Dahne Jennifer, Wahlquist Amy E, Carpenter Matthew J, Graboyes Evan M, Lejuez Carl W, Kustanowitz Jacob, Natale Noelle, Levins Olivia, Player Marty, Diaz Vanessa A
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.
Hollings Cancer Center, Medical University of South Carolina, Charleston.
JAMA Intern Med. 2025 Apr 14. doi: 10.1001/jamainternmed.2025.0494.
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04463914.
在美国初级保健机构中筛查出抑郁症呈阳性的成年人中，超过三分之二未接受治疗。这些成年人需要基于证据且可扩展的干预措施。
确定Moodivate（一种针对心理健康的自我导向数字干预措施）在治疗初级保健机构患者抑郁症状方面的有效性。
设计、设置和参与者：这项三组去中心化随机临床试验于2021年9月22日至2023年12月27日招募参与者，并于2024年3月29日完成数据收集。从南卡罗来纳州的22家初级保健诊所招募了在患者健康问卷-9上至少有中度抑郁症状（得分≥10）的成年患者。
参与者接受Moodivate（一种数字行为激活干预措施）、可让医疗保健提供者在电子健康记录（EHR）中获取患者使用数字行为激活干预措施信息的Moodivate，或抑郁症常规护理。
主要结局是12周内贝克抑郁量表-II（BDI-II）上抑郁症状的变化。次要结局包括BDI-II上抑郁症状的临床显著改善（得分降低10分）、BDI-II上的抑郁缓解（得分≤13）、数字行为激活干预措施的参与度，以及初级保健提供者（负责患者初级保健的医生或其他医疗保健专业人员）对EHR功能的使用。
在649名参与者中，495名（76%）为女性，平均（标准差）年龄为44.68（15.22）岁。在12周内，接受数字行为激活干预措施（无论是否与EHR整合）的参与者与接受常规护理的参与者相比，抑郁症状有显著改善（Moodivate从基线的最小二乘均值变化：-10.34；标准误=0.82；d=0.98；与EHR整合的Moodivate：-9.88；标准误=0.81；d=0.93；常规护理：-5.94；标准误=-0.80；d=0.54）。Moodivate组的参与者在抑郁症状上有临床显著改善的几率比接受常规护理的参与者高2.5至3.0倍（Moodivate：比值比，2.98[97.5%置信区间，1.69-5.27]；P<.001；与EHR整合的Moodivate：比值比，2.53[97.5%置信区间，1.45-4.41]；P<.001），经历抑郁缓解的几率高2.3至2.6倍（Moodivate：比值比，2.27[97.5%置信区间，1.16-4.44；P=.006；与EHR整合的Moodivate：比值比，2.63[97.5%置信区间，1.38-5.04]；P<.001）。参与者在第一个月对Moodivate的参与度很高（每周留存率为68%至100%），12周后33%的患者继续使用数字行为激活干预措施。获得访问权限的初级保健提供者中有14%使用了EHR功能。
这项随机临床试验发现，数字行为激活干预措施对治疗初级保健机构中至少有中度抑郁症状的成年人有效。
ClinicalTrials.gov标识符：NCT04463914。
