间窗: At baseline and days 21, 56, and 84.
Perceived Stress Scale (PSS-10) is used to evaluate participants' stress levels. Participants are asked to specify how often they felt or thought a certain way over the last month on a scale from 0 \[never\] to 5 \[very often\]. The score ranges from 0 - 40, with higher scores indicating higher levels of perceived stress symptoms.
Changes in ER skills
时间窗: At baseline, and days 56 and 84.
The Emotion Regulation Skills Questionnaire (ERSQ) will be used to assess emotion regulation skills. This instrument includes seven distinct emotion regulation skills: awareness, sensation, clarity, understanding, acceptance, tolerance, compassionate self-support, confrontation readiness, and modification of negative emotions. It consists of 27 items, each scored on a scale ranging from 0 (not at all) to 4 (almost always). Higher scores on both the ERSQ subscales and the aggregate ERSQ score are indicative of higher emotion regulation skills.
次要结局
- Subjective engagement: Likeability and helpfulness of Self-assessment component(Day 56)
- Subjective engagement: Likeabilty of Virtual Collectibles Room(Day 56)
- Engagement with ER techniques outside of the app(Day 21, 56, 84)
- Likability and helpfulness of transfer strategies offered in the app(Day 56)
- Changes in depressive symptoms(At baseline and day 84)
- Subjective engagement: User experience with the app(Day 56)
- Objective engagement patterns(Day 1 - 84)
- Subjective engagement: Exercise likeability and helpfulness(Day 1-84)
- Subjective engagement: Usefulness and perceived effectiveness of recommendation system(Day 56)
- Engagement with the exercises outside of the app: In app counter(Day 1-84)
- Changes in anxiety symptoms(At baseline and day 84)
- Changes in resilience levels(At baseline and day 84)
研究者
Marilisa Boffo
Assistant professor of Clinical Psychology and eHealth
Erasmus University Rotterdam