Centre for Global Mental Health, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, United Kingdom.
Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.
JAMA. 2021 May 11;325(18):1852-1862. doi: 10.1001/jama.2021.4348.
Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown.
To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension.
DESIGN, SETTING, AND PARTICIPANTS: Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018).
An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima).
The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months.
Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant.
In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months.
ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).
抑郁症是导致全球疾病负担的主要原因之一。数字心理健康干预措施可以解决中低收入国家的治疗缺口，但这些国家的效果尚不清楚。
研究数字干预措施在降低患有糖尿病和/或高血压的人群中抑郁症状的有效性。
设计、设置和参与者：在巴西圣保罗的 20 个地点（N=880；从 2016 年 9 月至 2017 年 9 月；最终随访，2018 年 4 月）和秘鲁利马的 7 个地点（N=432；从 2017 年 1 月至 2017 年 9 月；最终随访，2018 年 3 月）进行了一项以行为激活原则为基础的、为期 6 周的 18 节、低强度的数字干预，由经过培训的护士助理提供智能手机，对 880 名患有临床显著抑郁症状（PHQ-9 评分≥10）的参与者进行分组随机对照试验（RCT），并对 440 名参与者进行强化常规护理（在巴西的 10 个组中各有 440 名参与者；在利马的 10 个组中各有 215 名参与者）。
主要结果是在 3 个月时 PHQ-9 评分至少降低 50%（范围为 0-27；得分越高表示抑郁程度越严重）。次要结果包括在 6 个月时 PHQ-9 评分至少降低 50%。
在巴西的 880 名参与者中，有 807 名（91.7%）完成了至少 1 次随访评估，在秘鲁的 432 名参与者中，有 426 名（98.6%）完成了至少 1 次随访评估。在巴西的 391 名参与者中，数字干预组中有 40.7%（159 名）的 PHQ-9 评分至少降低了 50%，而增强常规护理组中有 28.6%（114 名）（差异为 12.1 个百分点[95%置信区间，5.5 到 18.7]；调整后的优势比[OR]，1.6[95%置信区间，1.2 到 2.2]；P=0.001）。在利马，数字干预组中有 52.7%（108 名）的 PHQ-9 评分至少降低了 50%，而增强常规护理组中有 34.1%（70 名）（差异为 18.6 个百分点[95%置信区间，9.1 到 28.0]；调整后的 OR，2.1[95%置信区间，1.4 到 3.2]；P<0.001）。在 6 个月的随访中，组间差异不再具有统计学意义。
在巴西和秘鲁的两项 RCT 中，患有高血压或糖尿病且伴有抑郁症状的患者接受为期 6 周的数字干预，与增强常规护理相比，在 3 个月时显著改善了抑郁症状。然而，在巴西的试验中，效果的幅度较小，且在 6 个月时没有持续。
ClinicalTrials.gov：NCT02846662（圣保罗）和 NCT03026426（利马）。
