Pilot Study: VR Mind and VR Mind+ Intervention
Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be:
- the length of the laboratory session utilizing virtual reality exposure (feasibility),
- the ergonomics and ease of use for both patients and system operators (usability),
- the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).
The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Mazowieckie
-
Warszawa、Mazowieckie、ポーランド、02-957
- Instytut Psychiatrii i Neurologii
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age: 18-50 y.o.
- Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- Signing informed consent
Exclusion Criteria:
- Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
Occurrence and/or recognition:
- psychosis,
- bipolar disorder,
- mental retardation
Exclusion based on interview:
- pregnancy,
- drug addiction,
- alcohol addiction,
- participating in the experimental session while intoxicated
- (current) neurological treatment of chronic disease of central nervous system,
- epilepsy,
- paroxysmal vertigo,
- presence of suicidal thoughts , tendencies or attempts,
- participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：VR Mind
Two VR Mind sessions using experimental virtual reality scenarios.
During these two sessions, participants will be exposed to virtual reality environment, for 2 x 10 min each session.
|
Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety.
The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public".
Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
時間枠：At the end of 4th laboratory session within 2 weeks
|
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
|
At the end of 4th laboratory session within 2 weeks
|
|
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
時間枠：At the end of 2nd and 3th laboratory session within 2 weeks
|
Number of virtual reality exposure sessions completed in predefined time.
|
At the end of 2nd and 3th laboratory session within 2 weeks
|
|
Usability_ 3: immersion, perceived reality and engagement
時間枠：At the end of 2 and 3 laboratory session within 2 weeks
|
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree":
|
At the end of 2 and 3 laboratory session within 2 weeks
|
|
Safety_1: occurrence and severity of simulator sickness
時間枠：During 2nd and 3th laboratory session within 2 weeks
|
Simulator sickness is expected adverse effect of the VR. Hence, the Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) will be administered as a primary outcome measure to evaluate safety of the VR intervention. Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as:
|
During 2nd and 3th laboratory session within 2 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Global Impression
時間枠：During 1st and 4th session within 2 weeks
|
Clinical Global Impression (Guy, 1976) - is a single item, 7 point scale used by clinicians to asses the severity of illness, where 1 is labeled as "Normal, not at all ill" and 7 is labeled as "Among the most extremely ill patients".
|
During 1st and 4th session within 2 weeks
|
|
Patient Global Impression
時間枠：During 1st and 4th session within 2 weeks
|
Patient Global Impression - is a single item, 4 point scale used by patients to asses their impression of severity of their illness and quality of their functioning in everyday life, where 1 is labeled as "Normal" and 4 is labeled as "Severe".
|
During 1st and 4th session within 2 weeks
|
|
Liebowitz Social Anxiety Scale
時間枠：During 1st and 4th session within 2 weeks
|
Liebowitz Social Anxiety Scale (LSAS; Leibowitz, 1987) The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144). |
During 1st and 4th session within 2 weeks
|
|
Beck Depression Inventory
時間枠：During 1st and 4th session within 2 weeks
|
During 1st and 4th session within 2 weeks
|
|
|
Subjective Units of Distress
時間枠：During 2nd and 3th session within 2 weeks
|
Subjective Units of Distress (SUD) SUD is a subjective measure of perceived fear in certain situation. The scale range is from 0 ("Totally relaxed) to 100 ("Highest distress/fear/anxiety/discomfort that you have ever felt"). |
During 2nd and 3th session within 2 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Paweł Mierzejewski, prof、Tomorrow Sp. z o.o.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
VR Mindの臨床試験
-
Tomorrow Sp. z o.o.National Center for Research and Development, Poland完了
-
University of Kansas Medical Center積極的、募集していない
-
Johns Hopkins UniversityCenters for Medicare and Medicaid Services; Jewish Community Services; Johns Hopkins Home Care...完了
-
Universiteit AntwerpenArtesis University College, Antwerp; Rehabilitation Hospital Hof Ter Scheldeわからない
-
University of SkövdeAlbert Einstein College of Medicine; Uppsala University; Göteborg University; University of Pavia; State University of New York - Downstate Medical Center と他の協力者まだ募集していません
-
University of Illinois at Urbana-ChampaignUniversity of Illinois at Chicago; National Institute on Aging (NIA)募集
-
Practitioners Alliance Network完了