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Table 5 Study assessments timeline

From: Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial

 

SC

Double-Blind Treatment Phase

Post

FU

FU

Week

0

1

2

3

4

5

6

7

8

EOT

12

16

Administrative Forms

            

Informed Consent

            

Inclusion/Exclusion Review

X

           

Locator Form and Updates*

X

X

X

X

X

X

X

X

X

X

X

 

Daily TMS Treatment Log

 

X

X

X

X

X

X

X

X

   

End of Treatment Form

         

X

  

Study Completion

           

X

General Assessments

            

Phen-X Toolkit Core Tier 1

X

           

Phen-X Toolkit Quality of Life

X

        

X

X

X

Study Demographics Form*

X

           

Treatment/Study Satisfaction Form

         

X

 

X

Medical Assessments

            

Physical Exam

X

           

Medical and Psychiatric History

X

           

Weight, Blood Pressure, and Pulse

X

X

   

X

   

X

X

X

Adverse Events, Serious Adverse Events, and Medical Review

X

X

X

X

X

X

X

X

X

X

X

X

Prior/Concomitant Meds

X

X

X

X

X

X

X

X

X

X

X

X

Penetration of Blind Assessment

     

X

   

X

 

X

EEG

X

   

X

       

Psychological Assessments

            

MINI 7.0.2*

X

           

HADS

X

   

X

   

X

X

X

X

Pittsburgh Sleep Quality Index

X

   

X

   

X

 

X

X

CHRT-SR Suicidal Behavior Eval

X

X

X

X

X

X

X

X

X

X

X

X

Substance Use Self Report

            

TLFB/Substance Use Diary

X

X

X

X

X

X

X

X

X

X

X

X

Caffeine Consumption Assessment

X

X

X

X

X

X

X

X

X

   

DSM-5 SUD Symptom Checklist*

X

           

NIDA Marijuana Use Assessment

X

           

Fagerström Test for Nicotine Dependence

X

   

X

    

X

X

X

Daily Assessments

            

Visual Analog Craving Scale

X

X

X

X

X

X

X

X

X

X

X

X

Report of Methamphetamine and/or Cocaine Use

X

X

X

X

X

X

X

X

X

X

X

X

Report of Nicotine Use

X

X

X

X

X

X

X

X

X

X

X

X

Mood

X

X

X

X

X

X

X

X

X

X

X

X

Sleep

X

X

X

X

X

X

X

X

X

X

X

X

Actigraphy

X

X

X

X

X

X

X

X

X

   

Lab Testing

            

UDS (dipstick)*

X

X

X

X

X

X

X

X

X

X

X

X

Urine Pregnancy Test*

X

   

X

   

X

   
  1. * During screening visit, it is recommended to start with these assessments after consent is obtained to minimize the workload for screen failures.
  2. Abbreviations used: SC: Screening; EOT: End of treatment; FU: Follow up; TMS: Transcranial magnetic stimulation; Phen-X: Phenotypes and Exposures; EEG: Electroencephalogram; MINI 7.0.2: Mini International Neuropsychiatric Interview Plus; HADS: Hospital Anxiety and Depression Scale; CHRT-SR: Concise Health Risk Tracking—Self Report; TLFB: Timeline Follow-Back; DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; SUD: Substance use disorder; NIDA: National Institute on Drug Abuse; UDS: Urine drug screen.