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CompletedNCT03441399ADAPTUpdated Oct 15, 2019

Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults

An interventional study of Financial incentives in Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Depression

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Keywords

  • Medication Adherence
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Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Prescribed antidepressant
  • Plan to take antidepressant as prescribed
  • Working cell phone that allows texting
  • Score on PHQ-9 ≥ 10

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    Control

    Participants in this condition will receive usual care.

Interventions

  • OtherFinancial incentives

    Providing money for taking antidepressant medication

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What researchers measure

Primary outcomes

  1. Antidepressant adherence

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

    Time frame: Daily for first 6 weeks of study

Secondary outcomes

  1. Antidepressant adherence post-intervention

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

    Time frame: Daily between 6 and 12 weeks

  2. 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).

    Time frame: At baseline, 6 week follow-up, and 12 week follow-up

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Study locations

1 site
  • University of Pennsylvania Health System
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • 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. PubMed 32965464 ↗
  • 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. PubMed 30747719 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03441399
Lead sponsor
University of Pennsylvania
Collaborators
Columbia University
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Mar 1, 2018
Primary completion
Sep 26, 2019
Completion
Sep 26, 2019
Last update
Oct 15, 2019

Study contacts

Steven Marcus, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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