NCT07010133

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
8mo left

Started Jun 2026

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

May 30, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

DepressionPhysical ActivityEmployeesWorker HealthLow-incomeSocial needs

Outcome Measures

Primary Outcomes (2)

  • 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).

Secondary Outcomes (7)

  • Work limitations

    From baseline to end of treatment (approximately 4 months after enrollment)

  • Perceived stress

    From baseline to end of treatment (approximately 4 months after enrollment)

  • Sleep quality

    Baseline, follow-up (4 months)

  • Physical activity - step count

    Baseline, follow-up (4 months)

  • Body Mass Index

    Baseline, follow-up (4 months)

  • +2 more secondary outcomes

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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.

Behavioral: A workplace-based depression intervention for low-wage hospital workers

Waitlist Control

ACTIVE COMPARATOR

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.

Behavioral: A workplace-based depression intervention for low-wage hospital workers

Interventions

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.

Immediate InterventionWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • plan to leave Scripps employment in \<6 months;
  • severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92115, United States

Location

MeSH Terms

Conditions

DepressionSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jessica L McCurley, PhD MPH

    San Diego State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica L McCurley, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a pilot randomized controlled trial with a waitlist control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Currently we do not plan to share data as this is an open pilot study with a small number of participants (N=60), and thus it could be possible identify individuals.

Locations