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Table 1 Study schedule of enrolment, allocation and assessments

From: The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

 

Enrolment

Baseline (pre-randomisation)

Allocation

Monthly monitoring (randomisation–12 months post-randomisation)

6 months post-randomisation

12 months post-randomisation

24 months post-randomisationa

Patient

Enrolment:

  Assessor checklist (eligibility screen)

X

      

  Intended treatment plan

X

      

  Informed consent

X

      

  Allocation

  

X

    

Assessment:

  Demographics

 

X

     

  Body mass index (BMI)

 

X

 

X

X

X

X

  Eating Disorder Examination interview (EDE) [58]

 

X

  

X

X

 

  Eating Disorder Examination Questionnaire (EDE-Q) [59]

      

X

  Eating Disorder Examination Questionnaire Short (EDE-QS) [60]

 

X

 

X

X

X

 

  Autism Spectrum Quotient (AQ-10) [61]

 

X

     

  Depression, Anxiety and Stress Scales-Version 21 (DASS-21) [62]

 

X

  

X

X

X

  Obsessive Compulsive Inventory-Revised (OCI-R) [63]

 

X

  

X

X

X

  Clinical Impairment Assessment (CIA) [64]

 

X

  

X

X

X

  Multidimensional Perceived Social Support Scale (MSPSS) [65]

 

X

  

X

X

X

  Work and Social Adjustment Scale (WSAS) [66]

 

X

  

X

X

X

  UCLA Loneliness Scale (Version 3) [67]

 

X

  

X

X

X

  Motivational rulers (willingness and readiness to change)

 

X

  

X

X

X

  Visual Analogue Scale (VAS) assessing treatment acceptability

 

X

  

X

X

X

  Visual Analogue Scale (VAS) assessing treatment expectations

 

X

     

  Perceived Coercion Scale - Adapted (PCS) [68]

 

X

  

X

  

  Therapeutic Environment Scale (TESS) [69]

   

X (at 3-months only)

   

  Health-related Quality of Life (EQ-5D-5L) [70]

 

X

  

X

X

X

  Adult Service Use Schedule (AD-SUS), designed for mental health populations [71, 72] and modified for AN.

 

X

  

X

X

X

  Covid-19 diagnosis and symptom checklist

 

X

  

X

X

X

Carer involvement (optional)

Enrolment:

  Informed consent

X

      

Assessment:

  Demographics

 

X

     

  Eating Disorder Symptom Impact Scale (EDSIS) [73]

 

X

  

X

X

X

  Depression, Anxiety and Stress Scales-Version 21 (DASS-21) [62]

 

X

  

X

X

X

  1. aThe 24-month post-randomisation assessment will be collected as part of a separate follow-up study. Approximately 60% of these will be collected during the current funding period and the remaining 40% will be subject to additional funding from the National Institute for Health and Care Research (NIHR)