A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
2026년 4월 23일 업데이트: University of South Florida
Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II
The goal of this clinical trial is to learn if a telemedicine-based virtual reality clinic (Doxy.me VR) works to treat dog, spider, and snake phobias in adults. The main questions it aims to answer are:
Does Doxy.me VR decrease the severity of phobias better than traditional telemedicine-based treatment? Does this work because it feels more realistic than telemedicine alone?
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
240
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Maureen Jacobs Plaisimond
- 전화번호: 813-396-0060
- 이메일: MCOM-VRStudy@usf.edu
연구 장소
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Florida
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Tampa, Florida, 미국, 33613
- University of South Florida
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연락하다:
- Maureen Jacobs Plaisimond
- 전화번호: 813-396-0060
- 이메일: MCOM-VRStudy@usf.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
Individuals will be eligible if they: (1) are an adult (≥18 years old); (2) have a self-reported fear of dogs, snakes, and/or spiders; (3) score 89 ≥ on the FSQ OR 24 ≥ on the SNAQ OR 147 ≥ on the DPQ; and (4) have access to the internet AND a computer OR smartphone with video conferencing capabilities.
Exclusion Criteria:
Individuals will be ineligible to participate if they: (1) are participating in ongoing mental health therapy from a non-study therapist; (2) changed psychiatric medication use within the past 6 weeks; (3) report active auditory, visual, and/or tactile hallucinations via the DART Psychosis Module screening question; (4) report active health conditions requiring upcoming planned or likely hospitalization or intensive treatment that will prevent them from participating; (5) report active legal proceedings that might lead to incarceration during the study period that would prevent them from participating; (6) report an unstable housing situation (eg., eviction or homelessness); (7) have experienced photosensitive seizures within the prior 6 months; (8) endorse more than 20% of symptom validity questions.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Telemedicine-based Virtual Reality Exposure Therapy
This group will receive exposure therapy in a telemedicine-based Virtual Reality Clinic using virtual reality snakes, dogs, or spiders.
The VR stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.
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Participants will complete 7 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures. Other Name: |
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활성 비교기: Standard Telemedicine-Based Exposure Therapy
This group will receive exposure therapy via Doxy.me
telemedicine platform using photos and videos of snakes, dogs, or spiders.
The photo/video stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.
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Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Phobia symptom severity
기간: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Severity Measure for Specific Phobia (SMSP) is a 10-item self-report questionnaire that assesses the severity of specific phobia symptoms relative to an individual's feared stimulus.
Total scores range from 0 to 4 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Dog Phobia Severity
기간: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Dog Phobia Questionnaire (DPQ) is a 27-item, self-report questionnaire assessing the severity of dog phobia symptoms.
Scores range from 27 to 189 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Snake Phobia Severity
기간: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Snake Anxiety Questionnaire (SNAQ) is a 30-item self-report questionnaire assessing the severity of snake phobia symptoms.
Scores range from 0 to 30 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Spider Phobia Severity
기간: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Fear of Spiders Questionnaire (FSQ) is an 18-item self-report questionnaire assessing the severity of spider phobia symptoms.
Scores range from 18 to 126 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Specific Phobia Diagnosis
기간: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Diagnostic Assessment Research Tool (DART) is a modular semi structured interview corresponding with the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
Study therapists administer the DART Specific Phobia Module, which provides designations of Absent, Subthreshold, and Present.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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General Anxiety
기간: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptom severity.
Scores range from 0 to 15 with higher scores indicating higher anxiety severity.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Depression Severity
기간: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure of depression symptom severity.
Scores range from 0 to 27 with higher scores indicating higher depression severity.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Quality of Life Level
기간: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Quality of Life Scale (QOLS) is a 16-item self-report measure of quality of life.
Scores range from 16 to 112 with higher scores indicating better quality of life.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Level of Telepresence
기간: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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The iGroup Presence Questionnaire (iPQ) is a 14-item self-report questionnaire of telepresence.
Scores on each subscale range from 0-6 with higher scores indicating more presence.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Cybersickness Severity
기간: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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The Cybersickness in Virtual Reality Questionnaire (CSQ-VR) is an 6-item measure of nausea, vestibular, and oculomotor cybersickness experienced in virtual reality.
Scores range from 6 to 27 with higher scores indicating higher levels of cybersickness.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Level of Working (Therapeutic) Alliance
기간: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The Working Alliance Inventory (WAI-SR) is a 12-item client-rated measure of therapeutic alliance.
Total scores range from 1 to 5 with higher scores indicating a better therapeutic alliance.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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Satisfaction with Therapy
기간: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) is a 13-item self-report questionnaire that assesses client satisfaction with treatment.
Scores range from 0 to 60 with higher scores indicating higher satisfaction.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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System Usability
기간: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The System Usability Scale (SUS) is a 10-item self-report measure of the usability of a particular software system, platform, or app.
Scores range from 0-100 with higher scores indicating better usability.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Brian E. Bunnell, PhD, University of South Florida
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 4월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2028년 1월 1일
연구 등록 날짜
최초 제출
2026년 4월 23일
QC 기준을 충족하는 최초 제출
2026년 4월 23일
처음 게시됨 (실제)
2026년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 4월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 23일
마지막으로 확인됨
2026년 2월 1일
추가 정보
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