The Effectiveness of Engagement-based Personalization of a Digital Mental Health Intervention

Study Overview
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Brief Summary
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This study will investigate the effectiveness of an engagement-based personalized 2-week mobile wellbeing intervention, vs the effectiveness of a non-personalized 2-week mobile wellbeing intervention.

Official Title
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The Effectiveness of Engagement-based Personalization of a Two-week Digital Mental Health Intervention Targeting Wellbeing: a Randomized Controlled Trial

Conditions
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Well-being

Intervention / Treatment
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* Behavioral: personalized 2-week mobile wellbeing intervention
* Behavioral: non-personalized 2-week mobile wellbeing intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least mild depressive or anxiety complaints; >4 Generalized Anxiety Disorder 7-item scale OR Patient Health Questionnaire 9-item scale access to smartphone with internet adequate English literacy Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants are randomized to either the personalized or the non-personalized intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized<br>Participants in the personalized arm will receive the optimal combination of content, feedback and design, based on their baseline engagement scores. | Behavioral: personalized 2-week mobile wellbeing intervention<br>* For the study, 27 versions of a 2-week mobile wellbeing intervention are created. These versions vary on content (Cognitive Behavioral Therapy, meaning, positive psychology), feedback (text, text with avatar, pre-recorded video) and design (non-gamified, competitively gamified, storyline gamified). At baseline, participants preview all variations and indicate their expected engagement. Participants in the personalized condition will receive the optimal combination of content, feedback and design, based on their baseline engagement scores. Each version of the intervention consists of a module per day. Each module contains psychoeducation and exercises based on content of the version. Moreover, each module contains pre-specified general feedback and supportive messages.<br>|
| Active Comparator: non-personalized<br>Participants in the non-personalized arm will receive a randomly selected version of the 27 possible interventions, regardless of their baseline engagement scores. | Behavioral: non-personalized 2-week mobile wellbeing intervention<br>* For the study, 27 versions of a 2-week mobile wellbeing intervention are created. These versions vary on content (Cognitive Behavioral Therapy, meaning, positive psychology), feedback (text, text with avatar, pre-recorded video) and design (non-gamified, competitively gamified, storyline gamified). At baseline, participants preview all variations and indicate their expected engagement. Participants in the non-personalized condition will receive a random version of the intervention. Each version of the intervention consists of a module per day. Each module contains psychoeducation and exercises based on content of the version. Moreover, each module contains pre-specified general feedback and supportive messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks. | Wellbeing will be measured in an online survey, using the Mental Health Continuum Short Form. This validated scale consists of 14 items. The scale's total scores range from 14 to 84, with higher scores indicating higher wellbeing and thus better outcomes. | baseline, 3 weeks | 
| Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 3 weeks. | Depressive symptoms will be measured in an online survey, using the Patient Health Questionnaire-9. This validated scale consists of 9 items. The scale's total scores range from 0 to 27, with higher scores indicating higher depressive symptoms and thus worse outcomes. | baseline, 3 weeks | 
| Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 3 weeks. | Depressive symptoms will be measured in an online survey, using the Generalized Anxiety Disorder 7-item scale. This validated scale consists of 6 items. The scale's total scores range from 0 to 21, with higher scores indicating higher anxiety symptoms and thus worse outcomes. | baseline, 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks. | Depressive symptoms will be measured in an online survey, using the Patient Health Questionnaire-9. This validated scale consists of 9 items. The scale's total scores range from 0 to 27, with higher scores indicating higher depressive symptoms and thus worse outcomes. | baseline, 8 weeks | 
| Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks. | Depressive symptoms will be measured in an online survey, using the Generalized Anxiety Disorder 7-item scale. This validated scale consists of 6 items. The scale's total scores range from 0 to 21, with higher scores indicating higher anxiety symptoms and thus worse outcomes. | baseline, 8 weeks | 
| Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks. | Wellbeing will be measured in an online survey, using the Mental Health Continuum Short Form. This validated scale consists of 14 items. The scale's total scores range from 14 to 84, with higher scores indicating higher wellbeing and thus better outcomes. | baseline, 8 weeks | 
| Adherence | Number of modules completed | after 3 weeks | 
| Engagement, measured with the TWente Engagement with Ehealth Technologies Scale. | Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes. | after 1 day | 
| Engagement, measured with the TWente Engagement with Ehealth Technologies Scale. | Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes. | after 7 days | 
| Engagement, measured with the TWente Engagement with Ehealth Technologies Scale. | Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes. | after 3 weeks |