Literature Collection

IMPORTANCE: More than two-thirds of US adults who screen positive for depression in the primary care setting do not receive treatment. These adults need evidence-based and scalable interventions. OBJECTIVE: To determine the effectiveness of Moodivate, a self-directed digital intervention for mental health, in treating depression symptoms among patients in the primary care setting. DESIGN, SETTING, AND PARTICIPANTS: This 3-group decentralized randomized clinical trial recruited participants from September 22, 2021, to December 27, 2023, and completed data collection on March 29, 2024. Adult patients with at least moderate symptoms of depression on the Patient Health Questionnaire-9 (score ≥10) were enrolled from 22 primary care clinics in South Carolina. INTERVENTIONS: Participants received Moodivate (a digital behavioral activation intervention), Moodivate with health care provider access to information on patient use of the digital behavioral activation intervention in the electronic health record (EHR), or usual care for depression. MAIN OUTCOMES AND MEASURES: The primary outcome was a change in depression symptoms on the Beck Depression Inventory-II (BDI-II) over 12 weeks. Secondary outcomes included a clinically significant improvement in depression symptoms on the BDI-II (10-point decrease in score), depression remission on the BDI-II (score ≤13), digital behavioral activation intervention engagement, and primary care provider (a physician or other health care professional who is responsible for a patient's primary care) use of the EHR features. RESULTS: Among 649 participants, 495 (76%) were female and the mean (SD) age was 44.68 (15.22) years. Participants who received the digital behavioral activation intervention, with and without EHR integration, had significantly improved depression symptoms vs those who received usual care over 12 weeks (least squares mean change from baseline for Moodivate: -10.34; SE = 0.82; d = 0.98; Moodivate with EHR: -9.88; SE = 0.81; d = 0.93; usual care: -5.94; SE = -0.80; d = 0.54). Participants in the Moodivate groups had 2.5 to 3.0 times higher odds of having a clinically significant improvement in depression symptoms (Moodivate: OR, 2.98 [97.5% CI, 1.69-5.27]; P < .001; Moodivate with EHR: OR, 2.53 [97.5% CI, 1.45-4.41]; P < .001) and 2.3 to 2.6 times higher odds of experiencing depression remission (Moodivate: OR, 2.27 [97.5% CI, 1.16-4.44; P = .006; Moodivate with EHR: OR, 2.63 [97.5% CI, 1.38-5.04]; P < .001) than participants who received usual care. Participant engagement with Moodivate was high in the first month (68% to 100% weekly retention), and 33% of patients continued to use the digital behavioral activation intervention after 12 weeks. Fourteen percent of primary care providers who received access used the EHR functionality. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that a digital behavioral activation intervention is effective for treating adults with at least moderate symptoms of depression in the primary care setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04463914.