Chronic Fatigue SyndromeNCT05236465
A 3-day Course for CFS/ME
A study testing A 3-day course and Waiting list in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- What is being tested?
- A 3-day course and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 21 Mar 2022to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Psychology, NTNU
Trondheim
Leif Edward Ottesen Kennair, PhD prof, kennair@ntnu.no
About this study
Official title: A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- A 3-day course, Waiting list
- Keywords
- Health education, Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME), RCT, 3-day Course, Physical function, Fatigue, Cognitive techniques, Behavioral activation
- Medical subject headings
- Fatigue Syndrome, Chronic, Health Education, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 3-day courseBehavioural
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 listBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A 3-day course | Experimental | 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 Receives: Behavioral: A 3-day course |
| Waiting list | Active comparator | Treatment as usual (TAU) Receives: Behavioral: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
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.
Measured: 10 weeks after the 3-day course
Secondary outcomes (6)
Fatigue
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.
Measured: 6 months after the 3-day course
Pain on a daily basis
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.
Measured: 6 months after the 3-day course
Post-Exertional Malaise
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.
Measured: 6 months after the 3-day course
Mental wellbeing
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.
Measured: 6 months after the 3-day course
Overall improvement
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.
Measured: 6 months after the 3-day course
Sick leave
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.
Measured: 24 months after the 3-day course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start21 Mar 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or to the waiting list control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Haukeland University Hospital, Lørenskog municipality, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Leif Edward Ottesen Kennair, PhD prof, Principal investigator, NTNU, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236465
- Sponsor's protocol ID
- 394844
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2022
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, along with the intervention protocol, will be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, Anonymized data can be shared with other researchers on reasonable request for use in specific research projects on CFS/ME after this study has been published. Due to privacy concerns, the complete data files will not be shared online.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05236465
- Acronym / sponsor ID
- 394844
- Keywords
- Health education, Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME), RCT, 3-day Course, Physical function, Fatigue, Cognitive techniques, Behavioral activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Oslo, Haukeland University Hospital, Lørenskog municipality, The Research Council of Norway
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or to the waiting list control group.
| Arm | Type | Receives |
|---|---|---|
| A 3-day course | Experimental | Behavioral: A 3-day courseThe 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 |
| Waiting list | Active comparator | Behavioral: Waiting listTreatment as usual (TAU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 3-day courseThe 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. | Behavioural | A 3-day course |
| Waiting listTreatment 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. | Behavioural | Waiting list |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. The study protocol, along with the intervention protocol, will be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, Anonymized data can be shared with other researchers on reasonable request for use in specific research projects on CFS/ME after this study has been published. Due to privacy concerns, the complete data files will not be shared online.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leif Edward Ottesen Kennair, PhD prof principal investigator
NTNU, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 3-day course and Waiting list in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leif Edward Ottesen Kennair, PhD prof (+47 90557004, kennair@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: 10 weeks after the 3-day course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.