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

Mass General Brigham

Status: Enrolling

Conditions: Depression; Anxiety Disorders

Treatments: Behavioral: IntelliCare Plus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05555875

2022P001673

K23MH120324 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

IntelliCare with Automated Motivational Messaging and Coach Support

Experimental group

Description:

IntelliCare Plus mobile application intervention with two engagement strategies, automated motivational messaging and coach support.

Treatment:

Behavioral: IntelliCare Plus

IntelliCare with Automated Motivational Messaging

Experimental group

Description:

IntelliCare Plus mobile application intervention with one engagement strategy, automated motivational messaging.

Treatment:

Behavioral: IntelliCare Plus

IntelliCare with Coach Support

Experimental group

Description:

IntelliCare Plus mobile application intervention with one engagement strategy, coach support.

Treatment:

Behavioral: IntelliCare Plus

IntelliCare Alone

Active Comparator group

Description:

IntelliCare Plus mobile application intervention with no additional engagement strategy applied.

Treatment:

Behavioral: IntelliCare Plus