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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03759795
Other study ID # 1819/IRASSR/1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2018
Est. completion date January 1, 2022

Study information

Verified date March 2022
Source Bournemouth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Research in a range of occupational settings has indicated that resilience plays an important role in ameliorating the impact of adverse events in high pressure environments. This project will use a randomised controlled trial research design to assess the efficacy of brief one-to-one Acceptance and Commitment Training (ACTr), designed to enhance surgeons' psychological resilience. According to the model ACTr is based on, psychopathology is primarily the consequence of psychological inflexibility i.e. inability to persist or change behaviour according to long-term values due to language and cognition skills, which has particular significance when an individual is confronted with stress or adversity. The main aim of this research is to assess the efficacy of a brief one-to-one Acceptance and Commitment Training course. Researchers wish to ascertain whether such a course can increase surgeons' resilience by increasing psychological flexibility, valuing and self-compassion (all of which are expected to be positively impacted by this training). This research will fill a gap in the relevant research literature; namely that no research project as far as we are aware has evaluated ACTr as a means to enhance resilience in surgeons. In fact any research conducted on resilience training with a surgical population is rare.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: Trainee surgeons and consultant surgeons Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Bournemouth
United Kingdom Poole Hopsital Poole

Sponsors (2)

Lead Sponsor Collaborator
Bournemouth University Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Resilience - Brief Resilience Scale (BRS) A self-report measure of psychological resilience. Higher values represent a better outcome. 20 weeks
Primary General Health - General Health Questionnaire (GHQ-12). A self reported measure of minor psychological symptomology in a non-clinical population. 20 weeks
Secondary CBI (Copenhagen Burnout Inventory) A self-report measure of vulnerability to burnout. Lower values represent a better outcome. 20 weeks
Secondary DASS21 (Depression Anxiety and Stress Scale) A self-report measure of depression, stress and anxiety. Lower values represent a better outcome. 20 weeks
Secondary VLQ (Value Living Questionnaire) A self-report measure of valuing. Higher values represent a better outcome. 20 weeks
Secondary WAAQ (Work related Acceptance and Action Questionnaire) A self-report measure of work related psychological flexibility. Higher values represent a better outcome. 20 weeks
Secondary AAQII (Acceptance and Action Questionnaire) A self-report measure of general psychological inflexibility. Lower values represent a better outcome. 20 weeks
Secondary SCS (Self Compassion Scale) A self-report measure of self compassion. Higher values represent a better outcome. 20 weeks
Secondary SPS (Sense of Preparedness Scale) A self-report measure of preparedness for potential future events. Higher values represent a better outcome. 20 weeks