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Pain and Stress Management for Fibromyalgia

2016年3月15日 更新者：Mark A. Lumley、Wayne State University

Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

230

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48106
        • University of Michigan Medical Center
      • Detroit、Michigan、アメリカ、48202
        • Wayne State University
      • Southfield、Michigan、アメリカ、48075
        • St. John Providence Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

    • 1990 ACR criteria including tender points
    • 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

  • Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
  • Other serious medical conditions that can impair health status independent of FM
  • Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
  • Alcohol/drug dependence in past 2 years
  • Cognitive impairment or dementia
  • Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
  • Unable to fluently read or converse in English
  • Planning to move from the area in the next 14 months
  • Judgment of principle investigator as not appropriate for this trial or all intervention arms

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
行動：Stress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
アクティブコンパレータ：Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
行動：Thoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
アクティブコンパレータ：Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
行動：Brain and Body
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.

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
Brief Pain Inventory
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

二次結果の測定

結果測定
時間枠
SF-12
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
PROMIS Fatigue short form
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Pittsburgh Sleep Quality Index
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Center for Epidemiological Studies - Depression Scale
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Generalized Anxiety Disorder - 7
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Positive and Negative Affect Schedule
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Satisfaction with Life Scale
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Multiple Ability Self-Report Questionnaire
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Patient Global Assessment of Change
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Health Care Utilization Scale
時間枠：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Real-time Physical Activity (Actiwatch)
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Heart Rate Variability
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Levels of Emotional Awareness Scale
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Emotional Expressivity Scale
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Ambivalence over Emotional Expression
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Impact of Events Scale - Revised
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
BBCA - short form
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Beliefs in Pain Control Questionnaire
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Communication Thoughts and Feelings Questionnaire
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Experimental (thumb nail pressure) threshold and tolerance ratings
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
2010 ACR modified clinical criteria for FM, including widespread pain index
時間枠：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Wayne State University

協力者

University of Michigan
St. John Providence Hospital

捜査官

  • 主任研究者：Mark A Lumley, Ph.D.、Wayne State University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年5月1日

一次修了 (実際)

2015年7月1日

研究の完了 (実際)

2015年7月1日

試験登録日

最初に提出

2010年11月2日

QC基準を満たした最初の提出物

2011年1月28日

最初の投稿 (見積もり)

2011年2月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年3月17日

QC基準を満たした最後の更新が送信されました

2016年3月15日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1R01AR057808 (米国 NIH グラント/契約)

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。

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