Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-03-21
2028-12-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A 3-day course
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
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.
Waiting list
Treatment as usual (TAU)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
University of Oslo
OTHER
Haukeland University Hospital
OTHER
Lørenskog municipality
UNKNOWN
The Research Council of Norway
OTHER
Responsible Party
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Principal Investigators
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Leif Edward Ottesen Kennair, PhD prof
Role: PRINCIPAL_INVESTIGATOR
NTNU, Department of Psychology
Locations
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Department of Psychology, NTNU
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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394844
Identifier Type: -
Identifier Source: org_study_id
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