Outcome | Measure | Trial | Post-trial | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | W 1–3 | W 4 | W 5–7 | W 8 | W 9–11 | W 12 | W 13–15 | W 16 | W 64 | ||
Primary Outcome | |||||||||||
Trauma history, PTSD diagnosis and symptom severity | CAPS-5 (monthly version; 30-item observer rated questionnaire, corresponding to the DSM-5 diagnosis for PTSD) [30] | X | X | X | X | ||||||
PTSD symptom severity | CAPS-5 (weekly version) | X | X | X | X | X | |||||
Secondary Outcomes | |||||||||||
Depression & Anxiety | HADS (14 item self-report screening measure of anxiety and depression, designed for use in medical settings) [31] | X | X | X | X | X | X | ||||
HAM-D (17 item observer rated scale; evaluates core symptoms of depression) [32] | |||||||||||
Self-rated PTSD symptoms | PCL-5 (20 item self-report measure of PTSD symptoms) [33] | X | X | X | X | X | X | X | X | X | X |
Somatic symptoms | PHQ-15 (15 item self-report measure of degree to which one has been bothered by somatic symptoms over the past month) [34] | X | X | X | X | X | X | ||||
Quality of life | WHO-QOL BREV (26 item measure of subjective quality of life) [35] | X | X | X | X | X | X | ||||
Alcohol use | AUDIT (Participant answer ten-items relating to frequency of symptoms and behaviours associated with alcohol misuse) [36] | X | X | X | X | X | X | ||||
Substance craving | Visual Analogue Scale (to assess substance craving over the past week. Participants will rate 5 items using anchors of 0 (“not at all”) to 10 (“extreme” or “all the time”) | X | X | X | X | X | X | ||||
Biomarkers of oxidative stress | Optional blood analysis (IL-6, TNF-alpha, TBARS, MDA, BDNF) | X | X | ||||||||
Other Measures | |||||||||||
Other psychiatric comorbidities | MINI V 5.0 (Semi-structured interview to assess habitual substance use and psychiatric comorbidities, including psychotic disorders) [37] | X | |||||||||
Demographic Information | Questionnaire | X | |||||||||
Adverse effects | Self-report | X | X | X |