跳至主要内容
临床试验/NCT05117255
NCT05117255招募中不适用

Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity

University of Minnesota1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2022年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
256
试验地点
1
主要终点
Percent heavy ("binge") days drinking

研究概览

简要总结

This project is designed to determine if a computer-delivered cognitive-behavioral treatment can improve the otherwise poor alcohol use disorder treatment outcomes for individuals with a co-occurring anxiety disorder. In the past, the investigators showed that this treatment does improve outcomes for these individuals when delivered by a therapist. If the present work shows that the computer-delivered version is also effective, it would provide an inexpensive program with virtually unlimited scalability to enable access to the treatment by many more individuals than is currently the case.

详细描述

The broad goal of the proposed work is to conduct a randomized controlled trial of a specialized computer-delivered cognitive-behavioral therapy (CBT) to supplement standard alcohol use disorder (AUD) treatment in patients with a co-occurring anxiety disorder ("comorbidity"). Comorbidity is both common in AUD treatment patients (up to 50%) and confers a substantial increase in the risk of a return to drinking in the months following treatment. Because research shows that simply adding a standard psychiatric treatment does not substantially improve the AUD outcomes of comorbid individuals, the investigators developed a CBT-based intervention aimed at disrupting the positive-feedback loop ("vicious cycle"; VC) of mutually aggravating negative affect and drinking behavior/urges (the "VC-CBT"). In an Randomized Controlled Trial (RCT), AUD treatment patients who received the therapist-delivered VC-CBT demonstrated significantly improved alcohol use outcomes as compared to those who received a standard anxiety treatment. Unfortunately, most community-based AUD treatment programs do not have clinical staff with the specialized training and technical expertise needed to deliver the VC-CBT. To help bridge this "research-to-practice" gap, the investigators went on to develop a fully autonomous and interactive computer-delivered version of the VC-CBT and have demonstrated its functionality in AUD patients. Now, the investigators propose to test the clinical efficacy of the computer-delivered VC-CBT, as well as the mechanisms and processes by which it is hypothesized to work. Aim I is a randomized controlled trial comparing the computer-delivered VC-CBT to an intensity-matched computer-delivered active control intervention that focuses on healthy lifestyles. 256 individuals in residential AUD treatment who have a comorbid anxiety disorder will receive either the VC-CBT or the active control intervention to obtain 200 cases that complete a 1-, 4- and 8-month follow-up. The investigators predict the VC-CBT group will demonstrate superior alcohol-related outcomes at follow-up relative to the control group. Aim II evaluates the extent to which the computer-delivered VC-CBT selectively imparts the skills targeted and whether they convey (mediate) the interventions therapeutic effect. This entails a formal series of "causal steps" analyses of the associations of: treatment->skills; skills->outcomes; and, treatment -> outcomes, with vs. without the effect of skills->outcomes statistically controlled. Aim III will test the theoretically-derived prediction that the computer-delivered VC-CBT moderates (i.e., weakens) the association of near real-time negative affect and negative situations with drinking behavior and drinking urges. This will be accomplished by analyzing a series of electronic Ecological Momentary Assessment (EMA) recordings completed in participants' natural environment in each of the 30 days following the conclusion of treatment. The impact of this work would be to provide a scalable and inexpensive means of improving the otherwise poor AUD treatment outcomes of comorbid AUD treatment patients. The work will also provide new scientific knowledge about the mechanisms and processes of change stemming from comorbidity treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will not know which study group participants have been assigned to.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •current (past 30 days) Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of panic disorder with or without agoraphobia (PD/Ag), generalized anxiety disorder (GAD) or social anxiety disorder (SAD)
  • •receiving treatment primarily for alcohol (vs. drug) dependence
  • •ability to provide informed consent
  • •a minimum of an eighth grade English reading level
  • •status as a residential patient in the Lodging Plus (LP) addiction treatment program
  • •sufficient time left in their residential LP care to complete the study protocol through the post-treatment assessment

排除标准

  • •cognitive or medical impairments that prohibit study participation as determined by study PI
  • •serious suicide risk determined by study PI
  • •court-ordered treatment. (The exclusion is based on its classification as a "vulnerable" population.)
  • •Self-reported past participation in a Kushner intervention study while in Lodging Plus

研究组 & 干预措施

Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity

Experimental

Four, approximately 60 minute each, computerized therapy sessions delivered on an interactive computerized platform. All participants are undergoing a standard 28 day residential alcohol treatment program.

干预措施: Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy (Behavioral)

Control: Progressive Muscle Relaxation Training (PMRT)

Active Comparator

Four, one-hour computerized segments delivered on an interactive computerized platform teaching Progressive Muscle Relaxation Training (PMRT). All participants are undergoing a standard 28 day residential alcohol treatment program.

干预措施: Progressive Muscle Relaxation Training (PMRT) (Behavioral)

Treatment as Usual (TAU)

No Intervention

Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.

结局指标

主要结局

Percent heavy ("binge") days drinking

时间窗: eight-months following treatment (four-month assessment is primary)

a ratio expressed as a percent of the days the individual drank 5 (for men) or 4 (for women) or more drinks to the total number of days over the follow-up period in which drinking was possible.

Days to first use

时间窗: eight-months following treatment (four-month assessment is primary)

Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.

次要结局

  • Percent days drinking(eight-months following treatment (four-month assessment is primary))
  • Any use of alcohol(eight-months following treatment (four-month assessment is primary))
  • Days to first 3 consecutive days of drinking(eight-months following treatment (four-month assessment is primary))
  • Days to first binge(eight-months following treatment (four-month assessment is primary))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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