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

Primary Purpose

Psychological Stress, Compassion, Occupational Health

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based compassion course for stress managemant
General Internet-based cognitive behavioural course for stress management
Sponsored by
Linnaeus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Stress

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Linnaeus University, Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Internet-based compassion course

General internet-based CBT stress management course

Waitlist

Arm Description

Therapist guided Internet-compassion course for workrelated stress.

Therapist guided Internet-cognitive behavioral (CBT) course for workrelated stress.

Waitlist for 10 weeks, and thereafter the general internet-based CBT management course.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.
Change (from baseline) in Work-related stress
Copenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.
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'.

Full Information

First Posted
January 4, 2021
Last Updated
October 3, 2023
Sponsor
Linnaeus University
Collaborators
Vastra Gotaland Region, Kalmar County Council, Sormland County Council, Sweden, Kronoberg County Council
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1. Study Identification

Unique Protocol Identification Number
NCT04700878
Brief Title
A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals
Acronym
ICOP
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linnaeus University
Collaborators
Vastra Gotaland Region, Kalmar County Council, Sormland County Council, Sweden, Kronoberg County Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Compassion, Occupational Health, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sample size was determined based on an expected between group effect size (between ICOP and ICB) of Cohen's d = 0.4 for the primary outcome at the five-week follow-up for the primary analysis for participants with SCQ scores of 45 and higher. To reach 80% power, the study need 100 participants in each active arm. Expecting 20% attrition, the investigators will include 120 participants. Thirty participants are required in the waitlist group with an expected between-group effect between the ICOP group and the waitlist of d = 0.8. Including the expected attrition, 36 participants will be required. Given the 200 participants and a power of 80%, the non-inferiority analysis will provide a minimal clinically important difference of roughly d = 0.35. Participants with SCQ scores below 45 will be included for secondary analyses, thus expect to include 480 participants (ICOP and ICB), with an additional 72 participants in the waitlist group, for a total of 552.
Masking
Care Provider
Masking Description
This study is a single-blind randomized trial where eligible participants will informed about that they will be assigned to either of two different stress-management courses or to waitlist, but they are unaware of which particular conditions. The waitlist group (ten weeks waitlist and thereafter either compassion- or cognitive behavioural courses) will receive thorough information about the two different courses and thereafter rate how attractive they find each course. Then they get to choose which course they want to attend to.
Allocation
Randomized
Enrollment
548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based compassion course
Arm Type
Experimental
Arm Description
Therapist guided Internet-compassion course for workrelated stress.
Arm Title
General internet-based CBT stress management course
Arm Type
Active Comparator
Arm Description
Therapist guided Internet-cognitive behavioral (CBT) course for workrelated stress.
Arm Title
Waitlist
Arm Type
Other
Arm Description
Waitlist for 10 weeks, and thereafter the general internet-based CBT management course.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based compassion course for stress managemant
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Internet-based cognitive behavioural course for stress management
Intervention Description
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 Outcome Measure Information:
Title
Change (from baseline) in Stress of conscience
Description
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'.
Time Frame
0, 5, 10 and 15 weeks and 6 months after baseline
Secondary Outcome Measure Information:
Title
Change (from baseline) in Professional quality of life
Description
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'.
Time Frame
0, 5, 10 and 15 weeks and 6 months after baseline
Title
Change (from baseline) in Work-related stress
Description
Copenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.
Time Frame
0, 5, 10 and 15 weeks and 6 months after baseline
Title
Change (from baseline) in Self-compassion
Description
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'.
Time Frame
0, 5, 10 and 15 weeks and 6 months after baseline
Other Pre-specified Outcome Measures:
Title
Sick leave
Description
Sick leave from MIDAS registry, from the Swedish Social Insurance Agency
Time Frame
Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.
Title
Satisfaction with treatment
Description
Questions of satisfaction with the internet-based course and treatment credibility scale.
Time Frame
Week 5 after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna S Bratt, PhD
Phone
+46706015998
Email
anna.bratt@lnu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maude Johansson, Phd
Phone
+46725941677
Email
maude.johansson@lnu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna S Bratt, PhD
Organizational Affiliation
Linnaeus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linnaeus University, Department of Psychology
City
Växjö
State/Province
Kronoberg
ZIP/Postal Code
35195
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Bratt, PhD
Phone
+46706015998
Email
anna.bratt@lnu.se
First Name & Middle Initial & Last Name & Degree
Viktor Kaldo, Professor
Email
viktor.kaldo@lnu.se
First Name & Middle Initial & Last Name & Degree
Maude Johansson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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