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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH120324 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IntelliCare with automated motivational messaging | Other | Digital mental health intervention with micro-randomized automated motivational messaging delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliCare with automated motivational messaging | Behavioral | Digital mental health intervention with automated motivational messaging |
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| Measure | Description | Time Frame |
|---|---|---|
| Message Motivation Ratings | Mean Likert scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 24 hours of message delivery. The Likert scale will range from 1 (not at all motivating) to 10 (very motivating) with a score of 5 being neutral. | 24 hours from message delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Message Likability Ratings | Mean Likert scale rating of how much participants liked each message as rated within 24 hours of message delivery. The Likert scale will range from 1 (hated the message) to 10 (loved the message) with a score of 5 being neutral. | 24 hours from message delivery |
| Engagement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica M Lipschitz, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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Participants were recruited via Massachusetts General Brigham Listservs and patient registries between June 2022 and September 2022. The first participant was enrolled on July 6, 2022 and the last participant was enrolled on September 22, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | IntelliCare With Automated Motivational Messaging | Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IntelliCare With Automated Motivational Messaging | Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Message Motivation Ratings | Mean Likert scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 24 hours of message delivery. The Likert scale will range from 1 (not at all motivating) to 10 (very motivating) with a score of 5 being neutral. | Posted | Mean | Standard Deviation | units on a scale | 24 hours from message delivery |
|
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IntelliCare With Automated Motivational Messaging | Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica M. Lipschitz | Brigham and Women's Hospital | 617-732-6548 | jlipschitz@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2023 | Oct 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Oct 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Single group, micro-randomized pilot trial design
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Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery. |
| 3 hours from message delivery |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Generalized Anxiety Disorder-7 (GAD-7) | Generalized Anxiety Disorder-7 (GAD-7) is a self-report questionnaire used to screen for and measure the severity of anxiety disorders. Total scores range from 0-21, with higher scores indicating greater severity of anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-8 (PHQ-8) | Patient Health Questionnaire-8 (PHQ-8) is a self-report questionnaire used to screen for and measure the severity of depression. Total scores range from 0-24, with higher scores indicating greater severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Message Likability Ratings | Mean Likert scale rating of how much participants liked each message as rated within 24 hours of message delivery. The Likert scale will range from 1 (hated the message) to 10 (loved the message) with a score of 5 being neutral. | Posted | Mean | Standard Deviation | units on a scale | 24 hours from message delivery |
|
|
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| Secondary | Engagement | Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery. | Posted | Mean | Standard Deviation | percent of messages resulting in app use | 3 hours from message delivery |
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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