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NCT Number: NCT04700878

A Randomized Controlled Evaluation of a Compassion-course for 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linnaeus University, Department of Psychology

Vaxjo, Kronoberg County, 35195, Sweden

Location status: Recruiting

Location contact

Anna Bratt, PhD

CONTACT

[email protected]

+46706015998

Maude Johansson, PhD

SUB_INVESTIGATOR

Viktor Kaldo, Professor

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-based compassion course for stress managemant

Behavioral

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.

General Internet-based cognitive behavioural course for stress management

Behavioral

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.

Primary outcomes

  1. Change (from baseline) in Stress of conscience

    Time frame: 0, 5, 10 and 15 weeks and 6 months after baseline

    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'.

Secondary outcomes

  1. Change (from baseline) in Professional quality of life

    Time frame: 0, 5, 10 and 15 weeks and 6 months after baseline

    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'.

  2. Change (from baseline) in Work-related stress

    Time frame: 0, 5, 10 and 15 weeks and 6 months after baseline

    Copenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.

  3. Change (from baseline) in Self-compassion

    Time frame: 0, 5, 10 and 15 weeks and 6 months after baseline

    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'.

Other outcomes

  1. Sick leave

    Time frame: Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.

    Sick leave from MIDAS registry, from the Swedish Social Insurance Agency

  2. Satisfaction with treatment

    Time frame: Week 5 after baseline

    Questions of satisfaction with the internet-based course and treatment credibility scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna S Bratt, PhD

CONTACT

[email protected]

+46706015998

Maude Johansson, Phd

CONTACT

[email protected]

+46725941677

Sponsors and collaborators

Lead sponsor

Linnaeus University

Other

Collaborators

  • Kronoberg County Council
  • Region Kalmar County
  • Sormland County Council, Sweden
  • Vastra Gotaland Region

Registry information

Official study title

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

Acronym: ICOP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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