IntelliCare in College Students (ICCS)
2020년 9월 14일 업데이트: Emily G Lattie, Northwestern University
Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
This study is an 8-week usability and feasibility 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 this period, research surveys assessing depression and anxiety can be completed on the app.
Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.
연구 개요
상세 설명
In this study, students will be recruited for an 8-week trial in which they will be given the IntelliCare Hub app and encouraged to use it daily.
To ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores > 10 on either the PHQ-9 or GAD-7 and 5 without elevated scores on either measure, for a total of 20 participants.
The rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants.
This trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use.
During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week.
At baseline, 4 weeks, and 8 weeks, 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.
At 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone.
This is to gain insight on the user's experience with the app.
연구 유형
중재적
등록 (실제)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60611
- Northwestern University
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
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
Exclusion Criteria:
None
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Extended usability of a mobile self-help intervention
Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks
|
During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8.
All participants will first undergo initial assessments that will include a series of online questionnaires about their mood.
Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management.
It is suggested that participants utilize the mobile phone tools every day
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
기간: Week 4
|
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe. |
Week 4
|
|
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
기간: Week 8
|
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe. |
Week 8
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
기간: Week 4
|
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.
|
Week 4
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
기간: Week 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.
|
Week 8
|
|
Anxiety Literacy Questionnaire
기간: Week 4
|
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
|
Week 4
|
|
Anxiety Literacy Questionnaire
기간: Week 8
|
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
|
Week 8
|
|
Depression Literacy Questionnaire
기간: Week 4
|
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
|
Week 4
|
|
Depression Literacy Questionnaire
기간: Week 8
|
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
|
Week 8
|
|
Cognitive and Behavioral Response to Stress Scale
기간: Week 4
|
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
|
Week 4
|
|
The Cognitive and Behavioral Response to Stress Scale
기간: Week 8
|
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
|
Week 8
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Mean Number of Treatment App Use Sessions
기간: Daily for two months
|
Daily for two months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 7월 8일
기본 완료 (실제)
2019년 11월 5일
연구 완료 (실제)
2019년 11월 5일
연구 등록 날짜
최초 제출
2019년 7월 23일
QC 기준을 충족하는 최초 제출
2019년 7월 25일
처음 게시됨 (실제)
2019년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 10월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 14일
마지막으로 확인됨
2020년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Mobile self-help intervention에 대한 임상 시험
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of Alberta; Child-Bright...완전한
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)완전한
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)완전한