NCT05555875

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Depression
• Anxiety Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-07-20
• Completion: 2025-07-20
• First posted: 2022-09-27
• Last updated: 2024-06-06

Locations

1 site across 1 country: United States