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Table 2 Assessments in the Effects of PHysical Activity in PSychosis (EPHAPS) trial

From: Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial

 

Enrollment

Baseline

Randomization

Follow-up 1

Follow-up 2

TIME POINT

 

T0

0

T1 12 weeks

T2 28 weeks

ENROLLMENT

     

Eligibility screen

X

    

Informed consent

X

    

Allocation

  

X

  

INTERVENTIONS

     

Exercise Group (EG)

  

>---------------<

 

Computer Gaming Skills Group (CSG)

  

>---------------<

 

ASSESSMENTS

General assessments

Sociodemographic data

 

X

   

Changes in employment status

   

X

X

Information on tobacco, dietary habits and current level of physical activity

 

X

   

Changes in use of tobacco, dietary habits, medication

   

X

X

Somatic health

Physical examination: height; electrocardiography (ECG); medication record

 

X

   

Weight, waist circumference, blood pressure

 

X

 

X

X

Changes in medication

   

X

X

Body composition assessment (bioelectrical impedance analysis/Tanita-weight)

 

X

 

X

X

Blood analyses: glucose, HbA1c, C-peptide, lipids (total cholesterol, HDL, LDL, TGA), homocystein, prolactin, T4, TSH, BDNF

 

X

 

X

X

Spirometry (pulmonary function test)

 

X

 

X

X

Cardiorespiratory fitness, physical activity and sleeping habits

Maximal oxygen consumption

 

X

 

X

X

ActiGraph accelerometers (4 days)

 

X

 

X

X

Attitudes towards physical activity (PA)

 

X

   

Change in attitudes towards PA (two selected items from Attitudes towards PA)

   

X

X

International Physical Activity Questionnaire (IPAQ)

 

X

 

X

X

Assessment of insomnia: Insomnia Severity Index (ISI)

 

X

 

X

X

Psychoactive substance use

Selected parts of European Addiction Severity Index (EuropASI)

 

X

 

X

X

SCID section E

 

X

   

Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)

 

X

   

Alcohol and Drug Use Scale (AUS and DUS)

 

X

 

X

X

Fagerström test for Nicotine Dependence (FTND)

 

X

 

X

X

Saliva samples for assessing recent intake of tobacco, alcohol, illegal drugs and legal medication with abuse potential

 

X

 

X

X

Neurocognitive tests

General Ability Index (GAI, Wechsler Adult Intelligence Scale-version 4)

 

X

 

X

X

The Emotional Biological Motion Test

 

X

 

X

X

Matrics Consensus Cognitive Battery (MCCB)

 

X

 

X

X

Diagnostics/symptoms/wellbeing

The Structural Clinical Interview DSM-IV for axis I disorders (SCID-I)

 

X

   

The Positive and Negative Syndrome Scale (PANSS)

 

X

 

X

X

The Psychotic Symptom Rating Scale (PSYRATS)

 

X

 

X

X

The revised Beliefs About Voices Questionnaire (BAVQ)

 

X

   

Positive and Negative Affects Schedule (PANAS)

 

X

 

X

X

Depression: Calgary Depression Scale for Schizophrenia (CDSS)

 

X

 

X

X

WHO-5 Well-Being Index

 

X

 

X

X

Self-esteem (Ad Morrison)

     

Clinical Global Impression Scale (CGI)

 

X

 

X

X

Psychosocial functioning

Global Assessment of Functioning (GAFs and GAFf)

 

X

 

X

X

Quality of Life (Strauss Carpenter Level of Function (SCLOF))

 

X

 

X

X

Insight/adherence/apathy

Insight of illness: Birchwood Insight Scale; cognitive insight: Beck Cognitive Insight Scale

 

X

 

X

X

Adherence to treatment: The Believes about Medicines Questionnaire (BMQ)

 

X

 

X

X

Apathy: Apathy Evaluation Scale (AES)

 

X

 

X

X

  1. The table depicts specific time points in the trial for enrolment, intervention (groups and duration), and the assessments
  2. BDNF brain-derived neurotropic factor, HbA1c glycosylated hemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein, T4 thyroxine, TGA triglycerides, TSH thyroid stimulating hormone