Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline |
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms. |
12 weeks |
|
Secondary |
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline |
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms. |
24 weeks |
|
Secondary |
Sleep quality |
Changes in sleep pattern on actigraphy between treatment groups |
12 weeks |
|
Secondary |
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline |
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms. |
52 weeks |
|
Secondary |
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline |
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms. |
12 weeks |
|
Secondary |
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline |
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms. |
24 weeks |
|
Secondary |
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline |
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms. |
52 weeks |
|
Secondary |
Change in Tampa Scale of Kinesiophobia (TSK) from baseline |
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement. |
12 weeks |
|
Secondary |
Change in Tampa Scale of Kinesiophobia (TSK) from baseline |
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement. |
24 weeks |
|
Secondary |
Change in Tampa Scale of Kinesiophobia (TSK) from baseline |
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement. |
52 weeks |
|
Secondary |
Cost-effectiveness of dCBT-I |
Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£). |
12 weeks |
|
Secondary |
Cost-effectiveness of dCBT-I |
Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£). |
24 weeks |
|
Secondary |
Changes in brain structure |
Change in brain grey matter volume on structural MRI |
12 weeks |
|
Secondary |
Changes in brain functional connectivity |
Changes in brain resting state functional connectivity on resting-state functional MRI |
12 weeks |
|
Secondary |
Changes in neurotransmitter concentration in the insular |
Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy |
12 weeks |
|
Secondary |
Changes in brain function |
Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI |
12 weeks |
|