Well-Being, PsychologicalPERSISTNCT06139614
Personal Resilience Skills to Improve Surgery Training
A study testing PERSIST in people with Well-Being, Psychological and Anxiety Depression, run by Duke University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Well-Being, Psychological, Anxiety Depression
- What is being tested?
- PERSIST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pilot cohort will be composed of junior assistant residents (JAR) and senior assistant residents (SAR) members of the Duke General Surgery Residency Program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Well-Being, Psychological, Anxiety Depression
- Being tested
- PERSIST
- Keywords
- Personal resilience, Professional Fulfillment, Positive Well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERSISTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Assistant Residents | Experimental | 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. Receives: Behavioral: PERSIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Acceptability as measured by participant attendance in mean percent
Investigators will track participant attendance over the duration of the intervention and report in total mean percent.
Measured: Intervention end - 16 weeks
Program Acceptability as measured by Questionnaire
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).
Measured: Intervention end - 16 weeks
Professional Well-being as measured by the Professional Fulfillment Index (PFI)
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).
Measured: 3 months post-intervention
Personal Well-being as measured by the Self-Valuation (S-V) scale
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).
Measured: 3 months post-intervention
Positive well-being as assessed by the Flourishing Scale (FS)
Positive well-being will be assessed by the Flourishing Scale (FS), which is scored on a scale of 8-56 (higher score = better outcome).
Measured: 3 months post-intervention
Exhaustion as measured by the Professional Fulfillment Index (PFI)
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).
Measured: 3 months post-intervention
Anxiety symptoms as measured by the General Anxiety Disorder-7 questionnaire (GAD-7)
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).
Measured: 3 months post-intervention
Depression symptoms as measured by the 8-item version of the Patient Health Questionnaire (PHQ-8)
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).
Measured: 3 months post-intervention
Secondary outcomes (2)
Clinical and professional competencies measured by milestone achievement in Entrustable Professional Activities (EPA)
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.
Measured: 3 months post-intervention
Safety outcomes as measured by mean number of Safety Reporting System (SRS) incidents
Safety outcomes will be assessed by mean number of Safety Reporting System (SRS) incidents compared to non-participants.
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Aug 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Tracy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139614
- Sponsor's protocol ID
- Pro00113779
- Acronym
- PERSIST
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Resilience Skills to Improve Surgery Training (PERSIST)
- ClinicalTrials.gov ID
- NCT06139614
- Acronym / sponsor ID
- PERSIST / Pro00113779
- Conditions
- Well-Being, Psychological, Anxiety Depression
- Keywords
- Personal resilience, Professional Fulfillment, Positive Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Assistant Residents | Experimental | Behavioral: PERSISTAt 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The pilot cohort will be composed of junior assistant residents (JAR) and senior assistant residents (SAR) members of the Duke General Surgery Residency Program.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERSISTPERSIST 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. | Behavioural | Assistant Residents |
Primary outcome
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.
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).
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).
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).
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).
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).
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).
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).
2 secondary outcomes
Clinical and professional competencies measured by milestone achievement in Entrustable Professional Activities (EPA)
Time frame: 3 months post-intervention
Safety outcomes as measured by mean number of Safety Reporting System (SRS) incidents
Time frame: 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Tracy, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERSIST in people with Well-Being, Psychological and Anxiety Depression, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Acceptability as measured by participant attendance in mean percent (time frame: Intervention end - 16 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.