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Clinical Trials/NCT05360901
NCT05360901
Completed
N/A

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

Brigham and Women's Hospital1 site in 1 country12 target enrollmentJuly 6, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression, Anxiety
Sponsor
Brigham and Women's Hospital
Enrollment
12
Locations
1
Primary Endpoint
Message Motivation Ratings
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 6, 2022
End Date
October 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica M. Lipschitz, Ph.D.

Associate Director, BWH Digital Behavioral Health & Informatics Research Program

Brigham and Women's Hospital

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Message Motivation Ratings

Time Frame: 24 hours from message delivery

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.

Secondary Outcomes

  • Message Likability Ratings(24 hours from message delivery)
  • Engagement(3 hours from message delivery)

Study Sites (1)

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