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临床试验/NCT05551702
NCT05551702已完成不适用

Treating Depression With Text Delivered Counseling (Depression Study 2.0)

The University of Tennessee, Knoxville2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
2
主要终点
Change from Baseline Beck Depression Inventory II at 2 Months

研究概览

简要总结

The purpose of the research study is to investigate whether CBT-txt, a counseling program delivered by text messages is effective in stopping or reducing depressive symptoms. CBT-txt is based on a counseling program that has been proven to reduce depression when delivered in-person and on the web, but has not yet been tested or shown to be effective when delivered by text.

详细描述

After being informed about the study and potential risks, participants will complete online screening assessments. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the waitlist-control group. Those who are randomized to the intervention group will receive the 8-week text intervention via smartphone and complete assessments at baseline, 1 month, 2 months, and 3 months. Those who are randomized to the waitlist-control group will only complete the assessments at baseline, 1 month, 2 months, and 3 months. Participants who are initially assigned to the waitlist-control group can choose to receive the text intervention once their 3-month participation is complete.

研究设计

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

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 25 years old
  • a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms

排除标准

  • treatment for depression during the past three months
  • endorse suicide ideation on the PHQ-9*
  • lack of access to a text-capable phone
  • unable or unwilling to commit to two months of follow-up
  • not fluent in English.

结局指标

主要结局

Change from Baseline Beck Depression Inventory II at 2 Months

时间窗: Baseline, 1 Month, 2 Month, 3 Month

A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.

Change from Baseline Beck Depression Inventory II at 3 Months

时间窗: Baseline, 1 Month, 2 Month, 3 Month

A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.

次要结局

  • Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months(Baseline, 1 Month, 2 Months, 3 Months)
  • Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months(Baseline, 1 Month, 2 Months, 3 Months)
  • Change from Baseline Perseverative Thinking Questionnaire at 2 Months(Baseline, 1 Month, 2 Months, 3 Months)
  • Change from Baseline Perseverative Thinking Questionnaire at 3 Months(Baseline, 1 Month, 2 Months, 3 Months)
  • Change from Baseline Behavioral Activation for Depression Scale at 2 Months(Baseline, 1 Month, 2 Months, 3 Months)
  • Change from Baseline Behavioral Activation for Depression Scale at 3 Months(Baseline, 1 Month, 2 Months, 3 Months)

研究者

发起方
The University of Tennessee, Knoxville
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Mason

Principal Investigator

The University of Tennessee, Knoxville

研究点 (2)

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