A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals (ICOP)

A Randomized Controlled Evaluation of a Compassion-course With the Aim of Reducing Stress of Conscience and Work-related Stress and Increase Levels of Professional Quality of Life and Self-compassion in Healthcare Professionals

The aim is to investigate whether an internet-based compassion course of five modules contributes to reducing stress of conscience and work-related stress, increase the experience of professional quality of life and self-compassion in healthcare professionals.

Study Overview

• Status: Recruiting
• Conditions: Compassion; Psychological Stress; Occupational Health; Cognitive Behavioral Therapy
• Intervention / Treatment: Behavioral: Internet-based compassion course for stress managemant; Behavioral: General Internet-based cognitive behavioural course for stress management

Detailed Description

Reactions to severe stress is one of the most common causes of sick leave in Sweden. Previous research has shown that compassion interventions for staff can affect work-related stress by increased self-care, better self-awareness and an increased healthy attitude, however, Swedish studies on the subject are scarce.

Compassion is a motivation to reduce suffering in oneself and others characterized by a warm, understanding, and respectful attitude. In addition to beneficial effects for the staff, a compassion-oriented approach, has shown to improve the relationship between patient and staff, increase patient satisfaction with care and reduce patient anxiety and stress. As a result of the covid-19 pandemic, healthcare professionals have been exposed to difficult physical and mental work conditions that cause feelings of stress and inadequacy. In the long run, increased stress can cause fatigue and increased number of sick leaves. This can in turn contribute to increased stress for the staff who remain working and difficulties to recruit new staff, which make the situation worse. There is a lack of interventions for staff aimed at preventing stress-related health issues, enabling recovery and reduce mental suffering linked to a stressful work situations. The aim of this study is to find a method that help healthcare providers cope with stress of conscience in relation to stressful work situations, particularly during the current covid-19 pandemic. A five week internet-based compassion course of five modules will be conducted and evaluated with the aim of exploring whether the course contributes to reduce stress of conscience and work-related stress, and increases the levels of professional quality of life and self-compassion among healthcare professionals. The internet-based compassion course will be compared with: one group that is on a waiting list for ten weeks and then receives an internet-based general stress management course and one group that participate in the general stress management course.

• Study Type: Interventional
• Enrollment (Estimated): 548
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna S Bratt, PhD; Phone Number: +46706015998; Email: anna.bratt@lnu.se
• Study Contact Backup: Name: Maude Johansson, Phd; Phone Number: +46725941677; Email: maude.johansson@lnu.se

Study Locations

• Sweden
  • Kronoberg
    • Växjö, Kronoberg, Sweden, 35195
      • Recruiting
      • Linnaeus University, Department of Psychology
      • Contact: Anna Bratt, PhD; Phone Number: +46706015998; Email: anna.bratt@lnu.se
      • Contact: Viktor Kaldo, Professor; Email: viktor.kaldo@lnu.se
      • Sub-Investigator: Maude Johansson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The inclusion criteria will be as follows: the participants work directly with patients full-time or part-time, score 45 points or higher on the primary outcome measure Stress of Conscience Questionnaire (SCQ), are proficient in Swedish, have the requisite time to attend a digital course, and accept the course's format.

The exclusion criteria include being partially or fully on sick leave due to stress.

All criteria are assessed on the basis of self-assessment forms of the participants, but in case of uncertainty, follow-up questions can be done by phone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based compassion course; Therapist guided Internet-compassion course for workrelated stress.	Behavioral: Internet-based compassion course for stress managemant; A five week long, structured self-help program with weekly reports to, and feedback from a compassion-focused (CFT) therapist over the Internet. Includes traditional CFT-methods for stress-related problems.
Active Comparator: General internet-based CBT stress management course; Therapist guided Internet-cognitive behavioral (CBT) course for workrelated stress.	Behavioral: General Internet-based cognitive behavioural course for stress management; A five week long, structured self-help program with weekly reports to, and feedback from a cognitive-behavioral (CBT) therapist over the Internet. Includes traditional CBT-methods for stress-related problems.
Other: Waitlist; Waitlist for 10 weeks, and thereafter the general internet-based CBT management course.	Behavioral: General Internet-based cognitive behavioural course for stress management; A five week long, structured self-help program with weekly reports to, and feedback from a cognitive-behavioral (CBT) therapist over the Internet. Includes traditional CBT-methods for stress-related problems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (from baseline) in Stress of conscience	Stress of Conscience Questionnaire (SCQ). The purpose of the SCQ is to estimate stress related to a troubled conscience. The questionnaire consists of nine items describing different healthcare situations, each made up of two parts, an A question and a B question. The A question concerns how frequently the subject estimates that the situation discussed arises in the workplace. This is assessed on a 6-point Likert scale, where 0 is 'Never' and 5 stands for 'Every day'. For each A question, there is a B question following it, in which the degree to which the conscience is troubled in the given situation is estimated on a 10 cm visual analogue scale. The visual analogue scale ranges from 0 = 'No, it gives me no troubled conscience at all' to 5 = 'Yes, it gives me a very troubled conscience'.	0, 5, 10 and 15 weeks and 6 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (from baseline) in Professional quality of life	Professional quality of life scale (PROQOL) Professional quality of life is the quality one feels in relation to their work as a helper. Both the positive and negative aspects of doing one's job influence ones professional quality of life. Professional quality of life incorporates two aspects, the positive (Compassion Satisfaction) and the negative (Compassion Fatigue). Compassion fatigue breaks into two parts. The first part concerns things such like exhaustion, frustration, anger and depression typical of burnout. Secondary Traumatic Stress is a negative feeling driven by fear and work-related trauma. Some trauma at work can be direct (primary) trauma. In other cases, work-related trauma be a combination of both primary and secondary trauma. The PROQOL consists of 30 questions assessed on a 5-point Likert scale, where 0 is 'Never' and 5 stands for 'Very often'.	0, 5, 10 and 15 weeks and 6 months after baseline
Change (from baseline) in Work-related stress	Copenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.	0, 5, 10 and 15 weeks and 6 months after baseline
Change (from baseline) in Self-compassion	Self-compassion scale (SCS) consists of 26 items, assessed on a 5-point Likert scale, where 0 is 'Almost never' to 5 for 'Almost always'.	0, 5, 10 and 15 weeks and 6 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave	Sick leave from MIDAS registry, from the Swedish Social Insurance Agency	Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.
Satisfaction with treatment	Questions of satisfaction with the internet-based course and treatment credibility scale.	Week 5 after baseline

Collaborators and Investigators

• Sponsor: Linnaeus University
• Collaborators: Vastra Gotaland Region; Kronoberg County Council; Sormland County Council, Sweden; Kalmar County Council
• Investigators: Principal Investigator: Anna S Bratt, PhD, Linnaeus University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 2020-05505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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