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

NCT05360901 | Completed Results

• 2 other identifiers: 2020P000444K23MH120324
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Keywords

mHealth; Engagement; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Message Likability Ratings

  24 hours from message delivery

• Engagement

  3 hours from message delivery

Study Arms (1)

IntelliCare with automated motivational messaging

OTHER

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

Behavioral: IntelliCare with automated motivational messaging

Interventions

IntelliCare with automated motivational messaging BEHAVIORAL

Digital mental health intervention with automated motivational messaging

IntelliCare with automated motivational messaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Jessica M. Lipschitz
• Organization: Brigham and Women's Hospital

jlipschitz@bwh.harvard.edu

617-732-6548

Study Officials

• Jessica M Lipschitz, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, BWH Digital Behavioral Health & Informatics Research Program

Model Details: Single group, micro-randomized pilot trial design

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: July 6, 2022
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)