NCT06970340

Brief Summary

This study is testing a web-based "Intern Boot Camp" from Online MedEd to see if it can make the first year of residency less stressful for new internal-medicine doctors at Harlem Hospital. Right after orientation, residents are randomly placed into one of two groups: Intervention group - gets six months of free access to the Bootcamp videos plus twice-a-week, one-hour review sessions led by senior residents the first 6 months of residency Control group - gets the hospital's usual training and will receive the Bootcamp training starting at 6-month of residency. The main thing the researchers want to know is: Does using the Boot Camp lower burnout-especially emotional exhaustion-compared with usual training? They will also look at the PHQ-9 depression survey and how confident residents feel about four everyday skills: mental health self-care, time management, oral presentation, and medical documentation. Surveys are completed at the start of residency and again six months later. Findings will show whether giving residents structured, on-demand preparation improves their well-being and confidence during the toughest part of their training.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 6, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

InternsBootcampBurnoutWellnessFirst Year Resident

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Burnout at 3 months and 6 months

    The Maslach's burnout inventory is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores of EE ≥ 27 points, DP ≥ 10, and PF \<33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.

    Baseline measurement, post-intervention measurements at 3 months and 6 months

Secondary Outcomes (1)

  • Proportion of participants whose PHQ-9 total score is ≥ 10 at 3 months and 6 months

    Baseline measurement, post-intervention measurements at 3 months and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Enrolled into a 6-month online training program plus biweekly live discussion sessions from July 15 2024 to January 15 2025

Behavioral: Online MedEd Intern Bootcamp

Control

NO INTERVENTION

Residency training as usual. No access to online training platform or live sessions.

Interventions

6 months of online access plus biweekly live sessions

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Incoming first year of residency

You may not qualify if:

  • Previous United States Accredited Postgraduate Training
  • PHQ-9 score above 20
  • PHQ-9 positive for suicidality (question 9)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harlem Hospital Center

Manhattan, New York, 10037, United States

Location

Related Publications (1)

  • Guille C, Zhao Z, Krystal J, Nichols B, Brady K, Sen S. Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1192-8. doi: 10.1001/jamapsychiatry.2015.1880.

    PMID: 26535958BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Raji Ayinla, M.D., CMD, FCCP, FACP

    New York City Health and Hospitals Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover timeline: First group July 15 2024 - January 05 2025 Second group January 06 2025 - June 15 2025
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medicine

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

July 2, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the primary and secondary outcome results (baseline demographic variables, intervention allocation, PHQ-9, MBI, Mini-ReZ scores at baseline, 3 months and 6 months plus the data dictionary and statistical analysis code will be shared. Direct identifiers (name, email, MRN, full dates of birth) and high-risk elements (audio/video files, free-text survey comments) will not be shared to protect confidentiality in this small cohort.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available beginning 12 months after publication of the main results and for 5 years via the controlled-access repository Vivli
Access Criteria
Researchers with a methodologically sound proposal, IRB/ethics approval, and a signed data-use agreement may request access through the Vivli platform's review committee.

Locations