SHIELD – Swift Hydrocortisone Intervention after trauma exposure
Phase 2 – studying effectiveness and dosage
Conditions:
Posttraumatic Stress Disorder (PTSD)
Sponsor: Amsterdam UMC Stichting
trial.available_in:
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Overview
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.
Description
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
Who can participate
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 196 participants
Interventions
Placebo pills will be matched in appearance and over-encapsulated with the same capsule as the test medication.
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