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NCT Number: NCT05236465

A 3-day Course for CFS/ME

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.

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Key information

Conditions

Chronic Fatigue Syndrome Adherence Interventions Behavior Chronic Disease Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Health Behavior Health Education Medication Adherence Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, NTNU

Trondheim, Norway

Location status: Recruiting

Location contact

Leif Edward Ottesen Kennair, PhD prof

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A 3-day course

Behavioral

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.

Waiting list

Behavioral

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 outcomes

  1. Physical function

    Time frame: 10 weeks after the 3-day course

    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.

Secondary outcomes

  1. Fatigue

    Time frame: 6 months after the 3-day course

    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.

  2. Pain on a daily basis

    Time frame: 6 months after the 3-day course

    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.

  3. Post-Exertional Malaise

    Time frame: 6 months after the 3-day course

    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.

  4. Mental wellbeing

    Time frame: 6 months after the 3-day course

    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.

  5. Overall improvement

    Time frame: 6 months after the 3-day course

    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. Sick leave

    Time frame: 24 months after the 3-day course

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leif Edward Ottesen Kennair, PhD prof

CONTACT

[email protected]

+47 90557004

Live Landmark

CONTACT

[email protected]

+47 91855303

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haukeland University Hospital
  • Lørenskog municipality
  • The Research Council of Norway
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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