A 3-day Course for CFS/ME

Norwegian University of Science and Technology

Status: Enrolling

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Treatments: Behavioral: Waiting list; Behavioral: A 3-day course

Study type: Interventional

Funder types: Other

Identifiers

NCT05236465

394844

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

A 3-day course

Experimental group

Description:

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

Treatment:

Behavioral: A 3-day course

Waiting list

Active Comparator group

Description:

Treatment as usual (TAU)

Treatment:

Behavioral: Waiting list