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临床试验/NCT04553120
NCT04553120已完成不适用

Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia: A Multiple-baseline Single Case Study

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4
试验地点
2
主要终点
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)

研究概览

简要总结

The aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the augmented reality (AR) exposure therapy using multiple stimuli versus one single stimulus through projection-based AR (P-ARET) for the treatment of participants diagnosed with cockroach phobia.

详细描述

Specific phobia (SP) refers to an extreme and persistent fear of a specific object or situation that is out of proportion to the actual danger or threat. SP is the most prevalent anxiety disorder with substantial impairment and comorbidity. Animal fear is one of the most prevalent subtypes of SP. In vivo exposure is the treatment of choice for this problem, but this technique is associated to limitations in its implementation related to the access and acceptability (i.e., low acceptance on the part of patients and therapists, high dropout rates, limited access to the treatment and, difficulties in its application in the clinical context). Augmented Reality (AR) offers some advantages in delivering the exposure technique: 1) Exposure to multiple virtual stimuli; 2) Going beyond reality; 3) Allowing complete control over the situation; 4) It allows privacy and confidentiality. Particularly, the most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world.

The study will follow the guidelines of a multiple-baseline single case design with alternating treatments. Participants (N = 4) who received a diagnosis of SP for cockroaches (DSM-5), will be randomly assigned to different baselines (ranging between 8 and 14 days) and all of them will receive the two experimental conditions: 1) AR exposure therapy with multiple stimuli and; 2) AR exposure therapy with a single stimulus. Five evaluation moments will be included: pre-intervention (baseline), post- intervention, and follow-up at the first month, 6 and 12 months.

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
None

入排标准

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

入选标准

  • Being at least 18 years old
  • Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches
  • Having a minimum of six-month duration of the phobia
  • Sign an informed consent
  • Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied

排除标准

  • Presence of another severe mental disorder that requires immediate attention
  • Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
  • Currently being treated in a similar treatment program
  • Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
  • Receiving other psychological treatment during the study for cockroach phobia
  • Start receiving pharmacological treatment during the study (or in case of being already taking them, change the drug or dose)

结局指标

主要结局

Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)

时间窗: At the beginning of the intervention and immediately after the treatment

Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).

Change in fear, avoidance, belief in negative thoughts and coping ability with the feared stimulus levels.

时间窗: Once a day (from the start of the baseline until the end of the treatment) and at 1, 6 and 12 months after the end of the treatment.

Item1: If you see a cockroach in front of you at this moment… To what extent would you be scared of it? Item 2: If you see a cockroach in front of you at this moment… to what extent would you avoid it?, Item 3: If you see a cockroach in front of you at this moment… To what extent would you believe that it is dangerous for you?, Item 4: To what extent you believe that you could cope with a cockroach of different size, colour and shape? Ranged from 0 (nothing) to 10 (very much)

次要结局

  • Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)(At the beginning of the intervention and immediately after the treatment)
  • Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)(At the beginning of the intervention and immediately after the treatment)
  • Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).(At the beginning of the intervention and immediately after the treatment)
  • Preferences(Immediately after the treatment)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

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