Three-arm randomised controlled trial of text message reminders and financial incentives to improve antidepressant adherence among adults in primary care with depression: study protocol.

introductionAntidepressant medications are an effective treatment for major depressive disorder, yet antidepressant discontinuation early in the course of treatment remains common. Almost three-quarters of patients who are treated for depression receive their treatment exclusively from primary care providers who have relatively short visits with their depressed patients and little capacity to monitor their treatment adherence. There is a critical need to develop effective, low barrier strategies to support and promote antidepressant adherence for patients seen in primary care. We are conducting a 3-arm randomised controlled trial to compare the effectiveness of two adherence support strategies with usual care among adult primary care patients with depression who have been newly prescribed antidepressant medications. METHODS AND ANALYSIS: We are examining whether daily text messages with and without financial incentives improve depression symptoms and antidepressant adherence as compared with treatment as usual, assessed via wireless pill bottle and survey administration at 6 and 12 weeks. The primary outcome is symptom response at 12 weeks, defined as a ≥50% reduction from baseline depression symptom severity as measured by the Patient Health Questionnaire 9. Secondary outcomes include symptom response at 6 weeks and daily antidepressant adherence at 6 and 12 weeks. ETHICS AND DISSEMINATION: This study is registered on clinicaltrials.gov and has been approved by the University of Pennsylvania Institutional Review Board (#856160). All subjects provide informed consent to participate in research procedures prior to enrolment. Trial results will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT06496646.