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

NCT ID: NCT05555875

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-07-20

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial trial with micro-randomization in automated motivational messaging arms
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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IntelliCare with Automated Motivational Messaging and Coach Support

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

Group Type EXPERIMENTAL

IntelliCare Plus

Intervention Type 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 with Automated Motivational Messaging

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

Group Type EXPERIMENTAL

IntelliCare Plus

Intervention Type 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 with Coach Support

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

Group Type EXPERIMENTAL

IntelliCare Plus

Intervention Type 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 Plus mobile application intervention with no additional engagement strategy applied.

Group Type ACTIVE_COMPARATOR

IntelliCare Plus

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jessica M. Lipschitz, Ph.D.

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica M Lipschitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Jessica Morrow Lipschitz

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica M Lipschitz, PhD

Role: CONTACT

6177326548

Katherine E Burdick, PhD

Role: CONTACT

Facility Contacts

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Jessica M Lipschitz, PhD

Role: primary

617-732-6548

Katherine E Burdick, PhD

Role: backup

Other Identifiers

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K23MH120324

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P001673

Identifier Type: -

Identifier Source: org_study_id

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