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

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ClinicalTrials.gov Identifier: NCT03441399
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
University of Pennsylvania

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
Depression Other: Financial incentives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2018
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Antidepressant adherence post-intervention [ Time Frame: Daily between 6 and 12 weeks ]
    The number of antidepressant daily doses taken between 6 and 12 weeks

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441399


Locations
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United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Columbia University
Investigators
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Principal Investigator: Steven Marcus, PhD University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03441399    
Other Study ID Numbers: 1P50MH113840-01 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Medication Adherence
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms