A 3-day Course for CFS/ME

A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial

Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem.

In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures.

There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed.

If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.

Study Overview

• Status: Recruiting
• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Intervention / Treatment: Behavioral: A 3-day course; Behavioral: Waiting list

Detailed Description

This is a randomized controlled trial (RCT) to investigate potential effects (positive and negative) of a 3-day course with follow-up for 100 adults with CFS/ME.

The 3-day course used in this trial is named the Lightning Process (LP). The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

Positive and negative effects of the course on symptoms, disability and quality of life will be investigated, and a long-term follow-up of work participation conducted.

Any adverse events experienced during or after the 3-day course will be handled according to protocol.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leif Edward Ottesen Kennair, PhD prof; Phone Number: +47 90557004; Email: kennair@ntnu.no
• Study Contact Backup: Name: Live Landmark; Phone Number: +47 91855303; Email: Livelan@stud.ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • Department of Psychology, NTNU
    • Contact: Leif Edward Ottesen Kennair, PhD prof; Email: kennair@ntnu.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CFS/ME diagnosis based on the Canada Consensus Criteria.
• At least 50% out of school/work.
• Readiness to change (corresponding to the preparation phase in transtheoretical model)
• Has given informed consent.

Exclusion Criteria:

• Assessed by a General Practitioner (GP):
• Underlying physical illness or mental disorder that may explain the symptoms.
• Suicide risk/previous suicide attempts.
• Pregnancy.
• Bedridden and in need of continuous care.
• Insufficient Norwegian speaking or writing skills to participate in the 3-day course and fill out questionnaires.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A 3-day course; The course consists of teaching in basic psychology, stress physiology and practice of a specific technique with self-instructions and visualization in a group setting by non-health personnel	Behavioral: A 3-day course; The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.
Active Comparator: Waiting list; Treatment as usual (TAU)	Behavioral: Waiting list; Treatment as usual (TAU) in the first 10 weeks. After 10 weeks: Behavioural: A 3-day course. The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Measured through the Short Form Health Survey (SF-36), physical function, a scale that measures physical function with questions relating to ability to perform physical activity. The instrument contains 10 items with three options on each question. The score range is 0 -100, where 100 is equivalent to no disability.	10 weeks after the 3-day course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Measured through the Chalder Fatigue Questionnaire, an instrument that measures fatigue severity, both on mental and physical fatigue in the last month. The instrument contains 11 items with four different response options in each question. The scale ranges from 0-33, where higher score indicates greater fatigue.	6 months after the 3-day course
Pain on a daily basis	Measured through the Brief Pain Inventory, an instrument measuring pain and its allied aspects. The instrument contains 11 items with numeric rating from 0-10, where higher score indicates more severe pain.	6 months after the 3-day course
Post-Exertional Malaise	Measured through A Brief Questionnaire to Assess Post-Exertional Malaise, an instrument that measures symptoms after activity. The instrument contains 10 items, with options ranging from 0-4, where a higher score indicates more severity.	6 months after the 3-day course
Mental wellbeing	Measured trough the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), an instrument that measures mental wellbeing. The instrument contains 14 items, with 5 response categories, summed to provide a single score. Higher score indicates better wellbeing.	6 months after the 3-day course
Overall improvement	Measured through the Patient Global Impression of Change (PGIC) with one single item that measures change in function, symptoms and quality of life. The instrument has seven possible options ranging from very much better to very much worse.	6 months after the 3-day course
Sick leave	Register data from the Norwegian Labour and Welfare Administration (NAV) on sick leave, benefits, diagnoses from 12 months before the 3-day course and 24 months after the 3-day course.	24 months after the 3-day course

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: University of Oslo; The Research Council of Norway; University of Bristol; Haukeland University Hospital; Lørenskog municipality
• Investigators: Principal Investigator: Leif Edward Ottesen Kennair, PhD prof, NTNU, Department of Psychology

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; RCT; Health education; Physical function; Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME); 3-day Course; Cognitive techniques; Behavioral activation
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Central Nervous System Infections; Syndrome; Fatigue; Myalgia; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: 394844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, along with the intervention protocol, will be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, Anonymized data can be shared with other researchers on reasonable request for use in specific research projects on CFS/ME after this study has been published. Due to privacy concerns, the complete data files will not be shared online.
• IPD Sharing Time Frame: The study protocol and the intervention protocol will be publicly available upon study completion.
• IPD Sharing Access Criteria: Anonymized data involving self-report data will be shared upon reasonable request from other researchers for use in specific research projects on CFS/ME when the main analyses are completed and published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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