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广泛性焦虑症患者基于网络的自助干预评估：一项随机对照试验方案

Evaluation of a Web-Based Self-Help Intervention for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial.

作者信息

Rubel Julian, Quest Jannis, Pruessner Luise, Timm Christina, Hartmann Steffen, Barnow Sven, Rittmeyer Lisa, Rosenbaum David, Lalk Christopher

机构信息

Faculty of Psychology and Sport Science, Justus-Liebig-University Giessen, Gießen, Germany.

Faculty of Behavioral and Empirical Cultural Studies, Heidelberg University, Heidelberg, Germany.

出版信息

JMIR Res Protoc. 2023 Jul 26;12:e41440. doi: 10.2196/41440.

DOI:10.2196/41440

PMID:37494105

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10413245/

Abstract

BACKGROUND

Generalized anxiety disorder (GAD) is a highly prevalent and severely distressing condition that can lead to functional impairments and is considered one of the most difficult anxiety disorders to treat. Following new technological developments, a highly structured cognitive behavioral therapy (CBT) approach that has already shown success in face-to-face psychotherapy can be implemented: internet-delivered CBT (iCBT). There is now evidence for the efficacy of both guided and unguided iCBT interventions for GAD regarding symptom reduction.

OBJECTIVE

To establish the usefulness of such interventions, we plan to evaluate the efficacy of a web-based self-help program (Selfapy) for GAD in a relatively large sample. We aim to assess effects beyond symptom reduction, including effects on well-being, functioning, and mental health literacy, as well as the effect on health care burden, while testing the intervention in conditions comparable to routine care.

METHODS

Patients (n=156) who have been diagnosed with GAD, are aged between 18 and 65 years, have internet access, and have sufficient German language skills will be recruited for this study. The intervention group (n=78) will receive access to the 12-week self-help web-based program Selfapy. The waitlist control group (n=78) will receive no intervention in the context of the study. However, both groups will be allowed to access further health care services (eg, psychotherapy, medication), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1) and 6 weeks (T2) and 12 weeks (T3) after the start of the intervention. The primary outcome will be generalized anxiety symptoms and quality of life at T3. Additional outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and negative effects.

RESULTS

By May 2023, all participants had finished the trial and the report was being prepared for publication.

CONCLUSIONS

Web-based interventions may be an important addition to the German health care system to reduce barriers to treatment access. Further, they may prove cost-effective for the treatment of GAD.

TRIAL REGISTRATION

Deutsches Register Klinischer Studien DRKS00023799; https://tinyurl.com/22bds38x.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41440.

摘要

背景

广泛性焦虑障碍（GAD）是一种高度普遍且令人极度痛苦的疾病，可导致功能受损，被认为是最难治疗的焦虑症之一。随着新技术的发展，可以实施一种高度结构化的认知行为疗法（CBT）方法，这种方法在面对面心理治疗中已显示出成效：互联网提供的CBT（iCBT）。现在有证据表明，有指导和无指导的iCBT干预对GAD减轻症状均有效。

目的

为确定此类干预措施的有效性，我们计划在一个相对较大的样本中评估一种基于网络的GAD自助项目（Selfapy）的疗效。我们旨在评估除减轻症状之外的效果，包括对幸福感、功能和心理健康素养的影响，以及对医疗负担的影响，同时在与常规护理相当的条件下测试该干预措施。

方法

本研究将招募已被诊断为GAD、年龄在18至65岁之间、能上网且具备足够德语能力的患者（n = 156）。干预组（n = 78）将有权限使用为期12周基于网络的自助项目Selfapy。等待名单对照组（n = 78）在研究期间将不接受干预。然而，两组都将被允许获得进一步的医疗服务（如心理治疗、药物治疗），这反映了德国目前的常规护理情况。将在干预开始后的基线（T1）、6周（T2）和12周（T3）评估结果指标。主要结果将是T3时的广泛性焦虑症状和生活质量。其他结果包括抑郁、工作能力、与治疗相关的费用和负担、健康素养以及负面影响。