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Table 1 Events and time table

From: Effect of running therapy on depression (EFFORT-D). Design of a randomised controlled trial in adult patients [ISRCTN 1894]

     

Intervention period

Follow-up period

Procedure

Source

Person

No. of items

Duration (min.)

T0

T3

T6

T12

   Written informed consent

letter

patient

  

X

   

   Demographics1

patient file

research assistant

  

X

   

Depression

        

   Depression history2

patient file

research assistant

2

 

X

   

   HRSD3

interview

blind rater

17

20

X

X

X

X

   IDS-SR4

questionnaire

patient

30

10

X

X

X

X

   Bearableness (VAS)

questionnaire

patient

1

 

X

X

X

X

Metabolic syndrome

        

   Length

physical test

research assistant

 

1

X

   

   Weight

physical test

research assistant

 

1

X

X

X

X

   Waist circumference

physical test

research assistant

 

1

X

X

X

X

   Blood pressure

physical test

research assistant

 

1

X

X

X

X

   Smoking/alchohol intake

questionnaire

patient

 

1

X

X

X

X

   Laboratory assesment6

physical test

laboratory

 

2

X

X

X

X

Quality of Life

        

   WHO-DAS7

questionnaire

patient

36

 

X

X

X

X

Pain

        

   GCPS8

questionnaire

patient

7

 

X

X

X

X

   Bearableness (VAS)

questionnaire

patient

1

 

X

X

X

X

Anxiety

        

   BAI9

questionnaire

patient

21

 

X

X

X

X

Cost effectiveness

        

   TIC-P10

quest./pnt file

pnt/research assistant

 

26

X

 

X

X

   Euroqol

questionnaire

patient

 

5

X

 

X

X

   Subjective health (VAS)

questionnaire

patient

 

1

X

 

X

X

Fitness

        

   Submaximal cycle test

physical test

research assistant

 

10

X

X

X

X

   Grip strength

physical test

research assistant

 

2

X

X

X

X

   Exercise intensity (HR)11

physical test

exercise instructor

  

during training sessions

Personality

        

   NEO PI-R12

questionnaire

patient

60

 

X

   

Physical activity

        

   SQUASH13

questionnaire

patient

12

 

X

X

X

X

Additional Measures

        

   LEQ14

questionnaire

patient

12

 

X

X

X

X

   Compliance

registration

exercise instructor

  

during training sessions

   POMS15

questionnaire

patient

32

 

during training sessions

   Evaluation Intervention16

questionnaire

patient

    

X

 
  1. 1: Date of birth, sex, education, ethnicity, income, professional status, living situation, marital status
  2. 2: Number and duration of former episodes, duration current episode
  3. 3: Hamilton Rating Scale of Depression (or HAMD)
  4. 4: Inventory of Depressive Symptomatology - Self Report
  5. 6: fasting glucose, triglycerides, total cholesterol, HDL- cholesterol, cholesterol/HDL-ratio, creatinine, MDRD
  6. 7: World Health Organisation- Disability Assessment Schedule
  7. 8: Graded Chronic Pain Scale
  8. 9: Beck Anxiety Inventory
  9. 10: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness
  10. 11: Polar RS 800 CX Run
  11. 12: Revised NEO Personality Inventory
  12. 13: Short QUestionnaire to ASses Health enhancing physical activity
  13. 14: Life Events Questionnaire
  14. 15: Profile of Mood State
  15. 16: Only for patients who participated in the intervention
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