Clinical trial NCT03441399: Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults
Official title: Antidepressant Medication Adherence in Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Medication Adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2018-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Antidepressant adherence
timeFrame: Daily for first 6 weeks of study
Secondary outcomes:
measure: Antidepressant adherence post-intervention
timeFrame: Daily between 6 and 12 weeks
measure: Depression symptoms
timeFrame: At baseline, 6 week follow-up, and 12 week follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Steven Marcus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.