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O estudo clínico NCT07010133 para Depressão, Inatividade física está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
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O estudo clínico NCT07010133 é um ensaio intervencionista para Depressão, Inatividade física. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de novembro de 2025, com o objetivo de incluir 60 participantes. Coordenado por a Universidade Estadual de San Diego e deve ser concluído em 31 de janeiro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 22 de junho de 2025.
Resumo
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.
Descrição detalhada
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 preventive care. Targeted workplace initiatives have been successful in improving employee health, but low-wage workers are difficult to engage, in part due to a high burden of social disadvantage (e.g., food and housing insecurity, time and financial constraints). There are few, if any, workplace interventions for depression that specifically target low-wage workers and the participants unique social risk factors. This study was designed using a planned adaptation approach that involved low-wage workers in the design of the intervention to increase engagement and feasibility. The study will test an evidence-based 8-session telephone-delivered depression intervention for working adults, Be Well at Work, and critical adaptations for low-wage workers: assessment and referrals for social determinants of health (e.g., food and housing insecurity, financial stress), physical activity promotion, and personalized text message behavioral support. The adapted intervention, Be Well at Work-PLUS, will be evaluated through a pilot randomized controlled trial comparing Be Well at Work-PLUS to a waitlist condition. The primary objectives are to assess acceptability, feasibility, and preliminary clinical outcomes. The primary preliminary clinical outcome is depression symptom severity, and secondary outcomes are physical activity, sleep quality, blood pressure, and BMI).
Título oficial
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).
Condições
DepressãoInatividade físicaOutros IDs do estudo
- IRB-24-0260
- K23HL157763 (Subvenção/Contrato NIH (EUA))
Número NCT
Data de início (real)
2025-11-01
Última atualização postada
2025-06-22
Data de conclusão (estimada)
2027-01-31
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Depression
Physical Activity
Employees
Worker Health
Low-income
Social needs
Physical Activity
Employees
Worker Health
Low-income
Social needs
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalImmediate 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. |
Comparador ativoWaitlist 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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). |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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)
Contato central do estudo
Contato: Jessica L McCurley, PhD, MPH, 619-594-2132, [email protected]
1 Locais do estudo em 1 países
California
San Diego State University, San Diego, California, 92115, United States
Jessica L McCurley, PhD, MPH, Contato, 619-594-2132, [email protected]
Jessica L McCurley, PhD, MPH, Investigador principal