Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 17, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Fibromyalgia (FM)Chronic Migraine Headache
Interventions
BEHAVIORAL

Dynamic interpersonal therapy (DIT)

"Dynamic interpersonal therapy (DIT) is a dynamically oriented brief psychotherapeutic intervention based on attachment and mentalization theory that views symptoms of depression and anxiety as responses to interpersonal difficulties.~This intervention helps patients to understand the connection between their symptoms and their relationships by identifying a core, non-conscious, repetitive pattern of relating. Previous studies have shown positive results: significant reductions have been observed for the variables somatic symptom severity, depression, anxiety, and general psychiatric symptoms.~It consists of 16 sessions (one per week) for a total of 4 months."

BEHAVIORAL

technique of expressive writing (TSE)

"The expressive writing technique created by Pennebaker has shown beneficial health effects in different contexts since, through writing, it is possible to mentally reorganize a difficult event, allowing the mind to find meaning to what has happened or is happening. This technique can be a resource that can promote activation from the ability to recognize, express, and process the unspoken emotional, psychological, and relational, helping to achieve emotional and physiological feedback. Although the application of expressive writing in patients with fibromyalgia is an under-explored area of investigation in the international literature, several studies have shown its effectiveness in some chronic syndromes.~It consists of 8 meetings (one every fortnight) for a total of 4 months."

OTHER

Treatment as Usual (TAU)

The usual treatment involves two contacts by a rheumatologist/neurologist (depending on the clinical condition of the patient) during a four-month period, lasting about 10-15 minutes each, in which patients will be followed up medically. This treatment represents the active control group, planned to monitor specific aspects of the psychotherapeutic intervention, which aims to equate a good standard of primary care.

Trial Locations (2)

00100

ENROLLING_BY_INVITATION

Sapienza University of Rome, Rome

00185

RECRUITING

Department of Dynamic and Clinical Psychology and Health Studies, Rome

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Pavia

OTHER

collaborator

Azienda Policlinico Umberto I

OTHER

collaborator

Fondazione Mondino

OTHER

collaborator

University of Turin, Italy

OTHER

collaborator

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

lead

University of Roma La Sapienza

OTHER

NCT06652724 - Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache | Biotech Hunter | Biotech Hunter