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

Not Applicable

Recruiting

• Conditions: Anxiety Disorders; Depression
• Interventions: Behavioral: IntelliCare Plus

• Registration Number: NCT05555875
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2023-06-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-07-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IntelliCare with Coach Support	IntelliCare Plus	IntelliCare Plus mobile application intervention with one engagement strategy, coach support.
IntelliCare Alone	IntelliCare Plus	IntelliCare Plus mobile application intervention with no additional engagement strategy applied.
IntelliCare with Automated Motivational Messaging	IntelliCare Plus	IntelliCare Plus mobile application intervention with one engagement strategy, automated motivational messaging.
IntelliCare with Automated Motivational Messaging and Coach Support	IntelliCare Plus	IntelliCare Plus mobile application intervention with two engagement strategies, automated motivational messaging and coach support.

Primary Outcome Measures

Name	Time	Method
Minutes of Intervention Use - Distal (Long-Term)	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.
Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder-7 (GAD-7) Self-Report Scale Score - Distal (Long-Term)	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.
Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)	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.

Trial Locations

Locations (1)

Jessica Morrow Lipschitz; 🇺🇸 Boston, Massachusetts, United States