A 3-day Course for CFS/ME

Last updated: November 15, 2024
Sponsor: Norwegian University of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Fatigue Syndrome

Neurologic Disorders

Fibromyalgia

Treatment

Waiting list

A 3-day course

Clinical Study ID

NCT05236465
394844
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 transtheoreticalmodel)

  • Has given informed consent.

Exclusion

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 courseand fill out questionnaires.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Waiting list
Phase:
Study Start date:
March 21, 2022
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Department of Psychology, NTNU

    Trondheim,
    Norway

    Active - Recruiting

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