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

NCT ID: NCT05300906

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-02-01

Brief Summary

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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

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Conditions

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Well-being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Personalized

Participants in the personalized arm will receive the optimal combination of content, feedback and design, based on their baseline engagement scores.

Group Type EXPERIMENTAL

personalized 2-week mobile wellbeing intervention

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

non-personalized 2-week mobile wellbeing intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Twente

OTHER

Sponsor Role lead

Responsible Party

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Saskia Kelders

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saskia M Kelders, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Twente

Locations

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University of Twente

Enschede, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Personalization Trial

Identifier Type: -

Identifier Source: org_study_id

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