- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139614
Personal Resilience Skills to Improve Surgery Training (PERSIST)
Personal Resilience Skills to Improve Surgery Training (PERSIST)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Elisabeth Tracy, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
International Association Psychosomatics And Health...RecruitingAnxiety | Anxiety DepressionUkraine
-
Duke Kunshan UniversityNational Natural Science Foundation of China; Kunshan Hospital of Traditional... and other collaboratorsNot yet recruitingAnxiety DepressionChina
-
University of PatrasUniversity of Bologna; Modena Health Authority; 6th Hellenic Health DistrictNot yet recruitingAnxiety DepressionGreece, Italy
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Recruiting
-
University of California, BerkeleyUniversity of California, San Francisco; University of California, IrvineRecruiting
-
Moon (Guangzhou) Biotechnology Co., Ltd.Not yet recruiting
-
Florida State UniversityNational Cancer Institute (NCI)Recruiting
-
University of AlcalaCompletedAnxiety | Depressive Symptoms | Anxiety Symptoms | Subthreshold DepressionSpain
-
University Rovira i VirgiliUniversitat de Girona; University Ramon LlullActive, not recruiting
Clinical Trials on PERSIST
-
Johns Hopkins UniversityNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States