Migraine Is More Than Just Headache: Is the Link to Chronic Fatigue and Mood Disorders Simply Due to Shared Biological Systems?
Nazia Karsan, Peter J Goadsby
https://pubmed.ncbi.nlm.nih.gov/34149377/Actively Recruiting
Led by University of Roma La Sapienza · Updated on 2024-10-22
400
Participants Needed
2
Research Sites
N/A
Total Duration
This research focuses on chronic pain conditions, specifically fibromyalgia FM and chronic migraine CM, which often involve nociplastic pain characterized by altered pain processing without obvious tissue damage. The study aims to identify distinctive psychological and neurofunctional patterns in people with FM, CM, and those with both conditions FibroMig to improve chronic pain management. It also evaluates how brief psychodynamic treatments may influence pain severity, mental health symptoms, and quality of life. Participants are divided into three groups receiving different interventions over four months Dynamic Interpersonal Therapy DIT with 16 weekly sessions, Expressive Writing Therapy TSE with 8 biweekly sessions, and a control group receiving usual medical care with two brief specialist visits. The study includes two main parts one observes psychological and brain function differences among groups, and the other tests the effectiveness of the psychotherapeutic treatments on various measures. Throughout the study, participants complete surveys at enrollment, after the interventions, and six months post-intervention to assess pain severity, symptom severity, mental pain, anxiety and depression, central sensitization, alexithymia, and quality of life. Additional baseline assessments include personality traits, trauma history, and attachment style. The research helps understand chronic pain mechanisms and evaluates psychological therapies impact over a total participation time of about 10 months.
CONDITIONS
Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
F
Federica Galli, Professor
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Roma La Sapienza
Lead Sponsor
University of Pavia
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive one of three interventions: Dynamic interpersonal therapy (DIT) involving 16 weekly sessions, expressive writing therapy (TSE) involving 8 sessions every two weeks, or treatment as usual (TAU) involving two medical follow-up contacts over four months.
16 weekly sessions for DIT, 8 sessions every two weeks for TSE, or 2 medical follow-up visits for TAU
Duration - 6 months
Participants complete assessments to evaluate pain severity, symptoms, mental pain, psychopathological symptoms, alexithymia, and quality of life immediately after treatment and again 6 months later.
2 assessment visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Nazia Karsan, Peter J Goadsby
https://pubmed.ncbi.nlm.nih.gov/34149377/Mary-Ann Fitzcharles, Steven P Cohen, Daniel J Clauw...
https://pubmed.ncbi.nlm.nih.gov/34062144/Michael E Geisser, Cathy Strader Donnell, Frank Petzke...
https://pubmed.ncbi.nlm.nih.gov/18448779/Bethea A Kleykamp, McKenzie C Ferguson, Ewan McNicol...
https://pubmed.ncbi.nlm.nih.gov/33383293/Frederick Wolfe, Daniel J Clauw, Mary-Ann Fitzcharles...
https://pubmed.ncbi.nlm.nih.gov/27916278/Soo-Jin Cho, Serge Perrot, Jong-Hee Sohn...
https://pubmed.ncbi.nlm.nih.gov/30566656/Michel D Ferrari, Peter J Goadsby, Rami Burstein...
https://pubmed.ncbi.nlm.nih.gov/35027572/Marina de Tommaso, Vittorio Sciruicchio
https://pubmed.ncbi.nlm.nih.gov/26717950/I-Wen Penn, Eric Chuang, Tien-Yow Chuang...
https://pubmed.ncbi.nlm.nih.gov/30962236/Jes Olesen
https://pubmed.ncbi.nlm.nih.gov/29550365/University of Roma La Sapienza
Lead Sponsor
University of Pavia
Collaborating Sponsor