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

Sponsor
Linnaeus University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04700878
Collaborator
Vastra Gotaland Region (Other), Kalmar County Council (Other), Sormland County Council, Sweden (Other), Kronoberg County Council (Other)
548
1
3
52.9
10.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-based compassion course for stress managemant
  • Behavioral: General Internet-based cognitive behavioural course for stress management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
548 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change (from baseline) in Stress of conscience [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 Outcome Measures

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

  1. Sick leave [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 [Week 5 after baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Linnaeus University, Department of Psychology Växjö Kronoberg Sweden 35195

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Anna S Bratt, PhD, Linnaeus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Bratt, PhD, Linnaeus University
ClinicalTrials.gov Identifier:
NCT04700878
Other Study ID Numbers:
  • 2020-05505
First Posted:
Jan 8, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021