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临床试验/NCT03441399
NCT03441399已完成不适用

Antidepressant Medication Adherence in Adults With Depression

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Antidepressant adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Financial incentives (Other)

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.

干预措施: Financial incentives (Other)

Control

No Intervention

Participants in this condition will receive usual care.

结局指标

主要结局

Antidepressant adherence

时间窗: Daily for first 6 weeks of study

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

次要结局

  • Depression symptoms(At baseline, 6 week follow-up, and 12 week follow-up)
  • Antidepressant adherence post-intervention(Daily between 6 and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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