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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).