Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05300906
Enrollment
200
Registered
2022-03-29
Start date
2022-04-01
Completion date
2023-02-01
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-being

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.

Interventions

BEHAVIORALpersonalized 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.

BEHAVIORALnon-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.

Sponsors

University of Twente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Participants will not be informed about their randomized condition (personalized or non-personalized), but it is likely that they will infer it from the intervention that they receive.

Intervention model description

participants are randomized to either the personalized or the non-personalized intervention.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.baseline, 3 weeksWellbeing 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 weeksDepressive 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 weeksDepressive 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

MeasureTime frameDescription
Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks.baseline, 8 weeksDepressive 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.
Adherenceafter 3 weeksNumber of modules completed
Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks.baseline, 8 weeksDepressive 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 1 dayEngagement 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.
Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.baseline, 8 weeksWellbeing 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026