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临床试验/NCT01358487
NCT01358487已完成不适用

Internet Intervention to Prevent Major Depressive Episodes

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2011年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
2
主要终点
PHQ-9

研究概览

简要总结

The purpose of the study is:

  1. to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate in an online study to prevent clinical depression and
  2. to estimate the percentage of participants who will complete online assessments at 1, 3, and 6 months when receiving either a) email reminders + monetary online incentives or b) email reminders + monetary incentives + phone calls.

NOTE: RECRUITMENT IS COMPLETED.

详细描述

In 2002, NIMH released an initiative that called upon researchers to improve psychosocial interventions for unipolar and bipolar depression. The Workgroup charged with this task recommended that researchers consider the "development of interventions that PREVENT onset and recurrence of clinical episodes in at-risk populations and [the] development of user-friendly interventions and nontraditional delivery methods to increase access to evidence-based interventions" (Hollon et al., 2002, p. 610). The overall goal of this research program aims to address these two priorities by adapting an empirically-validated depression intervention to the Internet. The current research study will eventually provide an online site to study whether clinical episodes of depression can be prevented by making the online Website available to people who are NOT currently depressed, but may be at risk for depression.

Study 1: the NIMH-funded pilot study. For Study 1, the investigators will conduct usability testing with 60 participants (half English-speaking and half Spanish-speaking) recruited at San Francisco General Hospital with the sole purpose of providing feedback on the Healthy Mood Management Project Website being developed. The investigators will not be testing the intervention itself on these usability testing participants.

The investigators will then recruit 150 participants (half English-speaking [NOW COMPLETED] and half Spanish-speaking [STILL RECRUITING]) WHO ARE NOT CURRENTLY DEPRESSED to use the Healthy Mood Management Project Website online. In this part of the study the investigators will compare follow-up completion rates obtained by (email reminders + monetary incentives) versus (email reminders + monetary incentives + phone call follow-ups). All participants will get automatic email reminders with links to return to the study site to fill out FU surveys at 1, 3, and 6 months. All participants will also be offered monetary incentives that can be obtained online. In addition, half of the participants (chosen at random) will receive phone calls if they do not complete follow-up surveys online. This will allow us to determine whether the phone call follow-ups significantly improve follow-up rates.

The monetary incentives will be provided as online gift certificates to Amazon.com. The incentives will be provided by sending the participant a code which allows the user to purchase products (books, etc.) up to the amount provided.

The two groups to be compared are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • regular (>1 time/week) access to internet and email,
  • valid email address
  • fluent or almost fluent in English or Spanish [NOTE: ENGLISH RECRUITMENT COMPLETED. SPANISH RECRUITMENT CONTINUES]
  • looking for information to help themselves, rather than another person
  • must complete screening survey at the following Website: https://ihrc.ucsf.edu/Collector/Survey.ashx?Name=DPC_ScreenSurvey&SOURCE=Prev4

排除标准

  • less than 18 years of age
  • sporadic (<1 time/week) access to internet and email
  • no valid email address
  • not fluent in English or Spanish
  • looking for information to help someone else
  • currently suffering from serious depression and/or in treatment for depression (If you are currently depressed, consider applying for a related Internet study to manage serious depression symptoms by going to the following Website: https://ihrc.ucsf.edu/interventionConsole/Default.aspx?ConsoleName=DepressionManagementCourse)

研究组 & 干预措施

Online self-help mood management course

Active Comparator

Online self-help mood management course based on cognitive behavioral therapy and social cognitive theory, plus automated online follow ups using email reminders and incentives for completing follow-ups

干预措施: Online + incentives Follow-up Group (Behavioral)

Online self-help course plus live follow-up if needed

Experimental

Intervention and automated follow ups with incentives as in the active comparator condition. The experimental procedure is adding live phone follow-ups if participant does not complete online assessment surveys at 1, 3, and 6 months in response to automated emails.

干预措施: Online self-help course plus live follow-up if needed (Behavioral)

结局指标

主要结局

PHQ-9

时间窗: Baseline, 1, 3, and 6 months post consent

Screens for symptoms of major depressive episodes (MDE).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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