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Table 1 SPIRIT chart. CAPS-5 is the Clinician-Administered PTSD Scale-5; SCID is the Structured Clinical Interview for Diagnosis; DES-II is the Dissociative Experiences Scale; DRRI is the Deployment Risk and Resilience Inventory-2; CES is the Combat Exposure Scale; LEC is the Life Experiences Checklist; ACE is the Adverse Childhood Experience Questionnaire; MoCA is the Montreal Cognitive Assessment; PCL-5 is the PTSD Checklist-Military-5; PPR is Psychophysiological Response; BDI-II is the Beck Depression Inventory – II; HAM-A is the Hamilton Anxiety Rating Scale; NMCL-SOM is the New Mexico Symptom Checklist – Somatic Scale; The PSQI is the Pittsburg Sleep Quality Index; VR-12 is the Veterans RAND 12-item Health Survey; EDS is the Emotion Dysregulation Scale; McGill is the McGill Pain Questionnaire; Southampton is the Southampton Needle Sensation Questionnaire; AQ is the Aggression Questionnaire; CRS is the Credibility Rating Scale

From: Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

STUDY PERIOD

 

Enrollment

Allocation and Baseline

Treatment

Follow-up

Timepoint

Week -4 to -1

Week -4 to 0

Week 0

Week 6

Week 12

Week 16

Screening, Enrollment, Allocation and Baseline Data

 Screening for Eligibility

X

     

 Informed Consent

X

     

 Inclusion and Exclusion

      

 CAPS-5 [16]

X

    

 SCID [17]

X

     

 DES-II [18]

X

     

 DRRI [19]

X

     

 CES [20]

X

     

 Narrative-Exposure, Effects on Health and with Treatment (unpublished)

 

X

  

X

 

 LEC [21]

X

     

 ACE [22]

 

X

    

 MoCA [23]

X

     

 Allocation

 

X

    

Interventions

 Verum Acupuncture

    

 Sham Acupuncture

    

Assessments: Primary Outcomes

 CAPS-5 Severity Score [16]

 

X

 

X

X

X

 PCL-5 [24]

 

X

 

X

X

X

Assessments: Secondary Outcome

 PPR (startle response)

 

X

 

X

X

X

Assessments: Exploratory

 BDI – II [25]

 

X

 

X

X

X

 HAM-A [26]

 

X

 

X

X

X

 NMCL – SOM [27]

 

X

 

X

X

X

 PSQI [28]

 

X

 

X

X

X

 VR-12 [29]

 

X

 

X

X

X

 EDS [30]

 

X

 

X

X

X

 McGill [31]

 

X

 

X

X

 

 Southampton [32]

  

Bi-weekly

 

 PPR (HR, HRV, SCR)

 

X

 

X

X

X

Assessments: Safety and Control

 AQ [33].

  

Weekly

X

X

 BDI – II items 9, 11, 17

  

Weekly

X

X

 Satisfaction with Care and Provider Scale (Unpublished)

    

X

X

 Intercurrent Health Resource Use Inventory (unpublished)

 

X

  

X

X

Assessments: Fidelity and Credibility

 Treatment Fidelity Assessment (Unpublished)

 

selected

    

 CRS [34]

 

selected

session 2

session 24

  
  1. CAPS-5 is the Clinician Administered PTSD Scale-5; SCID is the Structured Clinical Interview for Diagnosis; DES-II is the Dissociative Experiences Scale; DRRI is the Deployment Risk and Resilience Inventory-2; CES is the Combat Exposure Scale; LEC is the Life Experiences Checklist; ACE is the Adverse Childhood Experience Questionnaire; MoCA is the Montreal Cognitive Assessment; PCL-5 is the PTSD Checklist-Military-5; PPR is Psychophysiological Response; BDI-II is the Beck Depression Inventory – II; HAM-A is the Hamilton Anxiety Rating Scale; NMCL-SOM is the New Mexico Symptom Checklist – Somatic Scale; The PSQI is the Pittsburg Sleep Quality Index; VR-12 is the Veterans RAND 12-item Health Survey; EDS is the Emotion Dysregulation Scale; McGill is the McGill Pain Questionnaire; Southampton is the Southampton Needle Sensation Questionnaire; AQ is the Aggression Questionnaire; CRS is The Credibility Rating Scale
  2. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207.
  3. Dai L, Cheng CW, Tian R, Zhong LL, Li YP, Lyu AP, Chan AW, Shang HC, Bian ZX. Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2019;25(1):71-79. PMID: 30484022
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