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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360901
• Other study ID #: 2020P000444
• Secondary ID: K23MH120324
• Status: Completed
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Behavioral:
• IntelliCare with automated motivational messaging
Digital mental health intervention with automated motivational messaging

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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