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DIAMANTE Adaptive for Depression (DIAMANTE Trial)
N/A
Waitlist Available
Led By Adrian Aguilera, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HbA1c (Hemoglobin A1c) > 7
PHQ-8 (Patient Health Questionnaire-8) > 5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
DIAMANTE Trial Summary
This trial is testing a smartphone intervention that sends adaptive messages to help manage diabetes. The messages are personalized based on daily patient data. The goal is to improve physical activity at 6-month follow-up.
Eligible Conditions
- Depression
- Physical Activity
- Diabetes
DIAMANTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDIAMANTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physical Activity
Secondary outcome measures
Hemoglobin A1c
Patient Health Questionnaire-8 (PHQ-8)
DIAMANTE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive MessagingExperimental Treatment1 Intervention
Patients in the adaptive messaging arm will receive the daily messages of the static arm, and additionally receive daily messages within different categories of feedback and motivational messages that are chosen using a reinforcement learning (RL) algorithm. Physical activity (step-count/day) will be actively monitored via the app on their smartphone.
Group II: Static MessagingActive Control1 Intervention
We will send patients a total of seven messages per week (one per day) at 10.00 am. For the physical health management messages we use messages from established topics in the Diabetes Prevention Program(23) content with the emphasis on physical activity and stress management. The final message, on the seventh day will ask patients to rate their mood on a scale from 1 to 9. Physical activity (step-count/day) will be passively monitored via the app on their smartphone.
Group III: Control ConditionActive Control1 Intervention
Control patients will only install the app on their phone and will not receive any feedback messages. They will receive one message a week, on a fixed day, asking them to assess their mood in the previous week on a scale of 1 to 9. The message will be sent daily at 10:00 am. Non-responders will receive reminders to submit their mood self-assessments in two hour intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DIAMANTE Adaptive
2020
N/A
~230
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,495 Previous Clinical Trials
11,932,943 Total Patients Enrolled
71 Trials studying Depression
28,602 Patients Enrolled for Depression
Agency for Healthcare Research and Quality (AHRQ)FED
398 Previous Clinical Trials
7,088,533 Total Patients Enrolled
17 Trials studying Depression
12,687 Patients Enrolled for Depression
University of California, BerkeleyOTHER
177 Previous Clinical Trials
720,698 Total Patients Enrolled
10 Trials studying Depression
7,064 Patients Enrolled for Depression
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