Anxiety Clinical Trial
Official title:
Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | May 5, 2024 |
Est. primary completion date | May 5, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 32 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus University Rotterdam | Rotterdam | South Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus University Rotterdam |
Netherlands,
Laure T, Engels RCME, Remmerswaal D, Spruijt-Metz D, Konigorski S, Boffo M. Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in stress symptoms | 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. | At baseline and days 21, 56, and 84. | |
Primary | Changes in ER skills | 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. | At baseline, and days 56 and 84. | |
Secondary | Changes in depressive symptoms | Depressive symptoms are measured with the Patient Health Questionnaire (PHQ-9). Participants are asked to indicate how often they have been bothered by a certain symptom over the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). PHQ-9 scores range from 0-27. Higher scores indicate higher levels of depressive symptoms. | At baseline and day 84 | |
Secondary | Changes in anxiety symptoms | Anxiety symptoms are measured with the Generalized Anxiety Disorder (GAD-7) questionnaire. Participants are asked to indicate how often they have been bothered by a certain symptom over the last two weeks on a scale from 0 (not at all) to 3 (nearly every day). The scores on GAD-7 range between 0-21, with higher scores indicating higher levels of anxiety. | At baseline and day 84 | |
Secondary | Changes in resilience levels | Resilience levels are evaluated with the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Items are scored on a scale ranging from 0 (not true at all) to 4 (true nearly all the time). Total scores range between 0 and 40 with higher scores indicating greater resilience. | At baseline and day 84 | |
Secondary | Objective engagement patterns | Objective engagement patterns include exercise completion and non-completion (i.e., exercise started but not finished) rates, average time spent on each exercise, engagement in self-assessment module (i.e., number of questionnaires and Ecological Momentary Assessments completed), the number of objects collected in the "virtual room", the number of times the app was accessed. Log data is used to evaluate objective engagement patterns. | Day 1 - 84 | |
Secondary | Subjective engagement: Exercise likeability and helpfulness | Exercise likeability and helpfulness is evaluated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much) every time a participant completes an exercise.
How much did you like the exercise? How helpful did you find the exercise? |
Day 1-84 | |
Secondary | Subjective engagement: Likeability and helpfulness of Self-assessment component | The likeability and helpfulness of the Self-assessment module (MapMyself) is evaluated on a scale from 1 (not at all) to 5 (very much)
How much did you like the self-assessment (MapMyself) feature in the app? How helpful did you find the self-assessment (MapMyself) feature in the app? |
Day 56 | |
Secondary | Subjective engagement: Likeabilty of Virtual Collectibles Room | The likeability of the Virtual Collectibles Room component is assessed on a scale ranging from 1 (not at all) to 5 (very much)
- How much do you like collecting objects in the ROOM app? |
Day 56 | |
Secondary | Subjective engagement: Usefulness and perceived effectiveness of recommendation system | Participants are asked to evaluate the recommendation system by rating the following two questions on a scale from 1 (not at all) to 5 (very much)
How useful do you find the in-app recommendations of the exercises? How well do the in-app recommendations of exercises align with your self-reported moods? |
Day 56 | |
Secondary | Subjective engagement: User experience with the app | User experiences are evaluated with a User Experience Questionnaire (UEQ) measuring the Attractiveness, Perspicuity, Efficiency, Dependability, and Novelty of the app. The questionnaire includes 26 items measured on a semantic differential (e.g., attractive - unattractive). The items are scored from -3 (the most negative answer) to +3 (the most positive answer), with 0 representing a neutral answer. | Day 56 | |
Secondary | Engagement with the exercises outside of the app: In app counter | The mobile intervention includes a feature (i.e., an exercise counter) where users can log in the number of times they completed an exercise outside of the app.
This counter is used to evaluate the number of exercises performed independently from the app. |
Day 1-84 | |
Secondary | Engagement with ER techniques outside of the app | Participants are asked to evaluate how often they applied ER techniques (e.g., self-compassion, breathing pattern, savouring, being mindful, reframing unhelpful thoughts) in their daily life over the past month on a scale from 0 (not at all) - 4 (daily).
- Over the past month, how frequently have you spontaneously used any of the techniques you've learned in ROOM app either to manage your emotions during challenging times or to improve your overall mood? |
Day 21, 56, 84 | |
Secondary | Likability and helpfulness of transfer strategies offered in the app | For evaluation of the learning transfer features in the app, participant will be asked to rate the following questions on a scale from (0 - Not at all; 100 - Very much or So far I haven't used this feature).
How much do you like action planning with 'when-then' statements? How helpful do you find the action planning with 'when-then' statements? How much do you like to use stickers to create cues to practice the techniques? How helpful do you find stickers to create cues to practice the techniques? How much do you like the 'practice semi-guided' feature of the app? How helpful do you find the 'practice semi-guided' feature of the app? |
Day 56 |
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