NCT04265196|Completed
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Sponsor study identifier
interventional
90
1 country
1
Study Start
April 4, 2019
Actual (reported)Primary Completion
October 1, 2021
Actual (reported)Study Completion
August 31, 2022
Actual (reported)This study was conducted as part of a collaboration between the Maccabi Health Fund and Bar Ilan University. Fibromyalgia is a chronic pain disorder, highly co-morbid with depression, stress, and anxiety. the investigators aim to examine the effect of group cognitive-behavioral therapy (CBT) and mindfulness-based intervention (MBI) among fibromyalgia patients. the investigators will also examine which intervention fits which patient, according to one's individual characteristics, in hope that this would enable Maccabi to offer personalized treatment. Furthermore, the investigators wish to identify the underlying cognitive and psychopathological mechanisms (measured during treatment) by which each intervention works.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2019
Actual (reported)February 2, 2020
Actual (reported)February 11, 2020
Actual (reported)October 1, 2021
Actual (reported)August 31, 2022
Actual (reported)The Fibromyalgia Impact Questionnaire Revised (FIQR)
Self-report questionnaire, which includes 21 items and assesses symptoms and functioning of fibromyalgia patients, taking into account the frequency of symptoms, their intensity, and the degree of impairment of patient function
change through study completion, an average of 6 month
Perceived Stress Scale (PSS)
A 10-item questionnaire measuring the level at which events occurred in the individual's life in the past month is perceived as unpredictable, uncontrollable and overwhelming. A higher score indicates a higher level of perceived stress.
change through study completion, an average of 6 month
The Patient Health Questionnaire-9 (PHQ-9)
A self-reported 9-item questionnaire to measure symptoms of major depression. The items relate to the key aspects of DSM, including thoughts of death, loss of appetite, sadness and mental pain, and negative cognitions.
change through study completion, an average of 6 month
Mindfulness (Five Fact Mindfulness Questionnaire)
change through study completion, an average of 6 month
Psychological Inflexibility in Pain (PIPS)
change through study completion, an average of 6 month
Body Vigilance (BVS)
change through study completion, an average of 6 month
Meta-cognition (MCQ-30)
change through study completion, an average of 6 month
Difficulties in emotion regulation (DERS)
change through study completion, an average of 6 month
A Cognitive Behavioral Therapy intervention is based on a unique protocol built in the light of previous research in the field and includes a 10-week treatment focused on coping with pain and stress.
A mindfulness-based group therapy intervention was built inspired by a mindfulness protocol that is effective in treating pain, and includes adjustments to the physical distress of fibromyalgia patients as well as an emphasis on coping with stress and pain.
A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain
Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain
Bar Ilan University
Ramat Gan, Israel
Danny Horesh, Phd
Bar Ilan University
90 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2020
First Posted
February 11, 2020
Study Start
DDBT Adapted Problem Solving Treatment for Primary Care
Pain (VAS)
Self-report questionnaire designed to measure pain intensity and unpleasantness caused by pain. This questionnaire is widely used in pain clinics. It includes one item that can be graded on a continuous scale that ranges from 0 (no pain) to 10 (the worst pain that can be).
change through study completion, an average of 6 month
Sleep Quality (Pittsburgh Sleep Quality Index)
A questionnaire developed to measure sleep quality and sleep disorder. The questionnaire includes 19 items measuring seven components of sleep (sleep quality, sleep onset, sleep duration, sleep efficiency, sleep disturbance, sleep medication use, and daily functioning impairment) over the past four weeks.
change through study completion, an average of 6 month
A control group will wait for 3 months, during which the subjects will complete the questionnaires and only after the end of the period will they participate in the treatment so that it will serve as a control group without intervention.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
April 4, 2019
Primary Completion
October 1, 2021
Actual (reported)Study Completion
August 31, 2022
Actual (reported)Last Updated
October 4, 2022
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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