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Table 1 Overview of assessments and measures

From: Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD).

 

T0

(baseline)

MBCT

T1

(3 months)

T2

(6 months)

T3

(9 months)

T4

(12 months)

Self-report questionnaires

Psychological distress

HADS

✓

 

✓

✓

✓

✓

Sleep quality and fatigue

PSQI

✓

 

✓

✓

✓

✓

ISI

✓

 

✓

✓

✓

✓

FACIT-F

✓

 

✓

✓

✓

✓

IBD-related measures

SIBDQ

✓

 

✓

✓

✓

✓

IBD-control

✓

 

✓

✓

✓

✓

Mental health-related measures

PTQ

✓

 

✓

✓

✓

✓

FFMQ-SF

✓

 

✓

✓

✓

✓

SCS-SF

✓

 

✓

✓

✓

✓

MHC-SF

✓

 

✓

✓

✓

✓

MAQ

 

✓

✓

✓

✓

✓

Cost-effectiveness

TiC-P

✓

 

✓

✓

✓

✓

EQ-5D

✓

 

✓

✓

✓

✓

Clinical interview

HBI/SCCAI

✓

 

✓

✓

✓

✓

Time to flare

✓

 

✓

✓

✓

✓

(S)AE

✓

 

✓

✓

✓

✓

Clinical outcomes

Blood tests*

✓

 

(✓)

✓

(✓)

✓

Faecal calprotectin

✓

 

(✓)

✓

(✓)

✓

Sleep analysis

Headband (Zmax)

✓

 

✓

   

Wristband (Fitbit)

✓

✓

✓

   
  1. Abbreviations: EQ-5D, EuroQol-5D-5 L; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FFMQ-SF, Five Facet Mindfulness Questionnaire-Short Form; HADS, Hospital Anxiety and Depression Scale; HBI, Harvey Brashaw Index; IBD, Inflammatory Bowel Disease; ISI, Insomnia Severity Index; MAQ, Mindfulness Adherence Questionnaire; MBCT, Mindfulness-Based Cognitive Therapy; MHC-SF, Mental Health Continuum-Short Form; PSQI, Pittsburgh Sleep Quality Inventory; PTQ, Perseverative Thinking Questionnaire; (S)AE, (Serious) Adverse Events; SCCAI, Simple Clinical Colitis Activity Index; SCS-SF, Self-Compassion Scale-Short Form; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; TiC-P, Trimbos iMTA Questionnaire for Costs associated with Psychiatric Illness
  2. *Blood tests consists of haemoglobin, C-reactive protein and albumin. At baseline ferritin is added.