A 3-day Course for CFS/ME
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A 3-day course, Waiting list.
- Who it may be relevant to
- Registry conditions: Chronic Fatigue Syndrome, Myalgic Encephalomyelitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Physical function [Time frame: 10 weeks after the 3-day course]
Secondary outcome measures (6)
- Fatigue [Time frame: 6 months after the 3-day course]
- Pain on a daily basis [Time frame: 6 months after the 3-day course]
- Post-Exertional Malaise [Time frame: 6 months after the 3-day course]
- Mental wellbeing [Time frame: 6 months after the 3-day course]
- Overall improvement [Time frame: 6 months after the 3-day course]
- Sick leave [Time frame: 24 months after the 3-day course]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Department of Psychology, NTNU — Trondheim
Identifiers
NCT: NCT05236465 · 394844