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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