Depression
Conditions
Keywords
Medication adherence
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALArm 1 intervention
This description is blinded.
BEHAVIORALArm 2 Intervention
This description is blinded
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptom response 12 weeks | 12 weeks from baseline | A reduction of 50% in depression score from baseline as assessed by PHQ-9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactSteven C Marcus, PhD
Outcome results
None listed