Clinical trial NCT05555875: Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II
Official title: A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety Disorders
Keywords: Mobile app
Engagement
Depression
Anxiety
Micro-randomized trial
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-09-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial trial with micro-randomization in automated motivational messaging arms
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Minutes of Intervention Use - Distal (Long-Term)
timeFrame: 8-week intervention period
measure: Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)
timeFrame: For 3 hours after each decision point, over the 8-week intervention period
Secondary outcomes:
measure: Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)
timeFrame: 8-week intervention period
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Self-Report Scale Score - Distal (Long-Term)
timeFrame: 8-week intervention period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jessica Morrow Lipschitz
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jessica M Lipschitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: