Personal Resilience Skills to Improve Surgery Training (PERSIST)

April 26, 2024 updated by: Duke University

Personal Resilience Skills to Improve Surgery Training (PERSIST)

The objective of the current study (PERSIST) is to 1) determine acceptability of an 8-session (16 week) group curriculum on personal resilience skills for residents in the Duke General Surgery Program, and 2) examine changes in professional fulfillment, depression symptomatology, anxiety symptomatology, and self-valuation, and positive wellbeing (flourishing) at the end of the program and 3-month follow-up compared to baseline, 3) examine performance on surgery training metrics compared to the mean performance of non-participants. Participants will be residents active in the Duke General Surgery Program. There will be one group of Junior Assistant Residents (JAR, N = 10) and one group of Senior Assistant Residents (SAR, N =10), which will be conducted separately. At baseline, all participants will complete questionnaires related personal resilience, including professional fulfillment (professional fulfillment, work exhaustion, interpersonal disengagement), depression symptoms, anxiety, symptoms, self-valuation, flourishing, and psychosocial working conditions. At post-treatment (end of session 8), participants will complete the baseline questionnaires (with the exception of psychosocial working conditions), as well as a questionnaire assessing acceptability of the group experience and content. The post-treatment questionnaires will be repeated as a 3-month follow-up. All study activities are considered low risk, and there the training is expected to have the benefit of teaching lasting skills to promote professional and personal resilience. To protect participant confidentiality, surgery staff and faculty will not have access linkage between study variables and participant identity.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The primary aims/objectives are to examine acceptability of the PERSIST intervention, and pre-post changes relevant to resident resilience, as operationalized in measures of personal and professional well-being. The investigators intend to enroll both Junior Assistant Residents (JAR) and Senior Assistant Residents (SAR) cohorts in a combined sample; and secondarily results by group.

The secondary objective is to examine whether participation in PERSIST is associated with better training and safety outcomes compared to resident who do not participate.

Aim 1: Determine acceptability of an 8-session PERSIST intervention for General Surgery residents.

Aim 2: Assess change on measures of personal and professional well-being following an 8 session PERSIST intervention for General Surgery residents. The investigators anticipate that individuals completing PERSIST will show improvement in professional fulfillment, depression symptoms, anxiety symptoms, flourishing, and self-valuation at post-treatment and 3-month follow up compared to baseline.

Aim 3: Compare training and safety outcomes of PERSIST participants compared to non-participants.

PERSIST is adapted from empirically validated treatment of negative affect and low positive emotion. Skills Training 1 includes content across 4 sessions on 1) understanding emotions, 2) present-moment emotional awareness, 3) cognitive flexibility, and 4) countering avoidant and emotion-driven responses. Skills Training 2 includes content across 4 sessions on a) translating values to action, b) lower barriers to action, c) countering avoidance, and d) maintaining actions that support personal resilience. The classes will occur every other Wednesday, resulting in a 16-week intervention period.

The investigators plan to collect multiple sources of information on acceptability. Primarily this will be via questionnaire rating of the experience and value of the 8 content topics in PERSIST. Additionally, the investigators will review and categorize response from open ended content, track participant attendance over the duration of the intervention, and document any feasibility issues related to recruitment, attendance, or dissemination of content. All measures related to well-being assessed at pre-intervention, post-intervention, and 3-month follow up.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The pilot cohort will be composed of junior assistant residents (JAR) and senior assistant residents (SAR) members of the Duke General Surgery Residency Program.

Exclusion Criteria:

  • Because the PERSIST intervention is focused on coaching resilience to the challenges of clinical training, JAR and SAR who will be completing a research year during the intervention period will be excluded from participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assistant Residents
At baseline, all participants will complete questionnaires related personal resilience, including professional fulfillment (professional fulfillment, work exhaustion, interpersonal disengagement), depression symptoms, anxiety, symptoms, self-valuation, flourishing, and psychosocial working conditions. At post-treatment (end of session 8), participants will complete the baseline questionnaires (with the exception of psychosocial working conditions), as well as a questionnaire assessing acceptability of the group experience and content. The post-treatment questionnaires will be repeated as a 3-month follow-up.
PERSIST is adapted from empirically validated treatment of negative affect and low positive emotion. Skills Training 1 includes content across 4 sessions on 1) understanding emotions, 2) present-moment emotional awareness, 3) cognitive flexibility, and 4) countering avoidant and emotion-driven responses. Skills Training 2 includes content across 4 sessions on a) translating values to action, b) lower barriers to action, c) countering avoidance, and d) maintaining actions that support personal resilience. The classes will occur every other Wednesday, resulting in a 16-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Acceptability as measured by Questionnaire
Time Frame: Intervention end - 16 weeks
A questionnaire rating of the experience and value of the 8 content topics in PERSIST using a scale of 5-50 (higher score = higher acceptability).
Intervention end - 16 weeks
Professional Well-being as measured by the Professional Fulfillment Index (PFI)
Time Frame: 3 months post-intervention
Overall professional well-being will be assessed with the Professional Fulfillment Index (PFI), which is scored on a scale of 0-24 (higher score = better outcome).
3 months post-intervention
Personal Well-being as measured by the Self-Valuation (S-V) scale
Time Frame: 3 months post-intervention
Personal well-being will be assessed with the Self-Valuation scale (S-V), which is scored on a scale of 0-16 (higher score = better outcome).
3 months post-intervention
Positive well-being as assessed by the Flourishing Scale (FS)
Time Frame: 3 months post-intervention
Positive well-being will be assessed by the Flourishing Scale (FS), which is scored on a scale of 8-56 (higher score = better outcome).
3 months post-intervention
Exhaustion as measured by the Professional Fulfillment Index (PFI)
Time Frame: 3 months post-intervention
Exhaustion from work will be assessed with the Professional Fulfillment Index (PFI), which is scored on a scale of 0-44 (higher score = worse outcome).
3 months post-intervention
Anxiety symptoms as measured by the General Anxiety Disorder-7 questionnaire (GAD-7)
Time Frame: 3 months post-intervention
Anxiety symptoms will be assessed using the General Anxiety Disorder-7 questionnaire (GAD-7), which is scored on a scale from 0-21 (higher = worse outcome).
3 months post-intervention
Depression symptoms as measured by the 8-item version of the Patient Health Questionnaire (PHQ-8)
Time Frame: 3 months post-intervention
Depression symptoms will be assessed using the 8-item version of the Patient Health Questionnaire (PHQ-8), which is scored on a scale from 0-24 (higher = worse outcome).
3 months post-intervention
Program Acceptability as measured by participant attendance in mean percent
Time Frame: Intervention end - 16 weeks
Investigators will track participant attendance over the duration of the intervention and report in total mean percent.
Intervention end - 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and professional competencies measured by milestone achievement in Entrustable Professional Activities (EPA)
Time Frame: 3 months post-intervention

Clinical and professional competencies will be assessed by milestone achievement in Entrustable Professional Activities (EPA). EPA scores are core metrics for evaluating resident performance and providing feedback within the General Surgery Program.

Surgery training outcomes occur in the normal course of training and are not expressly collected as part of the PERSIST intervention. ABSITE and EPA scores are core metrics for evaluating resident performance and providing feedback within the General Surgery Program.

3 months post-intervention
Safety outcomes as measured by mean number of Safety Reporting System (SRS) incidents
Time Frame: 3 months post-intervention
Safety outcomes will be assessed by mean number of Safety Reporting System (SRS) incidents compared to non-participants.
3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Elisabeth Tracy, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113779

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety Depression

Clinical Trials on PERSIST

Subscribe