针对饮食失调的非体重不足成人的 MICBT (MICBT-ED)
2022年8月12日 更新者:GLORIA FIORAVANTI、Centro Trattamento Integrato: Disturbi Alimentari e Obesita
CBT-E 与 CBT-F+元认知人际关系疗法针对患有饮食失调的非体重不足成人:一项随机对照试验的研究方案
饮食失调 (ED) 是一种严重但可治疗的疾病,但在疗效和依从性方面还有很大的改进余地。
有空间探索新的治疗方案,这些方案要么更有能力让患者接受治疗,要么更有效。
或者,它们的疗效可能与当前可用的治疗方法相匹配,但为那些对现有疗法没有反应的治疗方法提供了新的选择。
在这里,研究人员探讨了以 CBT 为重点的元认知人际关系疗法 (MIT) 的组合是否是一种经验支持的人格障碍疗法,并且可能成为非体重不足 ED 的一种新的可行治疗方案。
麻省理工学院针对 ED 的某些方面,例如对精神状态和适应不良的人际模式的认识不足,这些方面未包含在跨诊断模型中,该模型是 CBT-E 研究最多的经验支持的 ED 治疗的基础。
因此,针对精神病理学的这些方面可以成为治疗依从性和有效性的途径是合理的
研究概览
详细说明
该研究是一项试点随机对照试验,旨在评估每周 MIT 在一组诊断为 ED 的成年人中对 CBT-F 成瘾的可行性和有效性。 具体来说,研究人员将在出现 ED 的非体重不足的成年人样本中调查,与 CBT-E 相比,MIT 和 CBT-F 相结合的治疗是否 a) 可行,b) 耐受性良好,c) 对进食可能有效障碍症状和其他结果。
研究者在以往对人格障碍进行MIT研究的基础上,期望CBT-F+MIT实验组能够有较高的治疗依从性和保持率。 他们还将期望主要结果有好的结果。 鉴于样本量小,这只是一项试点研究,因此关于其他结果的任何结论都将被视为初步的。 结果将提供新的证据,可能导致将 CBT-F + MIT 视为 ED 的治疗选择,值得在更大规模的试验中进行研究。
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Gloria Fioravanti
- 电话号码:+39 348 9255483
- 邮箱:info@gloriafioravanti.it
学习地点
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VR
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Verona、VR、意大利、37100
- 招聘中
- Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
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接触:
- Gloria Fioravanti
- 电话号码:+39 348 9255483
- 邮箱:info@gloriafioravanti.it
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副研究员:
- Giancarlo Dimaggio
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副研究员:
- Angus MacBeth
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副研究员:
- Martina Nicolis
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 在过去 6 个月内诊断出 ED
- 寻求饮食失调治疗
- 能够提供书面的知情同意
- 体重指数 > 18.5
排除标准:
- 急性精神病发作、精神病症状、I型双相情感障碍;反社会人格障碍
- 自杀意念
- 药物滥用
- 先前对其他饮食失调的心理干预
- 目前参与其他正在进行的治疗
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:CBT-E
CBT-E 条件下的参与者将在 20 周内接受总共 20 次 CBT-E 课程。
CBT-E 治疗将包括四个阶段。
特别是,CBT 旨在告知患者自我控制的重要性,以及一些限制性行为(如自我催吐)的危险。
此外,CBT 为患者提供策略以监测他们通常的功能失调行为,从而提高他们的意识(即
食物日记法),同时减少食物的供应并鼓励与暴饮暴食不相容的活动。
患者将接受解决问题的培训,以改变这些感受,以及提高他们的自我意识,以识别关于他们的体重和体型的非理性想法。
此外,他们将逐渐接触到他们一直避免的食物。
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在第一阶段,治疗的重点是达成对患者进食障碍和相关维持因素的共同理解。
在此阶段,将帮助患者调节和稳定他的饮食习惯,从而解决他的体重问题。
在第二阶段,详细审查取得的进展。
在第三阶段,会议将侧重于维持患者进食障碍精神病理学的中枢过程。
特别是,这涉及解决对体重和体型、认知和热量饮食限制、影响营养的事件和情绪的担忧。
在第三和第四阶段的临床完善中,还解决了整体自尊心低下、情绪不容忍和人际关系困难的问题。
在第三阶段末和第四阶段期间,还将实施程序以尽量减少短期和长期复发的风险。
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实验性的:CBT-F+麻省理工学院
CBT-F+MIT 条件下的参与者将在 20 周内接受总共 20 节课。 具体而言,2 节课将照常仅基于 CBT-F。 在这些课程中,参与者将接受关于饮食行为的心理教育培训,并介绍协议工具,即监测表、体重图表、跨诊断公式和饮食问题检查表 (EPCL)。 这些元素将在其余 18 节课的开始时使用,以监测饮食行为的规定以及引出叙事情节。 这些材料将构成会议 MIT 部分的基础,治疗师将寻求与患者就其 ED 症状及其适应不良的人际功能背后的心理原因达成共识。 MIT 课程将整合到 CBT-F 协议中,该协议将为 ED 提供心理教育、营养再教育和管理。 |
目的是制定更健康的策略来管理 ED 之前的负面想法和感受,并让患者参与满足他们关系基本愿望的社交互动。
因此,他们将理解,他们通过 ED 体验到的完美主义和对控制的需求是在与重要他人互动的人际模式中发展起来的应对策略,其中低自尊和情绪失调起着核心作用。
麻省理工学院旨在提高个人理解自己的影响和认知的能力,并意识到自己和他人被适应不良、僵化和有偏见的图式所驱使,从而形成对他人思想的更丰富的理解,并利用这些知识来以更具适应性的方式对社会困难或进化选择的愿望做出反应。
麻省理工学院还使个人能够反思这些图式如何作为 ED 行为的触发器,并制定更有效的应对人际关系压力的策略。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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饮食失调检查问卷(EDE-Q6;Fairburn & Beglin,1994)
大体时间:从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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评估过去 4 周饮食失调的自我报告措施,提供饮食失调特征严重程度范围的衡量标准。
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从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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饮食态度测试(EAT-26;Garner & Garfinkel,1979)
