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

NCT ID: NCT05360901

Last Updated: 2023-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2022-10-17

Brief Summary

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This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.

Detailed Description

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This is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. Participants will download a digital mental health intervention (IntelliCare) to use for three weeks. During this three-week period, participants will receive automated motivational messages on a randomized schedule. That is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). On days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. At the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development.

The primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. We will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the three hours following message delivery.

Conditions

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Depression, Anxiety

Keywords

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mHealth Engagement Depression Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group, micro-randomized pilot trial design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IntelliCare with automated motivational messaging

Digital mental health intervention with micro-randomized automated motivational messaging delivery

Group Type OTHER

IntelliCare with automated motivational messaging

Intervention Type BEHAVIORAL

Digital mental health intervention with automated motivational messaging

Interventions

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IntelliCare with automated motivational messaging

Digital mental health intervention with automated motivational messaging

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* Patient Health Questionnaire-8 (PHQ-9) score≥10 and/or Generalized Anxiety Disorder-7 (GAD-7) Score≥8 indicating clinically significant depression or anxiety respectively
* Owns a smartphone
* Fluent in English
* Individual has a Mass General Brigham primary care provider

Exclusion Criteria

* Diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or 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

80 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.

Associate Director, BWH Digital Behavioral Health & Informatics Research Program

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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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23MH120324

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P000444

Identifier Type: -

Identifier Source: org_study_id