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

NCT05555875 | Recruiting

• 2 other identifiers: 2022P001673K23MH120324
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety Disorders

Keywords

Mobile app; Engagement; Depression; Anxiety; Micro-randomized trial

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)

  8-week intervention period

• Change in Generalized Anxiety Disorder-7 (GAD-7) Self-Report Scale Score - Distal (Long-Term)

  8-week intervention period

Study Arms (4)

IntelliCare with Automated Motivational Messaging and Coach Support

EXPERIMENTAL

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

Behavioral: IntelliCare Plus

IntelliCare with Automated Motivational Messaging

EXPERIMENTAL

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

Behavioral: IntelliCare Plus

IntelliCare with Coach Support

EXPERIMENTAL

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

Behavioral: IntelliCare Plus

IntelliCare Alone

ACTIVE COMPARATOR

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

Behavioral: IntelliCare Plus

Interventions

IntelliCare Plus BEHAVIORAL

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.

IntelliCare Alone; IntelliCare with Automated Motivational Messaging; IntelliCare with Automated Motivational Messaging and Coach Support; IntelliCare with Coach Support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Jessica Morrow Lipschitz

Boston, Massachusetts, 02115-5804, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jessica M Lipschitz, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M Lipschitz, PhD

CONTACT

6177326548; jlipschitz@bwh.harvard.edu

Katherine E Burdick, PhD

CONTACT

kburdick1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 2x2 factorial trial with micro-randomization in automated motivational messaging arms

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 27, 2022
• Study Start: June 7, 2023
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)