- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00796536
Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry.
To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain.
Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Vermont
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Burlington, Vermont, Vereinigte Staaten, 05401
- MindBody Medicine Clinic
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back
- Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire
- Has ongoing standard pain management from a physician
- Agrees to participate in this research study
Exclusion Criteria:
- Malignancy
- Reflex sympathetic dystrophy and/or naturopathic pain
- Opioid medication use
- Substance use disorder
- Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study
- Major depression or/and dysthymia
- Post traumatic stress disorder or panic disorder
- Left-handedness
- Pregnancy
- History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition
- Exceeding the weight limit on the MRI scanner
- Suffering from claustrophobia
- Any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, intrauterine devices, shrapnel injuries
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 1
Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
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Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain.
These skills will include breathing exercises, distraction, and relaxation techniques.
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Aktiver Komparator: 2
Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan.
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Patients will receive mailed educational materials to their homes on a weekly basis.
Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back.
Pain education is the standard of care for most outpatient clinics.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
Zeitfenster: Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Acute pain perception and brain activation correlated with improvement in clinical outcomes
Zeitfenster: Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Magdalena R. Naylor, MD, PhD, MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R21AR055716 (US NIH Stipendium/Vertrag)
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