Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults

Depression Clinical Trial

— ADAPT  

Official title:

Antidepressant Medication Adherence in Adults With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441399
• Other study ID #: 1P50MH113840-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 26, 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Financial incentives
Providing money for taking antidepressant medication

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antidepressant adherence	The number of antidepressant daily doses taken during the initial six weeks of treatment	Daily for first 6 weeks of study
Secondary	Antidepressant adherence post-intervention	The number of antidepressant daily doses taken between 6 and 12 weeks	Daily between 6 and 12 weeks
Secondary	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).	At baseline, 6 week follow-up, and 12 week follow-up