Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders (CAST-O)
2020年11月3日 更新者:Amanda M. Raines、Southeast Louisiana Veterans Health Care System
Evaluating the Utility of a Brief Computerized Anxiety Sensitivity Intervention for Opioid Use Disorders: A Pilot Investigation
The primary aim of the current project is to test the acceptability and feasibility of a computerized intervention, titled Computerized Anxiety Sensitivity Treatment (CAST), delivered to Veterans seeking treatment for an opioid use disorder.
The second aim of the study is to examine the utility of CAST by gathering data on symptom change.
The final aim of the current study is to test the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.
研究概览
详细说明
The pilot project will examine the effects of a brief, one-session computerized intervention delivered to Veterans seeking treatment for an opioid use disorder.
The opioid epidemic in the United States (US) is having a disproportionate impact on Veterans.
Indeed, Veterans are twice as likely to die from an accidental opioid overdose than members of the general population, even after accounting for gender and age distribution.
Although many individuals with an opioid addiction seek treatment, a large proportion drop out prematurely and/or relapse, highlighting the need to identify modifiable factors that may contribute to this process.
One variable that may be useful in understanding attrition in addiction treatment is anxiety sensitivity (AS).
AS is a well-established psychological risk factor reflecting the tendency to fear anxious arousal due to the belief that this arousal will have harmful physical, mental, and/or social consequences.
AS is elevated in opioid use populations and predicts treatment dropout among opioid users.
Importantly, research suggests that AS is highly malleable.
Despite this, to our knowledge no published research to date has systematically explored the utility of AS reduction protocols among opioid users.
The first aim of the current project is to test the acceptability and feasibility of a brief, one-session Computerized AS Treatment (CAST) delivered to Veterans seeking treatment for an opioid use disorder.
Because this is a pilot project and the study will likely be underpowered to detect treatment effects, we will not emphasize symptom reduction.
Nevertheless, a second aim of the current project is to examine the utility of CAST by gathering data on symptom change.
Finally, a third aim of the current project is to examine the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.
研究类型
介入性
注册 (实际的)
32
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。
学习地点
-
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Louisiana
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New Orleans、Louisiana、美国、70119
- Southeast Louisiana Veterans Health Care System
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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
Inclusion Criteria:
- Veterans must be diagnosed with an opioid use disorder
Exclusion Criteria:
- Less than 18 years of age
- Actively suicidal
- Actively psychotic
- Uncontrolled bipolar disorder (i.e., not stable on medications for at least one month)
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Computerized Anxiety Sensitivity Treatment
CAST is a newly developed computerized intervention designed to closely model the educational and behavioral techniques that are commonly used in the treatment of anxiety and related conditions.The one time intervention takes approximately 45 minutes to complete.
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CAST is a newly developed computerized intervention designed to closely model the educational and behavioral techniques that are commonly used in the treatment of anxiety and related conditions.
A psychoeducation component focuses on the nature of anxiety and its effects on the mind and body.
Veterans will be taught that physiological and psychological arousal is not dangerous, although they may have developed a conditioned fear of this arousal.
Interoceptive exposure (IE) exercises will also be introduced to as a way to reduce or eliminate the conditioned fear response.
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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 |
---|---|---|
Intervention Acceptability Questionnaire (IAQ)
大体时间:One week post-intervention
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The IAQ is an 11-item self-report questionnaire designed to measure treatment satisfaction.
The IAQ includes nine items assessing acceptability (e.g., Do you think the information provided during the computerized intervention was helpful?
How likely are you to use the information and techniques you learned during the computerized intervention?), which are rated on a 4-point Likert-type scale (0 = no; 1 = somewhat; 2 = moderately; 3 = yes) and two free response items requesting suggestions for improving the treatment.
The IAQ will be administered at post-intervention to allow us to assess treatment acceptability.
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One week post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Alcohol Use Disorders Identification Test (AUDIT)
大体时间:Baseline
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The AUDIT is a 10-item self-report questionnaire designed by the World Health Organization to classify individuals with alcohol-related problems.
The AUDIT will be administered at baseline for descriptive purposes.
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Baseline
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Drug Use Disorders Identification Test (DUDIT)
大体时间:Baseline
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The DUDIT is an 11-item self-report questionnaire intended for use with the AUDIT as a way to classify individuals with drug-related problems.
The DUDIT will be administered at baseline for descriptive purposes
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Baseline
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PTSD Checklist for DSM-5 (PCL-5)
大体时间:Baseline
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The PCL-5 is a 20-item self-report questionnaire designed to assess DSM-5 symptoms of PTSD.
The PCL-5 will be administered at baseline for descriptive purposes.
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Baseline
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Anxiety Sensitivity Index-3 (ASI-3)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The ASI-3 is an 18-item self-report questionnaire designed to measure fear of and concern about the negative effects of anxious arousal.
The ASI-3 will be administered at all timepoints to allow us to assess treatment-related changes in AS.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Depression Anxiety Stress Scale (DASS)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The DASS is a 21-item self-report questionnaire assessing depression, anxiety, and stress symptoms.
The DASS will be administered at all timepoints to allow us to assess treatment-related changes in depression, anxiety, and stress symptoms.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Depression Symptom Inventory-Suicide Subscale (DSI-SS)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The DSI-SS is a four-item self-report questionnaire designed to assess suicidal ideation, suicidal plans, control of suicidal thoughts, and suicidal impulses.
