Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496646
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Antidepressant Adherence for Depressed Adults in Primary Care
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Testing Tailored Text Reminders and Financial Incentives to Enhance Antidepressant Adherence for Depressed Adults in Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial study is to compare different adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications We will examine whether personalized daily text messages with and without financial incentives improves anti-depressant adherence and depression symptoms as compared to treatment as usual no messages or incentives for taking medications
We will measure adherence with a wireless pill bottle and by assessment of electronic health prescription records Participants in the study will be asked to complete assessments of depression symptoms via telephone at 6 and 12 weeks
We will measure adherence with a wireless pill bottle and by assessment of electronic health prescription records Participants in the study will be asked to complete assessments of depression symptoms via telephone at 6 and 12 weeks
Detailed Description:
The proposed study examines use of modest financial incentives in conjunction with tailored text message reminders to determine the most effective and cost-effective support for establishing consistent antidepressant medication taking routines to improve clinical outcomes of adult primary care patients with depression We will conduct a 3-arm randomized controlled trial RCT to compare with usual care the short-term and extended effectiveness of two adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications We will examine whether personalized daily text messages with and without financial incentives improves antidepressant adherence and depression symptoms Adherence will be measured with a wireless pill bottle at 6 and 12 weeks Depression symptoms will be collected via telephone by a trained assessor at 6 and 12 weeks Our Specific Aims are to
i Determine the relative effectiveness of 1 12 weeks of personalized daily text reminders without financial incentives reminders alone 2 12 weeks of the text reminders paired with 6 weeks of financial incentives reminders and incentives compared with 3 usual care and with each other non-inferiority The primary outcome will be symptom response on the PHQ-9 depression rating scale at 12 weeks
ii Explore the effectiveness of each study intervention arm compared to usual care and to each other on antidepressant adherence at 6 and 12 weeks
iii Use qualitative inquiry of antidepressant adherent and non-adherent study patients to explore opportunities to maximize the effectiveness of the financial incentives and reminders to increase antidepressant medication adherence
Widespread problems with antidepressant adherence especially during the early stage of treatment undermine the primary care treatment of depression This study will test whether personalized daily text messages grounded in behavioral economics principles alone or combined with financial incentives based on contingency management principles improves depression outcomes
i Determine the relative effectiveness of 1 12 weeks of personalized daily text reminders without financial incentives reminders alone 2 12 weeks of the text reminders paired with 6 weeks of financial incentives reminders and incentives compared with 3 usual care and with each other non-inferiority The primary outcome will be symptom response on the PHQ-9 depression rating scale at 12 weeks
ii Explore the effectiveness of each study intervention arm compared to usual care and to each other on antidepressant adherence at 6 and 12 weeks
iii Use qualitative inquiry of antidepressant adherent and non-adherent study patients to explore opportunities to maximize the effectiveness of the financial incentives and reminders to increase antidepressant medication adherence
Widespread problems with antidepressant adherence especially during the early stage of treatment undermine the primary care treatment of depression This study will test whether personalized daily text messages grounded in behavioral economics principles alone or combined with financial incentives based on contingency management principles improves depression outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None