Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults (ADAPT)

October 14, 2019 updated by: University of Pennsylvania

Antidepressant Medication Adherence in Adults With Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
No Intervention: Control
Participants in this condition will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Daily for first 6 weeks of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antidepressant adherence post-intervention
Time Frame: Daily between 6 and 12 weeks
The number of antidepressant daily doses taken between 6 and 12 weeks
Daily 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).
At baseline, 6 week follow-up, and 12 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Columbia University

Investigators

  • Principal Investigator: Steven Marcus, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

September 26, 2019

Study Completion (Actual)

September 26, 2019

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1P50MH113840-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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