Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
2021年5月5日 更新者：Fiona YY Ho、Chinese University of Hong Kong
Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial
This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression.
Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants.
Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1.
The randomization will be performed by an independent assessor using a computer-generated list of numbers.
In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial.
Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19).
The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer.
The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments.
Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed.
In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.
調査の概要
研究の種類
介入
入学 (予想される)
90
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。
研究連絡先
- 名前：Vincent Wing-Hei Wong
- 電話番号：+852 39436575
- メール：vincentwongWH@link.cuhk.edu.hk
研究場所
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Sha Tin、香港
- The Chinese University of Hong Kong
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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
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Hong Kong residents aged ≥ 18 years
- Cantonese language fluency and readability
- A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
- Possession of an internet-enabled mobile device (iOS or Android operating system)
- Willingness to provide informed consent and comply with the trial protocol
Exclusion Criteria:
- Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
- Any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
- Current involvement in lifestyle changes supervised by professionals
- Unstable medication or current participation in any psychotherapy for depression
- Pregnancy
- Hospitalization
- Current participation in any other trial(s)
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：自己追跡ツールによる生活習慣病への介入
食事、睡眠、運動、リラクゼーション、マインドフルネスなどのライフスタイルへの介入。
スマートフォンアプリやアクティグラフィーなどの自己追跡ツールが提供されます。
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食事、睡眠、運動、リラクゼーション、マインドフルネスなどの生活習慣への介入
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実験的：純粋な生活習慣病の介入
食事、睡眠、運動、リラクゼーション、マインドフルネスなどのライフスタイルへの介入。
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食事、睡眠、運動、リラクゼーション、マインドフルネスなどの生活習慣への介入
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介入なし：いつも通りのケア
通常どおり定期的なケアを受け続け、フォローアップ評価の完了後にスマートフォンベースのLM介入を受ける
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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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Change in the Patient Health Questionnaire (PHQ-9)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in Insomnia Severity Index (ISI)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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ISI is a 7-item scale designed to evaluate perceived insomnia severity.
Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health.
The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines.
A higher score indicated a better QoL.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in the Health-Promoting Lifestyle Profile (HPLP II)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in the Sheehan Disability Scale (SDS)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
時間枠：Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version a short form of the IPAQ-C.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the Credibility-Expectancy Questionnaire (CEQ)
時間枠：Baseline and immediately after treatment
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The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
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Baseline and immediately after treatment
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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。
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 (予想される)
2021年7月1日
一次修了 (予想される)
2022年5月31日
研究の完了 (予想される)
2022年6月30日
試験登録日
最初に提出
2021年5月5日
QC基準を満たした最初の提出物
2021年5月5日
最初の投稿 (実際)
2021年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月6日
QC基準を満たした最後の更新が送信されました
2021年5月5日
最終確認日
2021年5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。