自然使用数字心理健康干预治疗抑郁和焦虑：一项随机临床试验。

Naturalistic use of a digital mental health intervention for depression and anxiety: A randomized clinical trial.

机构信息

Department of Psychology, University of Nevada, Las Vegas, NV, USA.

出版信息

J Affect Disord. 2025 Jan 1;368:429-438. doi: 10.1016/j.jad.2024.09.104. Epub 2024 Sep 17.

DOI:10.1016/j.jad.2024.09.104

PMID:39299591

Abstract

BACKGROUND

Digital mental health interventions (DMHI) may offer scalable treatment for common mental health conditions. However, many commercially available apps have not been subjected to rigorous evaluation of effectiveness, particularly among users experiencing clinically significant symptomatology. We examined depression and anxiety symptom outcomes associated with a top-rated, commercially available self-guided DMHI based on cognitive behavioral therapy ("Sanvello") relative to waitlist control.

METHODS

This preregistered web-based, 2-arm, parallel-group randomized trial enrolled U.S. adults with self-reported elevated symptoms of depression and/or anxiety. Those assigned to the treatment condition were provided 8 weeks of access to Sanvello. Co-primary outcomes of depression (Patient Health Questionnaire [PHQ-9]) and anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7]) severity were assessed at baseline and 2, 4, 6, and 8 weeks.

RESULTS

Intention-to-treat analyses included 280 participants (mean age 32.47 ± 9.32 years; 86.1 % women). Generalized linear mixed models showed a significant improvement in depression (F(4,779) = 6.51, p < .001) and anxiety (F(4,907) = 3.28, p = .01) associated with the DMHI over time. The intervention was also associated with a greater proportion of participants exhibiting depression response (25 [45.5 %] vs 26 [16.9 %]) and remission (10 [18.2 %] vs 7 [4.5 %]) on the PHQ-9, and anxiety response (31 [44.9 %] vs 39 [22.8 %]) and remission (20 [29.0 %] vs 27 [15.8 %]) on the GAD-7, relative to waitlist.

LIMITATIONS

Findings may not represent people with serious mental illness, suicidality, or the broader population of DMHI users.

CONCLUSIONS

A commercially available, self-guided DMHI was effective at improving symptoms in individuals experiencing depression or anxiety.

TRIAL REGISTRATION

ClinicalTrials.gov [NCT05373329].

摘要

背景

数字心理健康干预（DMHI）可能为常见心理健康状况提供可扩展的治疗方法。然而，许多市售应用程序尚未经过有效性的严格评估，特别是在经历临床显著症状的用户中。我们研究了基于认知行为疗法的一款顶级市售自我指导 DMHI（“Sanvello”）与候补名单对照相关的抑郁和焦虑症状结果。

方法

这项预先注册的基于网络的、2 臂、平行组随机试验招募了美国自报有抑郁和/或焦虑症状升高的成年人。被分配到治疗组的人将获得 8 周的 Sanvello 访问权限。抑郁（患者健康问卷 [PHQ-9]）和焦虑（广泛性焦虑障碍 7 项量表 [GAD-7]）严重程度的共同主要结局在基线和 2、4、6 和 8 周进行评估。

结果

意向治疗分析包括 280 名参与者（平均年龄 32.47±9.32 岁；86.1%女性）。广义线性混合模型显示，DMHI 随时间推移对抑郁（F(4,779)=6.51，p<.001）和焦虑（F(4,907)=3.28，p=.01）有显著改善。该干预措施还与更多的参与者在 PHQ-9 上表现出抑郁反应（25 [45.5%] 比 26 [16.9%]）和缓解（10 [18.2%] 比 7 [4.5%]）以及在 GAD-7 上表现出焦虑反应（31 [44.9%] 比 39 [22.8%]）和缓解（20 [29.0%] 比 27 [15.8%]）的比例更高，而不是候补名单。