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临床试验/NCT03244878
NCT03244878已完成不适用

Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans

Montana State University2 个研究点 分布在 1 个国家目标入组 464 人开始时间: 2017年5月1日最近更新:
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
464
试验地点
2
主要终点
Patient Health Questionnaire-9

研究概览

简要总结

This study evaluates a culturally-modified version of Thrive, a computerized Cognitive Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural Montanans. Study participants will be randomized to either a wait-list treatment as usual or the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary assessment measure is the Patient Health Questionnaire-9.

详细描述

Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression.

Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.

The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Baseline PHQ-9 score of 5 or greater
  • Montana resident
  • Regular access to broadband internet (streaming capability)

排除标准

  • No broadband internet access
  • Aged 17 years or younger
  • Does not have Montana residency
  • Baseline PHQ-9 score of < 5

研究组 & 干预措施

Intervention - Thrive program

Experimental

Participants will receive access to the Thrive program for 8 weeks

干预措施: Thrive (Behavioral)

Wait-list Control

No Intervention

Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.

结局指标

主要结局

Patient Health Questionnaire-9

时间窗: 2 weeks

Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)

次要结局

  • Generalized Anxiety Disorder-7(2 weeks)
  • Work and Social Adjustment Scale(1 year)
  • Connor-Davidson Resilience Scale(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark B. Schure, Ph.D.

Assistant Professor

Montana State University

研究点 (2)

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