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Trial Outcomes & Findings for Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I (NCT NCT05360901)

NCT ID: NCT05360901

Last Updated: 2023-12-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

24 hours from message delivery

Results posted on

2023-12-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IntelliCare With Automated Motivational Messaging
n=12 Participants
Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging
Age, Continuous
38.17 years
STANDARD_DEVIATION 14.35 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Generalized Anxiety Disorder-7 (GAD-7)
13.33 units on a scale
STANDARD_DEVIATION 3.60 • n=5 Participants
Patient Health Questionnaire-8 (PHQ-8)
11.08 units on a scale
STANDARD_DEVIATION 5.98 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
IntelliCare With Automated Motivational Messaging
n=12 Participants
Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging
Message Motivation Ratings
6.33 units on a scale
Standard Deviation 2.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
IntelliCare With Automated Motivational Messaging
n=12 Participants
Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging
Message Likability Ratings
6.35 units on a scale
Standard Deviation 1.95

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
IntelliCare With Automated Motivational Messaging
n=12 Participants
Digital mental health intervention with micro-randomized automated motivational messaging delivery IntelliCare with automated motivational messaging: Digital mental health intervention with automated motivational messaging
Engagement
23.84 percent of messages resulting in app use
Standard Deviation 21.51

Adverse Events

IntelliCare With Automated Motivational Messaging

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica M. Lipschitz

Brigham and Women's Hospital

Phone: 617-732-6548

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place