此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)

2018年9月7日 更新者:Silver Cloud Health

A Pilot Study Investigating the Feasibility of Implementing Internet-delivered Treatments for Depression and Anxiety in Primary Care

The current study is an open feasibility trial with the aim of providing a description of the factors associated with the implementation of an iCBT platform into an existing treatment framework in a primary care setting. The trial will examine the factors surrounding implementation, such as the experience of primary care practitioners and the online supporters, the recruitment process, and attitudes towards the overall implementation of the interventions. Patients presenting to the primary care setting will be screened using standard depression and anxiety measures, and where appropriate, will be referred to an iCBT intervention for either depression or anxiety, with support from trained staff. Analyses will be conducted on outcome measures to examine changes in symptom severity as patients progress through the intervention. Patient satisfaction data will also be collected to establish patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at Ohio Family Practice Center]

研究概览

详细说明

iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety. Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered with poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option.

Approximately 90% of primary care patients with depression have one or more visits to a primary care physician (PCP) over a 12-month period, whereas less than one-third see a mental health professional. It has been reported that individuals with an anxiety disorder are 3 to 5 times more likely to visit their primary care physician than those without, but their symptoms are often associated with physical causes. PCPs often do not have training in psychological therapies and therefore they do not feel competent to treat individuals presenting with depression or anxiety. Often these individuals are prescribed antidepressant or anti-anxiety medications.

The use of online programs to deliver CBT to people with mental health disorders is becoming increasingly popular. Internet-delivered CBT (iCBT) consists of programs designed for the treatment of specific disorders, such as depression and anxiety, which are delivered via the internet. These programs can be clinician-guided and/or self-administered interventions. Evidence suggests that iCBT can benefit individuals with anxiety and depression when offered in a service context that offers brief support from trained staff. Such iCBT interventions are widely-used in some European countries and the recommended length of treatment is generally 6 - 8 online sessions. A robust evidence base supporting the use and effectiveness of internet-delivered treatments for depression and anxiety has been established. Outcomes have been greater for those programs offering the additional feature of human support.

The current study will examine the feasibility of implementing an iCBT platform within a primary care setting. This objective can be further dismantled into several sub objectives:

  1. Is the model of implementation (screening, recruitment, and adherence to the internet-delivered intervention) feasible?
  2. Will patients experience the iCBT intervention as satisfactory within their primary care treatment?
  3. What is the feedback of the Primary Care Practitioners about the implementation of the internet-delivered intervention as part of primary care?
  4. What is the experience of the trained supporters who assist patients within the iCBT intervention?
  5. Can an internet-delivered intervention achieve improvements in depressive and anxiety symptoms for users?
  6. Can patient attitudes toward internet-delivered interventions predict treatment outcome?

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Akron、Ohio、美国、44310
        • Summa Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

At least 18 years of age, Speak English, Self-report symptoms of depression or anxiety (using PHQ-9 and GAD-7 measures).

Specifically for the self-report symptoms,

participants will need to have a PHQ-9 score of 5 to 19 for the depression program or a GAD-7 score of 5 to 15 for the anxiety program.

Participants currently attending face-to-face therapy/counseling will be excluded.

Exclusion criteria

Participants who flag as a risk on the self-harm item of the PHQ-9 during routine office visit screening will not be referred to the study and will be provided treatment and/or referral services as per the clinic's standard procedure.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Space from depression
Space from Depression is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
internet-delivered CBT
实验性的:Space from Anxiety
Space from Anxiety is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
internet-delivered CBT

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient health Questionnaire
大体时间:At week 8
The PHQ-9 is a self-report measure of depression that has been widely used in screening, primary care, and research. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association [APA], 2000). Summed scores range from 0-27; larger scores reflect a greater severity of depressive symptoms. The PHQ-9 discriminated well between depressed and nondepressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%) and specificity (88.0%) (Kroenke et al., 2001; R. Spitzer et al., 1999).
At week 8
Generalized Anxiety Disorder
大体时间:At week 8
The GAD-7 (Spitzer, Krownke, Williams, & Lowe, 2006) comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD. The GAD-7 has good internal consistency (.89) and good convergent validity with other anxiety scales. Higher scores indicate greater severity of symptoms. The GAD-7 is increasingly used in large-scale studies as a generic measure of changes in anxiety symptomatology, using a cut-off score of 8 (Richards & Suckling, 2009).
At week 8

次要结果测量

结果测量
措施说明
大体时间
Socio-demographic Questionnaire
大体时间:At baseline for screening
Collects information on the characteristics of the sample including age, gender etc.
At baseline for screening
Work and Social Adjustment
大体时间:At baseline and week 8
The Work and Social Adjustment (WASA; Mundt, Marks, Shear, & Greist, 2002) is a simple, reliable and valid measure of impaired functioning. It is a simple and reliable (α >.75) 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships.
At baseline and week 8
Satisfaction with Treatment
大体时间:At week 8
The Satisfaction with Treatment (SAT; Timulak & Richards, 2012) measure contains several questions that aim to assess patient satisfaction with the iCBT intervention received. The measure consists of 2 qualitative questions and several quantitative questions, centring on what the patients liked or disliked about the iCBT intervention.
At week 8
Attitudes towards Psychological Online Interventions
大体时间:At baseline and week 8
The Attitudes towards Psychological Online Interventions (APOI; Schroder et al., 2015) will be administered to patients at both pre and post intervention time points. The APOI is a brief inventory that assesses attitudes towards online interventions across four domains - scepticism and perception of risks, confidence in effectiveness, technologization threat and anonymity benefits.
At baseline and week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月8日

初级完成 (实际的)

2018年2月8日

研究完成 (实际的)

2018年2月9日

研究注册日期

首次提交

2017年2月21日

首先提交符合 QC 标准的

2017年2月24日

首次发布 (实际的)

2017年3月3日

研究记录更新

最后更新发布 (实际的)

2018年9月10日

上次提交的符合 QC 标准的更新

2018年9月7日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