NCT03441399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

February 15, 2018

Last Update Submit

October 14, 2019

Conditions

Depression

Keywords

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Antidepressant adherence

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

    Daily for first 6 weeks of study

Secondary Outcomes (2)

  • Antidepressant adherence post-intervention

    Daily between 6 and 12 weeks

  • Depression symptoms

    At baseline, 6 week follow-up, and 12 week follow-up

Study Arms (3)

Escalating Incentives

EXPERIMENTAL

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

De-escalating Incentives

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in this condition will receive usual care.

Interventions

Financial incentivesOTHER

Providing money for taking antidepressant medication

De-escalating IncentivesEscalating Incentives

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 32965464DERIVED

  • 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.

    PMID: 30747719DERIVED

MeSH Terms

Conditions

DepressionMedication Adherence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Steven Marcus, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

March 1, 2018

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)