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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Vermont
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Burlington、Vermont、アメリカ、05401
- MindBody Medicine Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
時間枠:Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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二次結果の測定
結果測定 |
時間枠 |
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Acute pain perception and brain activation correlated with improvement in clinical outcomes
時間枠:Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Magdalena R. Naylor, MD, PhD、MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性の痛みの臨床試験
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Dexa Medica Group完了