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Table 2 Timing of clinical assessments and measures throughout the study

From: Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial

Instruments/time point

Screen

Baseline

Tx-1

Post-1

Tx-2

Post-2

3-month FU

6-month FU

9-month FU

12-month FU

Medical history/physical exam

X

         

Mini-Mental State

X

         

Vital signs

X

  

X

 

X

X

X

X

X

Insomnia Interview Schedule

X

  

X

 

X

X

X

X

X

Duke Structured Interview for Sleep Disorders

X

  

X

 

X

X

X

X

X

Structured Clinical Interview for DSM-IV Disorders

X

      

X

 

X

Sleep diary

X

X

X

X

X

X

X

X

X

X

Polysomnography

X a

X a

 

X

 

X

    

Insomnia Severity Index

X

X

X

X

X

X

X

X

X

X

Clinical Global Improvement

   

X

 

X

X

X

X

X

Pittsburgh Sleep Quality Index

 

X

 

X

 

X

X

X

X

X

Dysfunctional Beliefs and Attitudes about Sleep Scale

 

X

 

X

 

X

X

X

X

X

Multidimensional Fatigue Inventory

 

X

 

X

 

X

X

X

X

X

SF-36 Health Survey

 

X

 

X

 

X

X

X

X

X

Work and Social Adjustment Scale

 

X

 

X

 

X

X

X

X

X

Beck Depression Inventory

 

X

 

X

 

X

X

X

X

X

State-Trait Anxiety Inventory

 

X

 

X

 

X

X

X

X

X

Systematic Assessment for Treatment Emergent Events

 

X

X

X

X

X

X

X

X

X

Treatment Evaluation Questionnaire

  

X

X

X

X

 

X

 

X

  1. FU, follow-up; Tx-1, first-stage treatment 1; Tx-2, second-stage treatment
  2. a Screening (full montage to rule out other sleep disorders) and baseline (sleep montage only) assessments are conducted on consecutive nights