The DSI-SS will be administered at all timepoints to allow us to assess treatment-related changes in suicidality.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Desires for Drug Questionnaire (DDQ)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The DDQ is a 13-item self-report questionnaire designed to measure instant (i.e., present moment) cravings associated with opioid use.
The DDQ will be administered at all timepoints to allow us to assess treatment-related changes in cravings.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Obsessive Compulsive Drug Use Scale (OCDUS)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The OCDUS is a 12-item self-report questionnaire designed to assess heroin thoughts and interference, intention to use heroin and control of its consumption, and resistance against thoughts and decisions to use heroin.
The OCDUS will be administered at all timepoints to allow us to assess treatment related changes in thoughts and control over thoughts.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Short Opiate Withdrawal Scale (SOWS)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The SOWS is a 10-item self-report questionnaire designed to assess various symptoms of opiate withdrawal.
The SOWS will be administered at all timepoints to allow us to assess treatment-related changes in withdrawal symptoms.
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Baseline, One week post-intervention, and Four weeks post-intervention
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Work and Social Adjustment Scale (WSAS)
大体时间:Baseline, One week post-intervention, and Four weeks post-intervention
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The WSAS is a 5-item descriptive measure of subjective interference of psychiatric symptoms in various life domains (e.g., work, leisure, and family).
The WSAS will be administered at all timepoints to allow us to assess treatment-related changes in global life domains.
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Baseline, One week post-intervention, and Four weeks post-intervention
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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:Amanda M Raines, PhD、Southeast Louisiana Veterans Health Care System
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
- Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011 Apr 6;305(13):1315-21. doi: 10.1001/jama.2011.370.
- Keough ME, Schmidt NB. Refinement of a brief anxiety sensitivity reduction intervention. J Consult Clin Psychol. 2012 Oct;80(5):766-72. doi: 10.1037/a0027961. Epub 2012 Apr 2.
- Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.
- Schmidt NB, Eggleston AM, Woolaway-Bickel K, Fitzpatrick KK, Vasey MW, Richey JA. Anxiety Sensitivity Amelioration Training (ASAT): a longitudinal primary prevention program targeting cognitive vulnerability. J Anxiety Disord. 2007;21(3):302-19. doi: 10.1016/j.janxdis.2006.06.002. Epub 2006 Aug 4.
- Hearon BA, Calkins AW, Halperin DM, McHugh RK, Murray HW, Otto MW. Anxiety sensitivity and illicit sedative use among opiate-dependent women and men. Am J Drug Alcohol Abuse. 2011 Jan;37(1):43-7. doi: 10.3109/00952990.2010.535581. Epub 2010 Nov 19. Erratum In: Am J Drug Alcohol Abuse. 2011 Jan;37(1):47.
- Bohnert AS, Ilgen MA, Galea S, McCarthy JF, Blow FC. Accidental poisoning mortality among patients in the Department of Veterans Affairs Health System. Med Care. 2011 Apr;49(4):393-6. doi: 10.1097/MLR.0b013e318202aa27.
- Veilleux JC, Colvin PJ, Anderson J, York C, Heinz AJ. A review of opioid dependence treatment: pharmacological and psychosocial interventions to treat opioid addiction. Clin Psychol Rev. 2010 Mar;30(2):155-66. doi: 10.1016/j.cpr.2009.10.006. Epub 2009 Oct 30.
- Reiss, S. and R. McNally, Expectancy model of fear, in Theoretical Issues in Behavior Therapy, S. Reiss and R. Bootzin, Editors. 1985, Academic Press: San Diego, CA. p. 107-122.
- Lejuez CW, Paulson A, Daughters SB, Bornovalova MA, Zvolensky MJ. The association between heroin use and anxiety sensitivity among inner-city individuals in residential drug use treatment. Behav Res Ther. 2006 May;44(5):667-77. doi: 10.1016/j.brat.2005.04.006. Epub 2005 Jul 5.
- Lejuez CW, Zvolensky MJ, Daughters SB, Bornovalova MA, Paulson A, Tull MT, Ettinger K, Otto MW. Anxiety sensitivity: a unique predictor of dropout among inner-city heroin and crack/cocaine users in residential substance use treatment. Behav Res Ther. 2008 Jul;46(7):811-8. doi: 10.1016/j.brat.2008.03.010. Epub 2008 Mar 28.
- Schmidt NB, Norr AM, Allan NP, Raines AM, Capron DW. A randomized clinical trial targeting anxiety sensitivity for patients with suicidal ideation. J Consult Clin Psychol. 2017 Jun;85(6):596-610. doi: 10.1037/ccp0000195. Epub 2017 Mar 13.
- Barlow, D.H., et al., Behavioral treatment of panic disorder. Behavior Therapy, 1989. 20(2): p. 261-282.
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)
2019年5月28日
初级完成 (实际的)
2020年1月10日
研究完成 (实际的)
2020年1月31日
研究注册日期
首次提交
2019年5月6日
首先提交符合 QC 标准的
2019年5月7日
首次发布 (实际的)
2019年5月10日
研究记录更新
最后更新发布 (实际的)
2020年11月5日
上次提交的符合 QC 标准的更新
2020年11月3日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 365
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Data sets underlying this project will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA), for a number of reasons.
First, data will be used by the research team to answer additional research questions.
Further, veterans may be hesitant to participate in research in which the data will be shared outside the VA and this may act as a barrier to participation and/or benefit from treatment.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
阿片类药物使用障碍的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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