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

Not Applicable

Completed

• Conditions: Well-being
• Interventions: Behavioral: personalized 2-week mobile wellbeing intervention; Behavioral: non-personalized 2-week mobile wellbeing intervention

• Registration Number: NCT05300906
• Lead Sponsor: University of Twente

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-29
• Study Start: 2022-04-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized	personalized 2-week mobile wellbeing intervention	Participants in the personalized arm will receive the optimal combination of content, feedback and design, based on their baseline engagement scores.
non-personalized	non-personalized 2-week mobile wellbeing intervention	Participants in the non-personalized arm will receive a randomly selected version of the 27 possible interventions, regardless of their baseline engagement scores.

Primary Outcome Measures

Name	Time	Method
Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.	baseline, 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.
Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 3 weeks.	baseline, 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.
Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 3 weeks.	baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Adherence	after 3 weeks	Number of modules completed
Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.	baseline, 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.
Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks.	baseline, 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.
Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks.	baseline, 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.
Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.	after 3 weeks	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.

Trial Locations

Locations (1)

University of Twente; 🇳🇱 Enschede, Netherlands