Clinical trial NCT06496646: Antidepressant Adherence for Depressed Adults in Primary Care
Official title: Testing Tailored Text Reminders and Financial Incentives to Enhance Antidepressant Adherence for Depressed Adults in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Medication adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 525
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized controlled trial study is to compare different adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications. We will examine whether personalized daily text messages with and without financial incentives improves anti-depressant adherence and depression symptoms as compared to treatment as usual (no messages or incentives for taking medications).

We will measure adherence with a wireless pill bottle and by assessment of electronic health prescription records. Participants in the study will be asked to complete assessments of depression symptoms via telephone at 6 and 12 weeks.

Detailed description: The proposed study examines use of modest financial incentives in conjunction with tailored text message reminders to determine the most effective and cost-effective support for establishing consistent antidepressant medication taking routines to improve clinical outcomes of adult primary care patients with depression. We will conduct a 3-arm randomized controlled trial (RCT) to compare with usual care the short-term and extended effectiveness of two adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications. We will examine whether personalized daily text messages with and without financial incentives improves antidepressant adherence and depression symptoms. Adherence will be measured with a wireless pill bottle at 6 and 12 weeks. Depression symptoms will be collected via telephone by a trained assessor at 6 and 12 weeks. Our Specific Aims are to:

i. Determine the relative effectiveness of 1) 12 weeks of personalized daily text reminders without financial incentives (reminders alone), 2) 12 weeks of the text reminders paired with 6 weeks of financial incentives (reminders and incentives), compared with 3) usual care, and with each other (non-inferiority). The primary outcome will be symptom response on the PHQ-9 depression rating scale at 12 weeks.

ii. Explore the effectiveness of each study intervention arm compared to usual care and to each other on antidepressant adherence at 6 and 12 weeks.

iii. Use qualitative inquiry of antidepressant adherent and non-adherent study patients to explore opportunities to maximize the effectiveness of the financial incentives and reminders to increase antidepressant medication adherence.

Widespread problems with antidepressant adherence, especially during the early stage of treatment, undermine the primary care treatment of depression. This study will test whether personalized daily text messages grounded in behavioral economics principles alone or combined with financial incentives based on contingency management principles improves depression outcomes.

Eligibility criteria: Inclusion Criteria:

* Penn Medicine primary care outpatients
* Clinical diagnosis of major depressive disorder
* A score of 10 on the Patient Health Questionnaire 9 (PHQ-9)
* Age 21 to 64 years at the time of study entry
* Prescribed an antidepressant by their primary care clinician
* Express interest in taking antidepressant medication
* Own a cell phone
* Capable of using the electronic pill bottle

Exclusion Criteria:

* Treated with antidepressants in the past 90 days
* Pregnant or post-partum
* An active substance use disorder other than nicotine
* A lifetime history of treatment for bipolar disorder or schizophrenia
* Hospital admission or emergency department visit for suicidal symptoms in the past year
* Lack capacity to provide informed consent

Primary outcomes:
measure: Depression symptom response 12 weeks
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Antidepressant adherence
timeFrame: 6 and 12 weeks
measure: Depression symptom response 6 weeks
timeFrame: 6 weeks from baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References: