SHIELD – Swift Hydrocortisone Intervention after trauma exposure
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Posttraumatic Stress Disorder (PTSD)
Спонсор: Amsterdam UMC Stichting
Налично на:
БГ
Обобщение
Trial status: Authorised
Status of PTSD diagnosis at 3 months (T4) after the intervention, measured with the CAPS-5., Self-reported PTSD symptom severity at 2 weeks (T1), 1 month (T2), 6 weeks (T3), 3 months (T4), 6 months (T5) and 12 months (T6) after the intervention, measured with the PCL-5., Scores on the questionnaires assessing other outcomes (IDS-SR, EQ-5D-5L, AUDIT, ISI) and SAEs at T1 to T6., Demographic data, scores on questionnaires (CTQ, LEC-5), wearable measuring heart rate (HR) and heart rate variability (HRV), intrusion and sleep diary, saliva sample collected at intake, self-composed questionnaires., Results of qualitative interviews with 20 participants of the trial
PTSD symptom severity at 3 months (T4) after the intervention, measured with the CAPS-5 score.
Описание
Status of PTSD diagnosis at 3 months (T4) after the intervention, measured with the CAPS-5., Self-reported PTSD symptom severity at 2 weeks (T1), 1 month (T2), 6 weeks (T3), 3 months (T4), 6 months (T5) and 12 months (T6) after the intervention, measured with the PCL-5., Scores on the questionnaires assessing other outcomes (IDS-SR, EQ-5D-5L, AUDIT, ISI) and SAEs at T1 to T6., Demographic data, scores on questionnaires (CTQ, LEC-5), wearable measuring heart rate (HR) and heart rate variability (HRV), intrusion and sleep diary, saliva sample collected at intake, self-composed questionnaires., Results of qualitative interviews with 20 participants of the trial
Кой може да участва
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 196 participants
Интервенции
Placebo pills will be matched in appearance and over-encapsulated with the same capsule as the test medication.
БГ
EN