Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults (ADAPT)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial incentives
Sponsored by

About this trial
This is an interventional health services research trial for Depression focused on measuring Medication Adherence
Eligibility Criteria
Inclusion Criteria:
- Prescribed antidepressant
- Plan to take antidepressant as prescribed
- Working cell phone that allows texting
- Score on PHQ-9 ≥ 10
Exclusion Criteria:
- No antidepressant use in last 90 days
- Never been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder
- Not currently pregnant or breastfeeding
- No other serious medical condition
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Escalating Incentives
De-escalating Incentives
Control
Arm Description
Participants assigned to the escalating financial incentives will receive an increasing financial incentive for taking their antidepressant medication for the initial 6 weeks of treatment.
Participants assigned to the de-escalating financial incentives will receive a decreasing financial incentive for taking their antidepressant medication for the initial 6 weeks of treatment.
Participants in this condition will receive usual care.
Outcomes
Primary Outcome Measures
Antidepressant adherence
The number of antidepressant daily doses taken during the initial six weeks of treatment
Secondary Outcome Measures
Antidepressant adherence post-intervention
The number of antidepressant daily doses taken between 6 and 12 weeks
Depression symptoms
Severity of depressive symptoms as assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 measures depressive symptoms, with scores ranging from 0-27 (higher scores meaning more depressive symptoms).
Full Information
NCT ID
NCT03441399
First Posted
February 15, 2018
Last Updated
October 14, 2019
Sponsor
University of Pennsylvania
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03441399
Brief Title
Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults
Acronym
ADAPT
Official Title
Antidepressant Medication Adherence in Adults With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
September 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will test using financial incentives by leveraging decision-making biases to improve adherence to antidepressants among adults newly prescribed antidepressants. This study will compare the effects of usual care, increasing financial incentives, and decreasing financial incentives on daily antidepressant medication adherence and depression symptom control of non-elderly adults with Major Depressive Disorder.
Detailed Description
A three arm randomized controlled trial will compare interventions to promote antidepressant adherence. One hundred twenty adults with major depressive disorder (MDD) who are initiating antidepressant treatment will be randomized in equal proportion to 1) usual care, 2) usual care and an escalating daily financial incentive for 6 weeks, or 3) usual care and a de-escalating financial incentive for daily antidepressant adherence for 6 weeks. Study patients will participate in three assessments over a 12 week period as well as passive monitoring of antidepressant daily adherence through a wireless electronic pill bottle over the same 12 week period. The primary outcome will be the number of antidepressant daily doses taken during the initial six weeks of treatment. The secondary outcome will be daily adherence during the next six weeks following the discontinuation of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Medication Adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escalating Incentives
Arm Type
Experimental
Arm Description
Participants assigned to the escalating financial incentives will receive an increasing financial incentive for taking their antidepressant medication for the initial 6 weeks of treatment.
Arm Title
De-escalating Incentives
Arm Type
Experimental
Arm Description
Participants assigned to the de-escalating financial incentives will receive a decreasing financial incentive for taking their antidepressant medication for the initial 6 weeks of treatment.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this condition will receive usual care.
Intervention Type
Other
Intervention Name(s)
Financial incentives
Intervention Description
Providing money for taking antidepressant medication
Primary Outcome Measure Information:
Title
Antidepressant adherence
Description
The number of antidepressant daily doses taken during the initial six weeks of treatment
Time Frame
Daily for first 6 weeks of study
Secondary Outcome Measure Information:
Title
Antidepressant adherence post-intervention
Description
The number of antidepressant daily doses taken between 6 and 12 weeks
Time Frame
Daily between 6 and 12 weeks
Title
Depression symptoms
Description
Severity of depressive symptoms as assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 measures depressive symptoms, with scores ranging from 0-27 (higher scores meaning more depressive symptoms).
Time Frame
At baseline, 6 week follow-up, and 12 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prescribed antidepressant
Plan to take antidepressant as prescribed
Working cell phone that allows texting
Score on PHQ-9 ≥ 10
Exclusion Criteria:
No antidepressant use in last 90 days
Never been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder
Not currently pregnant or breastfeeding
No other serious medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Marcus, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32965464
Citation
Marcus SC, Reilly ME, Zentgraf K, Volpp KG, Olfson M. Effect of Escalating and Deescalating Financial Incentives vs Usual Care to Improve Antidepressant Adherence: A Pilot Randomized Clinical Trial. JAMA Psychiatry. 2021 Feb 1;78(2):222-224. doi: 10.1001/jamapsychiatry.2020.3000.
Results Reference
derived
PubMed Identifier
30747719
Citation
Beidas RS, Volpp KG, Buttenheim AN, Marcus SC, Olfson M, Pellecchia M, Stewart RE, Williams NJ, Becker-Haimes EM, Candon M, Cidav Z, Fishman J, Lieberman A, Zentgraf K, Mandell D. Transforming Mental Health Delivery Through Behavioral Economics and Implementation Science: Protocol for Three Exploratory Projects. JMIR Res Protoc. 2019 Feb 12;8(2):e12121. doi: 10.2196/12121.
Results Reference
derived
Learn more about this trial
Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults
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