Background: Available smartphone-based interventions for depression predominantly use evidence-based strategies from cognitive-behavioral therapy (CBT), but patient engagement and reported effect sizes are small. Recently, studies have demonstrated that smartphone-based interventions combining CBT with gamified approach-avoidance bias modification training (AAMT) can foster patient engagement and reduce symptoms of several mental health problems. Objective: Based on these findings, we developed a gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), and hypothesized the program would both engage patients and produce preliminary evidence for the reduction of depressive symptoms. Methods: To test this hypothesis, we evaluated MT-Phoenix in a randomized controlled pilot trial including 77 individuals with elevated depression scores (Patient Health Questionnaire-9 scores ≥5). Participants were either instructed to train for 14 days with MT-Phoenix or assigned to a waitlist control condition. Engagement with the intervention was measured by assessing usage data. The primary outcome was reduction in depressive symptom severity at postassessment. Results: Data from this pilot trial shows that participants in the intervention group used the smartphone-based intervention for 46% of all days (6.4/14) and reported a significantly greater reduction of depressive symptoms than did participants in the control condition (F_1,74=19.34; P=.001), with a large effect size (d=1.02). Effects were sustained at a 3-month follow-up. Conclusions: A gamified smartphone-based intervention combining CBT with AAMT may foster patient engagement and effectively target depressive symptoms. Future studies should evaluate the effectiveness of this intervention in a phase 3 trial using clinical samples. Moreover, the intervention should be compared to active control conditions. Trial Registration: German Clinical Trial Registry DRKS00012769; https://tinyurl.com/47mw8du7

中文翻译：

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基于游戏化智能手机的抑郁症干预措施：随机对照试验

背景：现有的基于智能手机的抑郁症干预措施主要使用来自认知行为疗法 (CBT) 的循证策略，但患者参与度和报告的效果规模很小。最近，研究表明，基于智能手机的干预将 CBT 与游戏化方法避免偏见修正训练 (AAMT) 相结合，可以促进患者参与并减少多种心理健康问题的症状。目标：基于这些发现，我们开发了一种游戏化的基于智能手机的干预措施，mentalis Phoenix (MT-Phoenix)，并假设该计划既能吸引患者，又能产生减轻抑郁症状的初步证据。方法：为了验证这一假设，我们在一项随机对照试验中对 MT-Phoenix 进行了评估，该试验包括 77 名抑郁评分升高的个体（患者健康问卷 9 评分≥5）。参与者要么被指示用 MT-Phoenix 训练 14 天，要么被分配到候补名单控制条件。通过评估使用数据来衡量干预的参与度。主要结果是评估后抑郁症状严重程度的降低。结果：该试点试验的数据显示，干预组的参与者在所有天数的 46% (6.4/14) 中使用了基于智能手机的干预，并且报告的抑郁症状比对照条件下的参与者显着减少 ( F _{1 ,74} =19.34; P=.001)，具有较大的效应量 ( d =1.02)。效果在 3 个月的随访中得以持续。结论：将 CBT 与 AAMT 相结合的基于游戏化的智能手机干预可以促进患者参与并有效地针对抑郁症状。未来的研究应该使用临床样本在 3 期试验中评估这种干预措施的有效性。此外，干预应与主动控制条件进行比较。试验注册：德国临床试验注册中心 DRKS00012769；https://tinyurl.com/47mw8du7