Clinical trial NCT05360901: Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I
Official title: A Pilot Study Aimed at Developing Automated Motivational Messaging for Patient Engagement With Digital Mental Health Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: mHealth
Engagement
Depression
Anxiety
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-05-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, micro-randomized pilot trial design
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Message Motivation Ratings
timeFrame: 24 hours from message delivery
Secondary outcomes:
measure: Message Likability Ratings
timeFrame: 24 hours from message delivery
measure: Engagement
timeFrame: 3 hours from message delivery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jessica M Lipschitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: