Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I

Study Overview
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Brief Summary
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This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.

Detailed Description
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This is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. Participants will download a digital mental health intervention (IntelliCare) to use for three weeks. During this three-week period, participants will receive automated motivational messages on a randomized schedule. That is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). On days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. At the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development. The primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. We will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the three hours following message delivery.

Official Title
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A Pilot Study Aimed at Developing Automated Motivational Messaging for Patient Engagement With Digital Mental Health Interventions

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: IntelliCare with automated motivational messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Patient Health Questionnaire-8 (PHQ-9) score≥10 and/or Generalized Anxiety Disorder-7 (GAD-7) Score≥8 indicating clinically significant depression or anxiety respectively Owns a smartphone Fluent in English Individual has a Mass General Brigham primary care provider Exclusion Criteria: Diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or medical record. Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, micro-randomized pilot trial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IntelliCare with automated motivational messaging<br>Digital mental health intervention with micro-randomized automated motivational messaging delivery | Behavioral: IntelliCare with automated motivational messaging<br>* Digital mental health intervention with automated motivational messaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Message Motivation Ratings | Mean Likert scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 24 hours of message delivery. The Likert scale will range from 1 (not at all motivating) to 10 (very motivating) with a score of 5 being neutral. | 24 hours from message delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement | Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery. | 3 hours from message delivery | 
| Message Likability Ratings | Mean Likert scale rating of how much participants liked each message as rated within 24 hours of message delivery. The Likert scale will range from 1 (hated the message) to 10 (loved the message) with a score of 5 being neutral. | 24 hours from message delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Engagement, Depression, Anxiety