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

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.

Study Overview

• Status: Completed
• Conditions: Well-being
• Intervention / Treatment: Behavioral: personalized 2-week mobile wellbeing intervention; Behavioral: non-personalized 2-week mobile wellbeing intervention

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands
    • University of Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized; 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; 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.
Active Comparator: non-personalized; 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; 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.

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: University of Twente
• Investigators: Principal Investigator: Saskia M Kelders, PhD, University of Twente

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Personalization Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan is to share anonymized data from the study in a open science database. Specifics are not yet established.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No