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

NCT05300906 | Completed

• 1 other identifier: Personalization Trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-being

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Adherence

  after 3 weeks

• Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.

  after 1 day

• Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.

  after 7 days

• Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.

  after 3 weeks

• Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.

  baseline, 8 weeks

Study Arms (2)

Personalized

EXPERIMENTAL

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

non-personalized

ACTIVE COMPARATOR

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

Interventions

personalized 2-week mobile wellbeing intervention BEHAVIORAL

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.

Personalized

non-personalized 2-week mobile wellbeing intervention BEHAVIORAL

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.

non-personalized

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Twente: lead

Study Sites (1)

University of Twente

Enschede, Netherlands

Location

Study Officials

• Saskia M Kelders, PhD

  University of Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 29, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

NL (1)