Depression, Anxiety
Conditions
Keywords
mHealth, Engagement, Depression, Anxiety
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.
Interventions
BEHAVIORALIntelliCare with automated motivational messaging
Digital mental health intervention with automated motivational messaging
Sponsors
National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single group, micro-randomized pilot trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Message Motivation Ratings | 24 hours from message delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Message Likability Ratings | 24 hours from message delivery | 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. |
| Engagement | 3 hours from message delivery | Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | IntelliCare With Automated Motivational Messaging |
|---|---|
| Age, Continuous | 38.17 years STANDARD_DEVIATION 14.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Generalized Anxiety Disorder-7 (GAD-7) | 13.33 units on a scale STANDARD_DEVIATION 3.6 |
| Patient Health Questionnaire-8 (PHQ-8) | 11.08 units on a scale STANDARD_DEVIATION 5.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 24 hours from message delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare With Automated Motivational Messaging | Message Motivation Ratings | 6.33 units on a scale | Standard Deviation 2.02 |
Secondary
Engagement
Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery.
Time frame: 3 hours from message delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare With Automated Motivational Messaging | Engagement | 23.84 percent of messages resulting in app use | Standard Deviation 21.51 |
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.
Time frame: 24 hours from message delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare With Automated Motivational Messaging | Message Likability Ratings | 6.35 units on a scale | Standard Deviation 1.95 |