Skip to main content

Table 2 Primary and secondary outcomes according to time-point

From: A multi-centre, double-blind, 12-week, randomized, placebo-controlled trial to assess the efficacy of adjunctive N-Acetylcysteine for treatment-resistant PTSD: a study protocol

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    
  1. Indicates clinical interview