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

Well-being Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300906
• Other study ID #: Personalization Trial
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: University of Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Well-being

Intervention

Behavioral:
• personalized 2-week mobile wellbeing intervention
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.
• non-personalized 2-week mobile wellbeing intervention
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.

Locations

Country	Name	City	State
Netherlands	University of Twente	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Adherence	Number of modules completed	after 3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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