Meditation, Mindfulness, and Yoga to Reduce Perceived Stress in Resident Doctors - A Randomized Controlled Trial With Crossover Design (MindYou)

Does a 6-week Specially Designed Meditation, Mindfulness, and Yoga Program Reduce Perceived Stress in Resident General Practitioners? - A Randomized Controlled Trial With Crossover Design.

General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. The aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress, Job
• Intervention / Treatment: Behavioral: MindYou

Detailed Description

The study is designed as a randomized controlled trial with a crossover design. The outcome measure is the level of stress assessed using the Perceived Stress Scale (PPS), Swedish version (PSS 14). Inclusion criteria are resident general practitioners in Skåne, within the preliminary catchment area of Malmö Trelleborg, who have experienced any form of stress symptoms they believe are related to their work. Participants will be recruited through an oral presentation during an educational seminar in spring 2024. Those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. Participants will be randomised to intervention (I) or waiting list (C). The interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). The sessions will be sent to the participant on USB-stick or via webb-link. Each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. The preliminary themes that will be addressed are 'Handling Mistakes,' 'Letting Go of Work,' 'Setting Boundaries,' 'Taking Breaks,' 'Being Good Enough,' and 'Managing Work Stress. The participants are encouraged to perform the program at least 3 times/week. Both groups will fill in the PSS-questionnaire at study start and after 6 weeks.

The control group will start the intervention after the second questionnaire (week 7-12) and will fill out the PSS-questionnaire a third time after intervention completion. The results will be analysed according to intention to treat. The Mann-Whitney U-test will be used to compare whether there is a significant difference in the change of median values on PSS 14 between the intervention and control groups.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moa Wolff; Phone Number: +4670284424; Email: moa.wolff@med.lu.se
• Study Contact Backup: Name: Josefine Terdén; Phone Number: +4670284424; Email: josefineterden@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Resident doctor in primary care having felt work related stress at any time

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Experimental: Intervention A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work. Each session lasts for about 20 minutes and the participant is encouraged to perform the session at least 3 times/week.	Behavioral: MindYou; A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work.
Active Comparator: Waiting list; The first 6 weeks of the study, the participants will be controls. During week 6-12 they will then perform the intervention according to the description above.	Behavioral: MindYou; A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSS14	Self perceived stress According till PSS 14	12 weeks

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Study Director: Moa Wolff, Lund University

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; meditation; yoga
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: Dnr 2023-05678-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No