Trial · NCT03461874
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of headaches frequency | 12 months | Reduction of headaches frequency in patients treated by Pharmacological therapy only compared to patients treated by Pharmacological treatment + ACT |
| Secondary | Difference in the proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline | 12 months | Difference in the proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline in the two groups. |
| Secondary | Medications intake | 3, 6, 12 months | Change in the number of medications for acute headaches treatment consumed. |
| Secondary | Change in disability scores, assessed with the Migraine Disability Assessment. | 6, 12 months | The Migraine Disability Assessment measures the impact of migraine headaches in terms of entirely missed workdays, partially missed workdays, entirely missed homework days, partially missed homework days and days with missed leisure/family activities. The score ranges between 0 and 270, with higher scores indicating higher disability; a score \>=21 indicates presence of relevant disability. |
| Secondary | Change in impact scores, assessed with the 6-item Headache Impact Test. | 6, 12 months | The 6-item Headache Impact Test measures the impact of headaches on patients' ability to function on the job, at school, at home and in social situations. It is composed of six items, which are rated on a six-level scores (never, rarely, sometimes, very often, always, which are respectively assigned a score of 6, 8, 10, 11, 13). The total score is given by the sum of single items score and ranges between 36 and 78, with higher scores indicating worse impact. A total score below 46 indicates no impact; score in the range 50-55 indicates minor impact; score in the range 56-59 indicates substantial impact; score equal or higher than 60 indicate severe impact. |
| Secondary | Change in in anxiety and depression scores, assessed with the Hospital Anxiety and Depression Scale. | 6, 12 months | The Hospital Anxiety and Depression Scale has two separate score for depression and anxiety, each composed of seven items that are rated 0-3. Both anxiety and depression sub-scores are defined as the sum to the response to item and range between 0 and 21, with higher scores indicating worse anxiety and depression problems. A score \>=8 is the cut-off for both anxiety and depression caseness. |
| Secondary | Change in allodynia, assessed with the Allodynia Symptom Checklist. | 6, 12 months | The Allodynia Symptom Checklist is composed of 12 items referring to the presence of allodynia, i.e. the clinical situation in which skin stimulation that ordinarily would not produce pain (e.g. wearing eyeglasses) is experienced as pain in the course of headache. Each item is rated on a 0-2 scale, and therefore the total checklist score is 0-24, with higher score indicating worse allodynia. Total score in the range 0-2 indicate no allodynia, those in the range 3-5 indicate mild allodynia, those in the range 6-8 indicate moderate allodynia and those \>= 9 indicate severe allodynia. |
| Secondary | Change in catastrophizing attitude, assessed with the Pain Catastrophizing Scale. | 6, 12 months | The Pain Catastrophizing Scale is composed of 13 items, that have to be rated between 0 and 4. The total score is given by the sum of the response to the items and therefore ranges between 0 and 52, with higher scores indicating higher tendency to catastrophizing, and a score \>= 30 indicates clinically relevant level of catastrophizing. |
| Secondary | Change in acceptance attitude, assessed with the Acceptance & Action Questionnaire, second version. | 6, 12 months | The Acceptance \& Action Questionnaire-2 is composed of seven items addressing psychological inflexibility, each item ranges between 1 and 7, with higher scores indicating greater levels of inflexibility. The questionnaire score ranges between 7 and 49, and a score of 24 is a proposed cut-off. |
| Secondary | Change in acceptance attitude, assessed with the Chronic Pain Acceptance Questionnaire. | 6, 12 months | The Chronic Pain Acceptance Questionnaire is a measure of acceptance and experiential avoidance, defined in terms of the person's ability to participate daily activities while acknowledging the presence of pain, and to allow the experience of pain with no efforts to avoid or control it. It is composed of 20 items rated between 0 and 6, and the questionnaire total score is given by the sum to each of them. Score ranges between 0 and 120, with higher scores indicating higher capacity to engage in activities with presence of pain and with no attempts to avoid or control it. |
| Secondary | Change in mindfulness, assessed with the Mindfulness Attention Awareness Scale. | 6, 12 months | The scale measures people's tendency to be mindful of moment to moment experience, i.e. it focuses on the presence of attention and awareness of what occurs in the present. It is composed of 15 items, rated on a 1-6 scale: thus overall score ranges between 15 and 90, with higher scores reflecting higher mindfulness (i.e. higher attention and awareness of what occurs in the present). |
| Secondary | Change in overall work productivity reduction. | 12 months | Work productivity reduction is a composite measure given by two sub-dimension, namely absenteeism and presenteeism. Absenteeism is calculated as the number of days in which the person did not get to work because of headache. Presenteeism is calculated as the number of days in which the person was at work, but worked with reduced efficiency due to the presence of migraine headache. To calculate presenteeism, patients have to refer the number of days in which they worked with lower ability due to headache, and have to provide an estimate of their average performance level on a 1-99% scale. The portion needed to reach 100% performance is the productivity reduction coefficient, which is multiplied by the number of days with presenteeism to get the overall presenteeism measure. The overall work productivity reduction is given by the sum of absenteeism and presenteeism. |
| Secondary | Risk of CM development | 12, 24 and 36 months | Proportion of patients meeting the criteria for Chronic Migraine and Medication Overuse Headache (1.3 and 8.2 of the ICHD-3beta). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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