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治験 NCT07010133（対象：うつ病、身体不活動）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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サンディエゴ州立大学Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3) 60 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07010133 は 介入研究 臨床試験 で、うつ病、身体不活動 に関するものです。現在は 募集準備中 で、2026年2月15日 に開始予定です。60 名の参加者 の募集が計画されています。この試験は サンディエゴ州立大学 によって主導され、2027年1月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月11日 です。
概要
This small randomized controlled trial will evaluate a workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity...もっと見る
詳細説明
Depression and physical inactivity are leading contributors to cardiometabolic diseases such as obesity, diabetes, and cardiovascular disease. Low-wage workers, who comprise one third of all workers in the U.S. and are essential to many industries, are more likely to be physically inactive and to have cardiometabolic conditions and depression, yet the participants are half as likely as higher wage workers to utilize ...もっと見る
公式タイトル
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).
疾患名
うつ病身体不活動その他の研究識別子
- IRB-24-0260
- K23HL157763 (米国NIHの助成金/契約)
NCT番号
開始日
2026-02-15
最終更新日
2026-02-11
終了予定日
2027-01-31
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Depression
Physical Activity
Employees
Worker Health
Low-income
Social needs
Physical Activity
Employees
Worker Health
Low-income
Social needs
主目的
治療
割付方法
無作為化
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Immediate Intervention The intervention consists of assessment of depression and work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. | A workplace-based depression intervention for low-wage hospital workers This intervention is a remotely delivered workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. |
実薬対照薬Waitlist Control Delivered after a 4-month waitlist period, the intervention consists of assessment of depression and work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. | A workplace-based depression intervention for low-wage hospital workers This intervention is a remotely delivered workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Intervention feasibility | Feasibility will be assessed by the number of intervention sessions completed. The intervention will be considered feasible if the majority of participants complete 75% (6 of 8) or more phone sessions. | From enrollment to end of treatment (approximately 4 months after enrollment). |
Depression symptoms | Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symptoms) | From baseline through end of treatment (approximately 4 months after enrollment). |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Work limitations | Work limitations (range: 0-100%, higher = more limitation) will be measured by the Work Limitations Questionnaire. | From baseline to end of treatment (approximately 4 months after enrollment) |
Perceived stress | Perceived stress measured by the Perceived Stress Scale (range 0-40, higher = more perceived stress). | From baseline to end of treatment (approximately 4 months after enrollment) |
Sleep quality | Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality). | Baseline, follow-up (4 months) |
Physical activity - step count | Weekly step count as measured by wrist-worn FitBit watch | Baseline, follow-up (4 months) |
Body Mass Index | A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared. | Baseline, follow-up (4 months) |
Blood pressure | Resting systolic and diastolic blood pressures | Baseline, Follow-up (4 months) |
Physical Activity (self-report) | Self-reported physical activity using the Global Physical Activity Questionnaire | Baseline, Follow-up (4 months) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- part-time or full-time employment (at least 20 hours per week);
- ≥18 years old;
- employed in low-wage-earning jobs in the Environmental Services or Food & Nutrition Services Departments;
- presence of depression symptoms as measured by the Patient Health Questionnaire-9 item version; individuals who score ≥5 (indicating mild depression symptoms or higher) will be eligible;
- presence of impairment in work functioning, as measured by the Work Limitations Questionnaire; individuals who score ≥5% (indicating mild work productivity loss) will be eligible;
- possession of a cell phone with ability to receive text-messages;
- Fluent in either English or Spanish.
- plan to leave Scripps employment in <6 months;
- severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
サンディエゴ州立大学アメリカ国立心肺血液研究所747 件のアクティブな治験を探索試験中央連絡先
連絡先: Jessica L McCurley, PhD, MPH, 619-594-2132, [email protected]
1 1カ国の場所
California
San Diego State University, San Diego, California, 92115, United States
Jessica L McCurley, PhD, MPH, 連絡先, 619-594-2132, [email protected]
Jessica L McCurley, PhD, MPH, 主任研究者