大体时间:从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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一种基于与饮食相关的态度、感受和行为来识别“饮食失调风险”存在的自我报告措施。
它评估一般饮食行为和危险行为。
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从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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临床损伤评估问卷(CIA 3.0;Bohn 和 Fairburn,2008 年)。
大体时间:从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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自我报告措施 f 评估过去 28 天内饮食失调特征导致的社会心理损害的严重程度。
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从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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暴食量表(BES;Gormally 等人,1992)
大体时间:从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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客观暴食 (OBE) 的行为、认知和情绪特征的自我报告问卷。
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从基线到 10 个疗程后、治疗结束时以及治疗后 3、6、12、18 和 24 个月的变化。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
状态-特质焦虑量表(STAI;Spielberger、Gorsuch、Lushene、Vagg 和 Jacobs,1983)
大体时间:在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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特质和状态焦虑的自我报告测量。
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在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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贝克抑郁量表 (BDI; Beck, et al., 1961)
大体时间:在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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抑郁症的自我报告措施。
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在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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症状检查表 (SCL-90)
大体时间:在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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衡量精神病理学症状及其在特定时间点的强度。
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在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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情绪调节困难量表(DERS;Gratz & Roemer,2004)
大体时间:在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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一种自我报告量表,衡量个体在识别、接受和管理情绪体验的能力上的差异。
这项措施有助于了解可能导致疾病的情绪失调。
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在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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DSM-5 障碍的结构化临床访谈(SCID-5;Michael B. First,Janet B.W. Williams)
大体时间:在基线
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用于评估和定义人格障碍的 DSM-5 模型。
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在基线
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多伦多述情障碍量表(TAS - 20;Taylor & Bagby,1992)
大体时间:在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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它评估理解、处理或描述情绪的困难
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在基线、10 个疗程后、治疗结束时以及治疗后的 3、6、12、18 和 24 个月。
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工作联盟清单 - 修订版(WAI;SR Hatcher & Gillaspy,2006)
大体时间:每 4 周一次
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它通过评估治疗联盟的三个主要方面来衡量治疗联盟:对治疗任务的同意、对治疗目标的同意以及情感纽带的发展。
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每 4 周一次
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Gloria Fioravanti、Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
- 研究主任:Raffaele Popolo、Centro di Terapia Metacognitiva Interpersonale, Roma
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Palmer RL, Dalle Grave R. Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. Behav Res Ther. 2013 Jan;51(1):R2-8. doi: 10.1016/j.brat.2012.09.010. Epub 2012 Oct 22.
- Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Bohn K, Hawker DM, Wales JA, Palmer RL. Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up. Am J Psychiatry. 2009 Mar;166(3):311-9. doi: 10.1176/appi.ajp.2008.08040608. Epub 2008 Dec 15.
- Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23. Erratum In: Psychol Med. 2014 Aug;44(11):2462-3.
- BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
- Fairburn CG, Bailey-Straebler S, Basden S, Doll HA, Jones R, Murphy R, O'Connor ME, Cooper Z. A transdiagnostic comparison of enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy in the treatment of eating disorders. Behav Res Ther. 2015 Jul;70:64-71. doi: 10.1016/j.brat.2015.04.010. Epub 2015 Apr 22.
- Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.
- Dalle Grave R, Calugi S, Conti M, Doll H, Fairburn CG. Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial. Psychother Psychosom. 2013;82(6):390-8. doi: 10.1159/000350058. Epub 2013 Sep 20.
- Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
- Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- Fairburn CG, Patel V. The global dissemination of psychological treatments: a road map for research and practice. Am J Psychiatry. 2014 May;171(5):495-8. doi: 10.1176/appi.ajp.2013.13111546. No abstract available.
- Poulsen S, Lunn S, Daniel SI, Folke S, Mathiesen BB, Katznelson H, Fairburn CG. A randomized controlled trial of psychoanalytic psychotherapy or cognitive-behavioral therapy for bulimia nervosa. Am J Psychiatry. 2014 Jan;171(1):109-16. doi: 10.1176/appi.ajp.2013.12121511.
- Dalle Grave R, Calugi S, Doll HA, Fairburn CG. Enhanced cognitive behaviour therapy for adolescents with anorexia nervosa: an alternative to family therapy? Behav Res Ther. 2013 Jan;51(1):R9-R12. doi: 10.1016/j.brat.2012.09.008. Epub 2012 Oct 4.
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- Lilenfeld LR, Kaye WH, Greeno CG, Merikangas KR, Plotnicov K, Pollice C, Rao R, Strober M, Bulik CM, Nagy L. A controlled family study of anorexia nervosa and bulimia nervosa: psychiatric disorders in first-degree relatives and effects of proband comorbidity. Arch Gen Psychiatry. 1998 Jul;55(7):603-10. doi: 10.1001/archpsyc.55.7.603.
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- Rastam M. Anorexia nervosa in 51 Swedish adolescents: premorbid problems and comorbidity. J Am Acad Child Adolesc Psychiatry. 1992 Sep;31(5):819-29. doi: 10.1097/00004583-199209000-00007.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月31日
初级完成 (预期的)
2023年5月31日
研究完成 (预期的)
2024年11月30日
研究注册日期
首次提交
2022年8月11日
首先提交符合 QC 标准的
2022年8月12日
首次发布 (实际的)
2022年8月17日
研究记录更新
最后更新发布 (实际的)
2022年8月17日
上次提交的符合 QC 标准的更新
2022年8月12日
最后验证
2022年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
CBT-E的临床试验
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); University of Utah完全的
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Shalvata Mental Health CenterUniversity of Haifa; The Touro College and University System未知暴饮暴食症 | 神经性贪食症 | 夜食综合症
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Federal University of São PauloUniversity of Western Sydney完全的
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Norwegian School of Sport SciencesUniversity of Tromso; The Norwegian Women´s Public Health Association完全的
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University of LouisvilleNational Institute of Mental Health (NIMH)招聘中
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht University; University... 和其他合作者招聘中