Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II
Purpose
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.
Conditions
- Depression
- Anxiety Disorders
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Intervention Model Description
- 2x2 factorial trial with micro-randomization in automated motivational messaging arms
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IntelliCare with Automated Motivational Messaging and Coach Support |
IntelliCare Plus mobile application intervention with two engagement strategies, automated motivational messaging and coach support. |
|
|
Experimental IntelliCare with Automated Motivational Messaging |
IntelliCare Plus mobile application intervention with one engagement strategy, automated motivational messaging. |
|
|
Experimental IntelliCare with Coach Support |
IntelliCare Plus mobile application intervention with one engagement strategy, coach support. |
|
|
Active Comparator IntelliCare Alone |
IntelliCare Plus mobile application intervention with no additional engagement strategy applied. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.
