Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II (jq830)
August 31, 2026 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
Completed
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 time to disengagement and minutes of use) and weekly self-reports of clinical outcomes.
Study Type
Interventional
Enrollment (Actual)
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 Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115-5804
- Jessica Morrow Lipschitz
-
-
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+
- 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: SilverCloud with Automated Motivational Messaging and Coach Support
SilverCloud intervention with two engagement strategies, automated motivational messaging and coach support.
|
Digital mental health intervention for individuals struggling with depression and/or anxiety.
The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
|
|
Experimental: SilverCloud with Automated Motivational Messaging
Silvercloud intervention with one engagement strategy, automated motivational messaging.
|
Digital mental health intervention for individuals struggling with depression and/or anxiety.
The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
|
|
Experimental: SilverCloud with Coach Support
SilverCloud intervention with one engagement strategy, coach support.
|
Digital mental health intervention for individuals struggling with depression and/or anxiety.
The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
|
|
Active Comparator: SilverCloud Alone
SilverCloud intervention with no additional engagement strategy applied.
|
Digital mental health intervention for individuals struggling with depression and/or anxiety.
The intervention 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 |
|---|---|---|
|
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
|
|
Time to disengagement
Time Frame: 8-week intervention period
|
disengagement from the digital mental health intervention is defined as the first week of <1 minute of use after which there are no subsequent weeks with at least 1 minute of use
|
8-week intervention period
|
Secondary 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
June 25, 2025
Study Completion (Actual)
June 25, 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)
September 2, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
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.