NCT03759795

Brief Summary

The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 14, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

November 13, 2018

Last Update Submit

March 1, 2022

Conditions

Keywords

ResiliencePsychological flexibilityAcceptance and Commitment Training

Outcome Measures

Primary Outcomes (2)

  • Resilience - Brief Resilience Scale (BRS)

    A self-report measure of psychological resilience. Higher values represent a better outcome.

    20 weeks

  • General Health - General Health Questionnaire (GHQ-12).

    A self reported measure of minor psychological symptomology in a non-clinical population.

    20 weeks

Secondary Outcomes (7)

  • CBI (Copenhagen Burnout Inventory)

    20 weeks

  • DASS21 (Depression Anxiety and Stress Scale)

    20 weeks

  • VLQ (Value Living Questionnaire)

    20 weeks

  • WAAQ (Work related Acceptance and Action Questionnaire)

    20 weeks

  • AAQII (Acceptance and Action Questionnaire)

    20 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Acceptance and Commitment Training (ACTr)

Behavioral: ACTr (Acceptance and Commitment Training)

Wait-list control

NO INTERVENTION

No intervention during trial. Participants in this group will be offered the training once the study is complete.

Interventions

The programme is based on Acceptance and Commitment Training (ACT), a contemporary, empirically supported approach to psychological well-being.

Intervention Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trainee surgeons and consultant surgeons

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

Poole Hopsital

Poole, BH15 2JB, United Kingdom

Location

Related Publications (9)

  • Finnes A, Ghaderi A, Dahl J, Nager A, Enebrink P. Randomized controlled trial of acceptance and commitment therapy and a workplace intervention for sickness absence due to mental disorders. J Occup Health Psychol. 2019 Feb;24(1):198-212. doi: 10.1037/ocp0000097. Epub 2017 Sep 28.

    PMID: 28956942BACKGROUND
  • Flaxman PE, Bond FW. A randomised worksite comparison of acceptance and commitment therapy and stress inoculation training. Behav Res Ther. 2010 Aug;48(8):816-20. doi: 10.1016/j.brat.2010.05.004. Epub 2010 May 8.

    PMID: 20627269BACKGROUND
  • Pinto A, Faiz O, Davis R, Almoudaris A, Vincent C. Surgical complications and their impact on patients' psychosocial well-being: a systematic review and meta-analysis. BMJ Open. 2016 Feb 16;6(2):e007224. doi: 10.1136/bmjopen-2014-007224.

    PMID: 26883234BACKGROUND
  • Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.

    PMID: 19934755BACKGROUND
  • Balch CM, Shanafelt TD, Dyrbye L, Sloan JA, Russell TR, Bechamps GJ, Freischlag JA. Surgeon distress as calibrated by hours worked and nights on call. J Am Coll Surg. 2010 Nov;211(5):609-19. doi: 10.1016/j.jamcollsurg.2010.06.393. Epub 2010 Sep 20.

    PMID: 20851643BACKGROUND
  • Flaxman P. , Bond, F., Livheim, F. (2013): The Mindful and Effective Employee: An Acceptance and Commitment Therapy Training Manual for Improving Well-Being and Performance. New Harbinger Publications; 2013

    BACKGROUND
  • Turner, K., Johnson, C., Thomas, K., Bolderston, H., & McDougall, S. (2016). The impact of complications and errors on surgeons. The Bulletin Of The Royal College Of Surgeons Of England, 98(9), 404-407. doi: 10.1308/rcsbull.2016.404

    BACKGROUND
  • Greville-Harris M, Wezyk A, Thomas K, Richer S, Bolderston H, Purchase N, McDougall S, Turner KJ. Acceptance and commitment therapy- based intervention to improve psychological skills and resilience in surgical trainees: a randomised waitlist-controlled trial. BMC Surg. 2025 Jul 28;25(1):315. doi: 10.1186/s12893-025-03059-5.

  • Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

Study Officials

  • Helen Bolderston

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomised Controlled Trial. Wait-list control for half participants. Other half receive ACTr (acceptance and commitment training) intention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 30, 2018

Study Start

February 14, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations