An Internet-based Treatment for Flying Phobia Using 360º Images: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Qualitative Interview
研究概览
简要总结
Flying phobia (FP) is one of the most prevalent phobias in our society. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or have problems accessing these therapies.
The aim of the present study is to conduct a feasibility pilot with NO-FEAR Airlines ICBT (Campos et al., 2016) using two types of images in the exposure scenarios (still images vs 360º navigable images). A secondary aim is to explore the potential effectiveness of the two active treatment arms compared to a waiting list control group. Finally, we will explore the role of navigable images compared to the still images in the level of anxiety, sense of presence, and reality judgment in the exposure scenarios and whether the aforementioned variables mediate in treatment efficacy.
Regarding the main aim of this study, we hypothesize that both treatment conditions will be well accepted by the participants, but participants will prefer 360º images over still images.
详细描述
Flying phobia (FP) is one of the most prevalent phobias in our society. Around 25% of the population that flies experiences intense distress during the flight; around 10% of the general population does not fly due to intense fear and 20% of people depend on alcohol or tranquilizers to overcome the fear of flying.
In vivo exposure is the most effective psychological treatment for specific phobias. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or they have problems to access these therapies.
Information and Communication Technologies (ICTs) can improve treatment adherence and acceptance. Particularly, computerized programs offer remarkable advantages such as a reduction in direct therapeutic contact time, the possibility of standardizing treatment as much as possible with a steep exposure gradient, the low cost and, maybe most importantly, access to patients who would not be very willing to subject themselves to in vivo exposure. The application of cognitive-behavioural procedures such as exposure through interactive computer programs is especially recommended.
On the other hand, it is important to explore the role of the degree of immersion and sense of presence in the psychological treatments with iCBTs due to the contradictory conclusions that had been found in the literature. Therefore, it is expected that the present work advances in the knowledge in this field exploring these factors in an Internet-based self-applied treatment program for FP evaluating if a change in the exposure images used in the program NO-FEAR Airlines (Campos et al., 2016) will be feasible in a future RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Be between 18-65 years of age
- •To meet current DSM-5 criteria for specific phobia (flying phobia).
- •Be willing to participate in the study.
- •Be able to use a computer and having an Internet connection.
- •Be able to understand and read Spanish.
- •Have an e-mail address.
排除标准
- •Be receiving psychological treatment for fear of flying.
- •A severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia, bipolar disorder.
- •Severe Personality Disorder.
- •Presence of depressive symptomatology, suicidal ideation or plan.
- •Presence of heart disease.
- •Pregnant women (from the fourth month).
结局指标
主要结局
Qualitative Interview
时间窗: Up to 12 months
This interview assesses the participant's opinion of the intervention program after finishing it. The interview contains 13 items that the patient has to rate on a scale ranging from 1 ("very little") to 5 ("very much") and explain the reasons for their rating on each question. There are also two open questions where the participants have to give their overall opinion about the intervention program and the program images. In this interview, the perceived sense of presence and reality judgement in each scenario will also be assessed.
Preferences questionnaire
时间窗: Up to 12 months
This questionnaire collects the patient's preferences regarding the two types of images included in this study (navigable and still images) through 5 dichotomous questions where they have to choose one of the two conditions. Participants will answer these questions before the treatment and before knowing the condition to which they are allocated (after the characteristics of each type of image are explained) and after they have completed the treatment (and after seeing a short video showing the image condition they did not receive).
Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972)
时间窗: Up to 12 months
This self-report inventory measures the patients' expectations before they start the treatment and after they receive a brief explanation about the intervention and their experimental condition. The same questions have to be answered when the patient completes the treatment in order to assess satisfaction. The 6 items are rated from 1 ("Not at all") to 10 ("Highly").
次要结局
- The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).(Up to 12 months)
- Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).(Up to 12 months)
- Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)(Up to 12 months)
- Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)(Up to 12 months)
- Fear of Flying Scale (FFS; Haug et al., 1987).(Up to 12 months)