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青少年抑郁症的自我引导式数字干预:可行性与初步疗效研究。

Self-Guided Digital Intervention for Depression in Adolescents: Feasibility and Preliminary Efficacy Study.

作者信息

Miller Ian, Peake Emily, Strauss Gabriel, Vierra Elise, Koepsell Xin, Shalchi Brandon, Padmanabhan Aarthi, Lake Jessica

机构信息

Limbix Health, Inc, San Francisco, CA, United States.

Big Health Inc, San Francisco, CA, United States.

出版信息

JMIR Form Res. 2023 Nov 22;7:e43260. doi: 10.2196/43260.

Abstract

BACKGROUND

Depression in adolescents is a large and growing problem; however, access to effective mental health care continues to be a challenge. Digitally based interventions may serve to bridge this access gap for adolescents in need of care. Digital interventions that deliver components of cognitive behavioral therapy (CBT) have been shown to reduce symptoms of depression, and virtual reality (VR) may be a promising adjunctive component. However, research on these types of treatments in adolescents and young adults is limited.

OBJECTIVE

This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0), a 5-week, self-guided, CBT-based digital program using a mobile app and VR experiences to target symptoms of depression in adolescents.

METHODS

A single-arm, open-label study of the Spark program was conducted with a community sample of 30 adolescents and young adults aged 12 to 21 years with self-reported moderate to severe depression symptoms. Participants completed a weekly depression assessment (Patient Health Questionnaire-8) in the app during the 5-week intervention period as well as web-based baseline, postintervention, and 1-month follow-up self-report assessments. The participants also completed a qualitative postintervention interview. For participants aged <18 years, caregivers completed assessments at baseline and postintervention time points. Feasibility outcomes included recruitment rate (the proportion of participants who enrolled in the study divided by the total number of participants screened for eligibility) and retention rate (the proportion of participants who completed postintervention assessments divided by the total number of participants who received the intervention). Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Preliminary efficacy was evaluated based on the Patient Health Questionnaire-8.

RESULTS

The study recruitment (31/66, 47%) and retention (29/30, 97%) rates were high. Participants provided higher ratings for the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, whereas they provided lower ratings for the program's ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at postintervention (mean difference 5.36; P<.001) and 1-month follow-up (mean difference 6.44; P<.001) time points.

CONCLUSIONS

The Spark program was found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents and young adults with symptoms of depression. Preliminary data also indicated that the Spark program reduced the symptoms of depression in adolescents and young adults. Future studies should evaluate the efficacy of this intervention in an adequately powered randomized controlled trial.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04165681; https://classic.clinicaltrials.gov/ct2/show/NCT04165681.

摘要

背景

青少年抑郁症是一个日益严重的大问题;然而,获得有效的心理健康护理仍然是一项挑战。基于数字技术的干预措施可能有助于为需要护理的青少年弥合这一获取差距。已证明提供认知行为疗法(CBT)组成部分的数字干预措施可减轻抑郁症状,虚拟现实(VR)可能是一个有前景的辅助组成部分。然而,针对青少年和青年的这类治疗方法的研究有限。

目的

本研究旨在评估Spark(v1.0)的可行性、可接受性和初步疗效,这是一个为期5周、自我引导、基于CBT的数字项目,使用移动应用程序和VR体验来针对青少年的抑郁症状。

方法

对Spark项目进行了一项单臂、开放标签研究,样本来自社区中30名年龄在12至21岁之间、自我报告有中度至重度抑郁症状的青少年和青年。参与者在为期5周的干预期内通过应用程序完成每周一次的抑郁评估(患者健康问卷 - 8),以及基于网络的基线、干预后和1个月随访的自我报告评估。参与者还完成了干预后的定性访谈。对于年龄小于18岁的参与者,照顾者在基线和干预后时间点完成评估。可行性结果包括招募率(参与研究的参与者比例除以筛选合格的参与者总数)和保留率(完成干预后评估的参与者比例除以接受干预的参与者总数)。可接受性结果包括对项目的参与度以及关于该项目的定量和定性反馈。基于患者健康问卷 - 8评估初步疗效。

结果

该研究的招募率(31/66,47%)和保留率(29/30,97%)很高。参与者对Spark项目的易用性给予了较高评分(满分10分,得8.76分),对该项目的移动应用程序(满分10分,得7.00分)和VR组件(满分10分,得7.48分)的喜爱程度也较高,而对该项目改善情绪的能力(满分10分,得4.38分)或融入日常生活的能力(满分10分,得5.69分)给予了较低评分。我们观察到在干预后(平均差异5.36;P <.001)和1个月随访(平均差异6.44;P <.001)时间点,抑郁评分在临床和统计学上有显著降低。

结论

发现Spark项目是一种可行且可接受的方式,能为有抑郁症状的青少年和青年提供以CBT为重点的自我引导干预。初步数据还表明,Spark项目减轻了青少年和青年的抑郁症状。未来的研究应在有足够样本量的随机对照试验中评估这种干预措施的疗效。

试验注册

ClinicalTrials.gov NCT04165681;https://classic.clinicaltrials.gov/ct2/show/NCT04165681

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5a4/10701656/8ab83eb8f875/formative_v7i1e43260_fig1.jpg

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