Improving the Efficacy of Exposure Therapy Using Projection-Based Augmented Reality for the Treatment of Cockroach Phobia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 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 the Projection-Based augmented reality therapy under two conditions: multiple stimuli (different types of cockroaches) (P-ARET MS) versus single stimulus (one cockroach) (P-ARET SS) 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 presents 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.
We pretend to go a step beyond and explore ways of optimizing exposure therapy based on the inhibitory learning approach. AR can maximize some strategies like "variability" (varying stimuli, durations, levels of intensity, or the order of the hierarchy items), greater control by the therapists or "exposure to multiple contexts" which can produce a positive effect in terms of fear renewal and generalization of the results. Therefore, the aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the ARET: using multiple stimuli (MS) (P-ARET MS) versus single stimulus (SS) (P-ARET SS) in participants with cockroach phobia.
The Randomized Clinical Trial (RCT) will be conducted following the Consolidated Standards of Reporting Trials (CONSORT: http://www.consort-statement.org) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Participants (N = 80) who received a diagnosis of SP for cockroaches (DSM-5), will be randomized into two experimental conditions: 1) Projection-based augmented reality therapy (P-ARET) with Multiple Stimuli (MS) (P-ARET MS); 2) Projection-based augmented reality therapy (P-ARET) with Single Stimulus (SS) (P-ARET SS). Five evaluation moments will be included: pre-intervention, post- intervention, and 1-, 6- and 12-month follow-ups.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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: Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of 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 and evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).
次要结局
- Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995).(Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.)
- Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).(Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.)
- Change in Beck Depression Inventory 2nd edition (BDI-II; Beck, Steer, Brown, 1996; Spanish validation from Sanz, Navarro y Vázquez, 2003)(Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months))
- Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).(Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.)
- Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).(Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.)
- Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).(Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.)
- Change in State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner, & Spielberger, 1981)(Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).)