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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03441399
Collaborator
Columbia University (Other)
120
1
3
18.9
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Financial incentives
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Antidepressant Medication Adherence in Adults With Depression
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Sep 26, 2019
Actual Study Completion Date :
Sep 26, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Antidepressant adherence [Daily for first 6 weeks of study]

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

Secondary Outcome Measures

  1. Antidepressant adherence post-intervention [Daily between 6 and 12 weeks]

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

  2. Depression symptoms [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 64 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Columbia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03441399
Other Study ID Numbers:
  • 1P50MH113840-01
First Posted:
Feb 22, 2018
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2019