Clinical trial NCT05236465: A 3-day Course for CFS/ME
Official title: A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Health education
Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME)
RCT
3-day Course
Physical function
Fatigue
Cognitive techniques
Behavioral activation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Haukeland University Hospital
name: Lørenskog municipality
name: The Research Council of Norway
First posted: 2022-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or to the waiting list control group.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical function
timeFrame: 10 weeks after the 3-day course
Secondary outcomes:
measure: Fatigue
timeFrame: 6 months after the 3-day course
measure: Pain on a daily basis
timeFrame: 6 months after the 3-day course
measure: Post-Exertional Malaise
timeFrame: 6 months after the 3-day course
measure: Mental wellbeing
timeFrame: 6 months after the 3-day course
measure: Overall improvement
timeFrame: 6 months after the 3-day course
measure: Sick leave
timeFrame: 24 months after the 3-day course
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Psychology, NTNU
Study officials:
affiliation: NTNU, Department of Psychology
name: Leif Edward Ottesen Kennair, PhD prof
role: PRINCIPAL_INVESTIGATOR
References: