IntelliCare in College Students (ICCS)
2020年9月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
時間枠：Week 4
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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
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Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
時間枠：Week 8
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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
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GAD-7 (Generalized Anxiety Disorder Scale-7)
時間枠：Week 4
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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.
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Week 4
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GAD-7 (Generalized Anxiety Disorder Scale-7)
時間枠：Week 8
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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.
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Week 8
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Anxiety Literacy Questionnaire
時間枠：Week 4
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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.
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Week 4
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Anxiety Literacy Questionnaire
時間枠：Week 8
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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.
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Week 8
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Depression Literacy Questionnaire
時間枠：Week 4
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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
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Week 4
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Depression Literacy Questionnaire
時間枠：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
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Week 8
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Cognitive and Behavioral Response to Stress Scale
時間枠：Week 4
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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.
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Week 4
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The Cognitive and Behavioral Response to Stress Scale
時間枠：Week 8
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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.
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Week 8
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Mean Number of Treatment App Use Sessions
時間枠：Daily for two months
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Daily for two months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年7月8日
一次修了 (実際)
2019年11月5日
研究の完了 (実際)
2019年11月5日
試験登録日
最初に提出
2019年7月23日
QC基準を満たした最初の提出物
2019年7月25日
最初の投稿 (実際)
2019年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月8日
QC基準を満たした最後の更新が送信されました
2020年9月14日
最終確認日
2020年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Mobile self-help interventionの臨床試験
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University of California, Los AngelesNational Institute on Drug Abuse (NIDA); Medical University of South Carolina; University of Arkansas募集