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Table 1 Instruments for measuring clinical efficacy and cost-effectiveness

From: Cost-effectiveness of the mobile application TCApp combined with face-to-face CBT treatment compared to face-to-face CBT treatment alone for patients with an eating disorder: study protocol of a multi-centre randomised controlled trial

Dimension

Methodology

Assessment measures

Stakeholder

T0

T1

T2

Clinical efficacy

 Psychopathology

Clinical interview

Minors (6-18 years old): Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) (DSM-5)

Adults: Structured Clinical Interview for DSM Disorders (SCID-I)

Patient

x

  

 Physical and clinical variables

Brief clinical interview

Comorbidities, medication, illness duration, Body Mass Index, among others

Patient

x

x

x

 Eating Disorder psychopathology

Questionnaire

- Eating Disorders Examination Questionnaire (EDE-Q)

- Short Evaluation of Eating Disorders (SEED)

Patient

x

x

x

 Depression

Questionnaire

Beck Depression Inventory-II (BDI-II)

Patient

x

x

x

 Anxiety

Questionnaire

State-Trait Anxiety Inventory (STAI)

Patient

x

x

x

 Motivation to change

Questionnaire

Patients with Anorexia Nervosa: Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ)

Patients with Bulimia Nervosa or Binge Eating Disorder: Bulimia Nervosa Stages of Change Questionnaire (BNSOCQ)

Patient

x

x

x

 Dropout

Telephone interview

Reasons for dropout

Clinician responsible for the online monitoring

 

x

x

 Risk of suicide

Questionnaire

Beck Hopelessness Scale (BHS) / Suicide Intent Scale (SIS)

Patient / Clinician responsible for the online monitoring

x

x

x

 Quality of life

Questionnaire

12-14 years old: EQ-5D-Y (children version)

> 14 years old: EQ-5D-5 L

Patient

x

x

x

 Caregiving experience

Questionnaire

Experience of Caregiving Inventory (ECI)

Family caregiver

x

x

x

 Quality of life

Questionnaire

EQ-5D-5 L

Family caregiver

x

x

x

Cost-utility and cost-effectiveness analysis

 Cost related to the development and maintenance of the online platform

Telephone interview

Staff involved, number of extra hours x pay rate/hour

Technical staff

x

x

 

 Costs related to healthcare utilization, medication and school and / or work absenteeism

Questionnaire

iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) / iMTA questionnaire for Costs associated with Psychiatric Illness, Parent-Form (TiC-P Children)

Adult patient / family caregiver (referring to minor patient)

x

x

x

 Patient’s healthcare utilization

Telephone interview

Number of visits to ED specialists, number of visits to the emergency department, medication consumption and its costs

Clinician responsible for the online monitoring

x

x

x

 Cost of implementing the online intervention

Telephone interview

Clinicians involved, number of extra hours for online monitoring x pay rate/hour

Clinician responsible for the online monitoring

 

x

 

 Usability and satisfaction

Questionnaire

- Client Satisfaction Questionnaire (CSQ-8)

- System Usability Scale (SUS)

ED specialists and patients from the experimental group

 

x