Antidepressant Adherence for Depressed Adults in Primary Care

University of Pennsylvania

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Arm 1 intervention; Behavioral: Arm 2 Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06496646

1R01MH135011-01A1

Details and patient eligibility

About

The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes.

Full description

Participants in the study will be given a special pill bottle for depression medication. This pill bottle will track how often the bottle is opened to take medication and it will transmit that information to the research team. Participation will last 12 weeks, and will include an initial assessments over the phone and follow-up assessments over the phone or electronically approximately 6 weeks and 12 weeks later. During these assessments, a research coordinator will ask questions about your mood, quality of life, participation in the management of depression, and related topics.

Enrollment: 525 estimated patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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
• English-speaking

Exclusion criteria

• Treated with antidepressants in the past 90 days
• Pregnant or breastfeeding
• 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
• Using antidepressant more than 10 days at baseline assessment

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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525 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Behavioral: Arm 1 intervention

Arm 2

Experimental group

Treatment:

Behavioral: Arm 2 Intervention

Behavioral: Arm 1 intervention

Arm 3

No Intervention group