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临床试验/NCT04108429
NCT04108429已完成不适用

Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study

Northwestern University2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2020年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
2
主要终点
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

研究概览

简要总结

This study is a hybrid effectiveness-implementation trial of the smartphone student stress-management app IntelliCare for college students. This intervention will be tested with University of Illinois at Chicago (UIC) and Northern Illinois University (NIU) students. During the study, participants will complete measures of depressive and anxious symptoms, as well as measures of mental health literacy, within the app.

详细描述

In this study, students will be recruited to use the IntelliCare Hub app and encouraged to use it daily.The overall aim of this study is to pilot the program, evaluation metrics, implementation strategies, data collection and assessment procedures for a larger implementation trial. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At monthly intervals, participants will be prompted within the app to complete the Depression Literacy Questionnaire and Anxiety Literacy Questionnaire to measure mental health literacy, the Knowledge and Beliefs about Services scale to measure knowledge of campus mental health services, the Barriers to Mental Health Help-Seeking questionnaire to measure treatment barriers, and the Cognitive and Behavioral Response to Stress Scale to measure cognitive and behavioral coping skills. Counseling center utilization data will be extracted from the participating counseling centers' electronic medical records.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Participant is a student at the University of Illinois in Chicago or Northern Illinois University. *Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
  • Participant is 18 years of age or older

排除标准

  • 未提供

结局指标

主要结局

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

时间窗: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe

Average Number of Days of App Usage

时间窗: Days of app use through study completion, up to 10 months

The mean number of days the app was used was drawn from the study app over the course of the study

Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)

时间窗: Biweekly session utilization from August 1, 2018 (start of pre-implementation data collection; prior to the implementation trial) to December 18, 2020 (end of implementation period)

Counseling session utilization data were examined on a biweekly basis to determine if the introduction of the IntelliCare for College Students program impacts counseling center utilization. Counts of types of sessions (e.g. intake appointments, individual counseling appointments, crisis appointments) attended by students were examined over time to look at potential changes. These data were collected from the university in aggregate, thus, there are not participant-level data.

Generalized Anxiety Disorder Scale - 7 (GAD-7)

时间窗: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.

次要结局

  • Depression Literacy Questionnaire(Monthly questionnaire scores at baseline, one month and two months)
  • Anxiety Literacy Questionnaire(Monthly questionnaire scores at baseline, one month and two months)
  • Cognitive and Behavioral Response to Stress Scale (CB-RSS)(Monthly questionnaire scores at baseline, one month and two months)

研究者

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

Emily G Lattie

Assistant Professor

Northwestern University

研究点 (2)

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