Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT07050758
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 (inclusive)
* Qualifying for Chronic Widespread Pain (CWP), as described in ICD-11 (an existing diagnosis of fibromyalgia qualifies for CWP)
* Baseline pain with an average intensity of at least 4/10 that has lasted for 3 months or longer
* If on medication that could potentially interfere with study participation or outcomes as evaluated by the study physician, stable doses of medication for 6 weeks prior to entering the study and during participation
* Living in Norway
* Fluent in Norwegian
* Normal or corrected-to-normal vision
* Access to smartphone or equivalent for use of app during study
Exclusion Criteria:
* Current comorbid acute pain condition (pain from acute illness, injury, infection, or similar in the past 3 weeks)
* Beck Depression Index (BDI) score more than 30
* Clinical high risk for suicidality (BDI short form item 7 on suicidality rated ≥ 2, or modaterate/high scores for suicidality in M.I.N.I. interview)
* Current psychological therapy for pain or mental health purposes
* Any current or past diagnosis and/or significant symptoms of psychosis-related disorders (schizophrenia, schizoaffective disorder), bipolar disorder, autism spectrum disorder, personality disorder
* Current diagnosis and/or significant symptoms of post-traumatic stress disorder (PTSD), eating disorder, substance use disorder, obsessive-compulsive disorder (OCD)
* Currently participating in other therapeutic trials
* Currently in a legal process regarding disability benefits.
* Currently pregnant
* Started an antidepressant or changed dose in the past 6 weeks
* Inability to reliably complete tasks related to the study
* Any impairment, activity or situation that in the judgement of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07050758
Study Brief:
Protocol Section:
NCT07050758