Antidepressant Adherence for Depressed Adults in Primary Care

Not Applicable

Not yet recruiting

• Conditions: Depression
• Interventions: Behavioral: Reminders; Behavioral: Incentives

• Registration Number: NCT06496646
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Study Start: 2025-02-01
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 525

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reminders Alone	Reminders	This group will receive 12 weeks of personalized daily text reminders without financial incentives.
Reminders and Incentives	Reminders	This group will receive 12 weeks of personalized daily text reminders paired with 6 weeks of financial incentives.
Reminders and Incentives	Incentives	This group will receive 12 weeks of personalized daily text reminders paired with 6 weeks of financial incentives.

Primary Outcome Measures

Name	Time	Method
Depression symptom response 12 weeks	12 weeks from baseline	A reduction of 50% in depression score from baseline as assessed by PHQ-9

Secondary Outcome Measures

Name	Time	Method
Antidepressant adherence	6 and 12 weeks	measurement of antidepressant adherence through electronic pill bottles
Depression symptom response 6 weeks	6 weeks from baseline	A reduction of 50% in depression score from baseline as assessed by PHQ-9