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

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare with automated motivational messaging
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression, Anxiety focused on measuring mHealth, Engagement, Depression, Anxiety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80
  • Patient Health Questionnaire-9 (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
  • Access to Internet and a valid email address
  • 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).

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IntelliCare with automated motivational messaging

Arm Description

Digital mental health intervention with micro-randomized automated motivational messaging delivery

Outcomes

Primary Outcome Measures

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 3 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 Outcome Measures

Message likability ratings
Mean Likert-scale rating of how much participants liked each message as rated within 3 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.
Engagement
Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery.

Full Information

First Posted
April 29, 2022
Last Updated
May 15, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05360901
Brief Title
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I
Official Title
A Pilot Study Aimed at Developing Automated Motivational Messaging for Patient Engagement With Digital Mental Health Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
mHealth, Engagement, Depression, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, micro-randomized pilot trial design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IntelliCare with automated motivational messaging
Arm Type
Other
Arm Description
Digital mental health intervention with micro-randomized automated motivational messaging delivery
Intervention Type
Behavioral
Intervention Name(s)
IntelliCare with automated motivational messaging
Intervention Description
Digital mental health intervention with automated motivational messaging
Primary Outcome Measure Information:
Title
Message motivation ratings
Description
Mean Likert-scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 3 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.
Time Frame
3 hours from message delivery
Secondary Outcome Measure Information:
Title
Message likability ratings
Description
Mean Likert-scale rating of how much participants liked each message as rated within 3 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.
Time Frame
3 hours from message delivery
Title
Engagement
Description
Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery.
Time Frame
3 hours from message delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 Patient Health Questionnaire-9 (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 Access to Internet and a valid email address 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Lipschitz, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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