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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555875
• Other study ID #: 2022P001673
• Secondary ID: K23MH120324
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: Brigham and Women's Hospital
• Contact: Jessica M Lipschitz, PhD
• Phone: 6177326548
• Email: jlipschitz[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Jessica Morrow Lipschitz	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of Intervention Use - Distal (Long-Term)	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.	8-week intervention period
Primary	Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)	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.	For 3 hours after each decision point, over the 8-week intervention period
Secondary	Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)	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.	8-week intervention period
Secondary	Change in Generalized Anxiety Disorder-7 (GAD-7) Self-Report Scale Score - Distal (Long-Term)	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.	8-week intervention period