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

June 5, 2024 updated by: Jessica M. Lipschitz, Ph.D., Brigham and Women's Hospital

A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions

This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. Participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated Coach Support protocol (CS), a newly-developed automated motivational messaging protocol (AMM), both or neither. To further understand how messages in the AMM arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. Micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are AMMs a cue to action) and the relationship between message impact and context (e.g., day in study). Measured outcome data will include level of engagement (operationalized as minutes of intervention use) and weekly self-reports of clinical outcomes.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mass General Brigham primary care patient
  • Age 18-75
  • Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)
  • Owns a smartphone capable of running the study applications
  • Fluent in English.

Exclusion Criteria:

  • Diagnosis of bipolar I or bipolar II disorder per patient report or the patient's medical record
  • Diagnosis of any psychotic disorder per patient report or the patient's medical record
  • Current substance use disorder per patient report or the patient's medical record
  • Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IntelliCare with Automated Motivational Messaging and Coach Support
IntelliCare Plus mobile application intervention with two engagement strategies, automated motivational messaging and coach support.
Behavioral: IntelliCare Plus
Mobile-app-based digital mental health intervention for individuals struggling with depression and/or anxiety. The app reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
Experimental: IntelliCare with Automated Motivational Messaging
IntelliCare Plus mobile application intervention with one engagement strategy, automated motivational messaging.
Behavioral: IntelliCare Plus
Mobile-app-based digital mental health intervention for individuals struggling with depression and/or anxiety. The app reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
Experimental: IntelliCare with Coach Support
IntelliCare Plus mobile application intervention with one engagement strategy, coach support.
Behavioral: IntelliCare Plus
Mobile-app-based digital mental health intervention for individuals struggling with depression and/or anxiety. The app reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
Active Comparator: IntelliCare Alone
IntelliCare Plus mobile application intervention with no additional engagement strategy applied.
Behavioral: IntelliCare Plus
Mobile-app-based digital mental health intervention for individuals struggling with depression and/or anxiety. The app reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes of Intervention Use - Distal (Long-Term)
Time Frame: 8-week intervention period
Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Intervention engagement will be operationalized as minutes of active use over the intervention period.
8-week intervention period
Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)
Time Frame: For 3 hours after each decision point, over the 8-week intervention period
Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Proximal Intervention engagement will be operationalized as whether or not the intervention was used within 3 hours of a decision point (i.e., the point at which participants in the automated motivational messaging arms were randomized to receive or not receive an automated motivational message). This outcome only applies to participants randomized to receive automated motivational messaging.
For 3 hours after each decision point, over the 8-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)
Time Frame: 8-week intervention period
The PHQ-8 is a self-report measure of severity of depressive symptoms. It will be used to determine the impact of the intervention on symptoms of depression.
8-week intervention period
Change in Generalized Anxiety Disorder-7 (GAD-7) Self-Report Scale Score - Distal (Long-Term)
Time Frame: 8-week intervention period
The GAD-7 is a self-report measure of severity of anxiety symptoms. It will be used to determine the impact of the intervention on symptoms of anxiety.
8-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jessica M Lipschitz, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

July 20, 2025

Study Completion (Estimated)

July 20, 2025

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001673
  • K23MH120324 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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