رادار التجارب AI | ||
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حالة التجربة السريرية NCT06127342 لـ PTSD هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Exercise and Emotional Learning in Posttraumatic Stress Disorder
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06127342 هي دراسة تدخُّلية لـPTSD وهي قيد التجنيد. بدأت في ٥ ذو القعدة ١٤٤٥ هـ مع خطة لتجنيد ١٠٠ مشاركًا. يقودها Christal L Badour، ومن المتوقع اكتمالها بحلول ٢٠ جمادى الآخرة ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١١ ربيع الأول ١٤٤٧ هـ.
الملخص
The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.
وصف مفصل
The proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for PTSD. Adults with PTSD related to interpersonal violence (IPV) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an MRI setting. This would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.
العنوان الرسمي
Exercise and Emotional Learning in Posttraumatic Stress Disorder
الحالات الطبية
PTSDمعرّفات دراسة أخرى
NCT معرّف
تاريخ البدء (فعلي)
2024-05-13
آخر تحديث مُنشور
2025-09-03
تاريخ الاكتمال (المقدر)
2026-11-30
عدد المشاركين المخطط لهم
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نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
Interpersonal Violence
Exercise
Exercise
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةModerate Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Moderate-Intensity Exercise (30-min at 70-75% max HR with 5-min warm-up and 5-min cool-down at 40-50% max HR), on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | تمرين متوسط الشدة Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes. |
مقارن نشطLow Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Low-Intensity Exercise (control; 40-mins at 40-50% max HR),on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Low Intensity Exercise Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. |
النتيجة الرئيسية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in participant subjective emotional ratings | Participant anxiety will be measured at baseline and after each imagery trial using a 10-point Likert-type scale with higher scores indicative of more subjective anxiety. | 24 hours |
Change in Heart Rate | Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system | 24 hours |
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response | Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial | 48 hours |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Adults with PTSD related to interpersonal violence
- Active or recent (within the last 3 months) severe substance use disorder(s)
- Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
- Significant developmental disabilities
- Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
- Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
- Medical condition(s) that prohibit exercise
- History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
- Magnetic resonance imaging (MRI) contraindication(s)
- Positive pregnancy test
- History of seizure disorder
- Spontaneous seizure(s) within the last 3 months
Christal L Badour- University of Texas at Austin
- National Institute of Mental Health (NIMH)
الجهة المسؤولة عن الدراسة
Christal L Badour, الراعي-المحقق, Associate Professor, University of Kentucky
جهة اتصال مركزية للدراسة
جهة اتصال: Christal G Badour, PhD, 859-323-3817, [email protected]
2 مواقع الدراسة في 1 بلدان
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Thomas G Adams, PhD, جهة اتصال, [email protected]
قيد التجنيد
Texas
University of Texas, Austin, Texas, 78712, United States
Josh Cisler, PhD, جهة اتصال, 512-495-5162, [email protected]
قيد التجنيد