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Table 1 Complete list of assessments and measures

From: The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

  Recruitment/screening Baseline assessment Visit 1 Monitoring calls Post-intervention follow-up assessment Post-intervention follow-up assessment 6 Month post-intervention follow-up assessment Early termination
Time-point (Week) - 4 1 3 4 and 8 12 14 36  
Assessments
Informed consent X X       
Inclusion/exclusion criteria X X       
Self report measures   X   X X   X  
Sleep diary   X    X   X  
Actigraphy   X    X    
Psychiatric assessment   X    X    X
Medical check-up*   X X   X    
Monitor for suicidality*   X X   X    X
Adverse events*    X   X    X
Forms/measures
Depression (QIDS) X        
Restless legs (RLS) X        
Insomnia (ISI) X X   X X   X  
Obstructive sleep apnea (Berlin questionnaire) X        
Psychiatric diagnosis (SCID)   X    X    
Global functioning (GAF)   X    X    
Depression (HAM-D)   X X   X    
Anxiety (HAM-A)   X    X    
Disease burden (CIRS-G)   X       
Social and occupational functioning (SOFAS)   X    X    
Cognition (MMSE)   X       
Depression (CES-D)   X   X X   X  
Anxiety (STPI)   X    X   X  
Sleep (DBAS)   X    X   X  
Sleep (MEQ)   X       
Health and wellbeing (SF-12)   X    X   X  
Alcohol use (AUDIT)   X    X   X  
Physical activity   X    X   X  
Personality (Locus of control)   X       
Program evaluation      X    
  1. *Additional clinical reviews will be scheduled on an individual basis in accordance with personalised depression treatment plan.
  2. Key to Abbreviated Forms/Measures: QIDS (Quick Inventory of Depressive Symptomatology); RLS (Restless Legs Syndrome Rating Scale); ISI (Insomnia Severity Index); SCID (Structured Clinical Interview for DSM-IV Disorders); GAF (Global Assessment of Functioning); HAM-D (Hamilton Rating Scale for Depression); HAM-A (Hamilton Anxiety Rating Scale); CIRS-G (Cumulative Illness Rating Scale for Geriatrics); MMSE (Mini Mental State Examination); CES-D (Center for Epidemiologic Studies Depression Scale); STPI (State Trait Personality Inventory); DBAS (Dysfunctional Beliefs About Sleep Scale); MEQ (Morning-Eveningness Questionnaire); SF-12 (Short Form 12-Item Survey); AUDIT (Alcohol Use Disorders Identification Test).