Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults

ID: NCT03441399
Status: Not yet recruiting
Phase: N/A
Start Date: February 01, 2018
First Submitted: February 15, 2018
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Columbia University
Location: N/A
Conditions: Depression
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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.
Condition or disease Intervention/treatment Phase

Depression

Other: Financial incentives
Other Names
N/A

Tracking Information

First Submitted DateFebruary 15, 2018
Last Update Posted DateFebruary 22, 2018
Anticipated Start DateFebruary 01, 2018
Anticipated Completion DateMay 01, 2020
Anticipated Primary Completion DateMay 01, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Antidepressant adherence [Time Frame: Daily for first 6 weeks of study]

    The number of antidepressant daily doses taken during the initial six weeks of treatment

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Antidepressant adherence post-intervention [Time Frame: Daily between 6 and 12 weeks]

    The number of antidepressant daily doses taken between 6 and 12 weeks

  • Depression symptoms [Time Frame: At baseline, 6 week follow-up, and 12 week follow-up]

    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).

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults
Official TitleAntidepressant Medication Adherence in Adults With Depression
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
120
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Health Services Research
Conditions
Depression
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Financial incentives

Providing money for taking antidepressant medication

Other Names
Study Groups/Cohorts
Escalating Incentives
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.

De-escalating Incentives
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.

Control
Participants in this condition will receive usual care.

Study Arms
Experimental De-escalating Incentives
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.
Other : Financial incentives
Providing money for taking antidepressant medication

Experimental Escalating Incentives
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.
Other : Financial incentives
Providing money for taking antidepressant medication

Arm Intervention/Treatment
Experimental De-escalating Incentives
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.
Other : Financial incentives
Experimental Escalating Incentives
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.
Other : Financial incentives

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment120
Completion DateMay 01, 2020
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
GenderAll
Age21 Years to 64 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03441399
Other Study ID Numbers
1P50MH113840-01
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Columbia University
Investigators
Principal Investigator
Steven Marcus, PhD
University of Pennsylvania