Emotional Processes During a Randomized Controlled Trial of Virtual Reality Exposure Treatment for Flight Phobia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Changes in FAS (Flight Anxiety Situations Questionnaire) Scores
研究概览
简要总结
This study will assess emotional processes and their relation to treatment outcomes during Virtual reality exposure therapy for Flight Phobia. The researchers hypothesize treatment outcomes will be associated with positive changes in emotional constructs
详细描述
Emotional constructs and emotion regulation capacities play a central role in the severity of anxiety disorders and are directly related to treatment outcomes in different anxiety disorders. In this study we will examine the relation between positive and negative affect, emotion regulation, emotional instability, emotional differentiation, experiential avoidance and therapy outcomes in participants undergoing Virtual Reality Exposure Therapy for Flight Phobia. We assume that treatment outcomes will be positively related to changes in the regulation, management and experience of emotions.
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
- 否
入选标准
- •diagnosis of Flight phobia based on a structured interview
- •possession of a smartphone with an active data plan
排除标准
- •cardiovascular disease
- •neurological disorders and history of epilepsy
- •psychosis
- •major depression
- •suicidal behavior
- •substance abuse.
研究组 & 干预措施
Virtual Reality Exposure Therapy (VRET)
- st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders.
- nd stage: During the week prior to treatment, participants will complete a brief measure of emotion-related variables every evening at a fixed time (08:00 pm).
- rd stage: Participants will receive therapy for fear of flying using a Virtual Reality (VR) simulator. Therapy sessions will be held once a week during 4 weeks. Participants will complete a brief measure of emotion-related variables at a random time during the 12 hours before the therapy session at a random time during the 12 hours after the therapy session. This will occur for every therapy session.
- th stage: After treatment, participants will complete measures of fear of flying and emotional variables.
干预措施: VRET - Virtual Reality Exposure Therapy (Behavioral)
control
- st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders.
- nd stage: During five weeks no therapy will be administered. Participants will fill questionnaires as follows: During the first week, participants will complete emotional measures every evening at a fixed time (08:00 pm)
- rd stage: During each of the following 4 weeks, participants will complete two emotional measures during a 24 hour period.
- th stage: Participants will complete measures of fear of flying and emotional variables.
结局指标
主要结局
Changes in FAS (Flight Anxiety Situations Questionnaire) Scores
时间窗: Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks)
The Flight Anxiety Situations Questionnaire (Van Grewen, Spinhoven, Van-Dyck, \& Dikstra, 1999) is a 32-item, 5-point Likert-scale (1= no anxiety to 5=overwhelming anxiety). The FAS evaluates flight-related anxiety in various situations. We used the total score of the FAS which ranges from 32 to 160 with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.
Changes in FAM (Flight Anxiety Modality Questionnaire) Scores
时间窗: Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks).
The Flight Anxiety Modality (FAM) questionnaire (Van Grewen et al. 1999) assesses somatic and cognitive aspects of Flight Phobia. It includes 18 items that are rated using a 5-point scale (1=not at all, 5=very intensely). We used the total score of the FAM which ranges from 18 to 90, with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.
次要结局
未报告次要终点
研究者
Idan Moshe Aderka
Ph.D. Senior Lecturer
University of Haifa