Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06652724

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

Led by University of Roma La Sapienza · Updated on 2024-10-22

400

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Roma La Sapienza

Lead Sponsor

U

University of Pavia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Minimum age of 18 years
  • At least 5 years of education
  • Diagnosis of fibromyalgia according to Wolfe (2016) for the FM group
  • Diagnosis of chronic migraine according to Olesen (2018) for the CM group
  • Medical certification of fibromyalgia and chronic migraine diagnosis for the FibroMig group
Not Eligible

You will not qualify if you...

  • Severe psychiatric disorders or cognitive impairment
  • Difficulty understanding or expressing in Italian
  • History of other chronic pain disorders for FM and CM groups
  • History of neurological disorders other than migraine for CM and FibroMig groups
  • History of rheumatological disorders other than fibromyalgia for FM and FibroMig groups
  • Healthy controls must have no diagnosis of FM or CM, no severe psychiatric disorders or cognitive impairment, low or no depression, and no history of rheumatological or neurological disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 2 locations

1

Sapienza University of Rome

Rome, RM, Italy, 00100

Enrolling by Invitation

2

Department of Dynamic and Clinical Psychology and Health Studies

Rome, RM, Italy, 00185

Actively Recruiting

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Research Team

F

Federica Galli, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Short-Term Psychodynamic Psychotherapy for Functional Somatic Disorders: A Meta-Analysis of Randomized Controlled Trials.

Allan Abbass, Joel Town, Hannah Holmes...

https://pubmed.ncbi.nlm.nih.gov/32428905

Central sensitivity in fibromyalgia: testing a model to explain the role of psychological factors on functioning and quality of life.

Filippo Maria Nimbi, Alessia Renzi, Erika Limoncin...

https://pubmed.ncbi.nlm.nih.gov/38607679

The Prevalence of Psychiatric and Chronic Pain Comorbidities in Fibromyalgia: an ACTTION systematic review.

Bethea A Kleykamp, McKenzie C Ferguson, Ewan McNicol...

https://pubmed.ncbi.nlm.nih.gov/33383293

Comorbid somatic symptoms and functional status in patients with fibromyalgia and chronic fatigue syndrome: sensory amplification as a common mechanism.

Michael E Geisser, Cathy Strader Donnell, Frank Petzke...

https://pubmed.ncbi.nlm.nih.gov/18448779