Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults

NCT ID: NCT03441399

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-09-26

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Financial incentives

Intervention Type OTHER

Providing money for taking antidepressant medication

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.

Group Type EXPERIMENTAL

Financial incentives

Intervention Type OTHER

Providing money for taking antidepressant medication

Control

Participants in this condition will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Financial incentives

Providing money for taking antidepressant medication

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Marcus, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32965464 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30747719 (View on PubMed)

Other Identifiers

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1P50MH113840-01

Identifier Type: NIH

Identifier Source: org_study_id

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