Months | |||||||
---|---|---|---|---|---|---|---|
Instrument | 0 | 2 | 4 | 6 | 8 | 12 | |
Respondent: X=Patient; P=Parent | |||||||
Primary outcome | |||||||
Physical health | SF-3656 57 | X | X | X | X | X | X |
Secondary outcomes | |||||||
Illness severity | SCL-som58 | X | X | X | X | X | X |
BDS checklist59 | X | X | |||||
Symptom interference | LI52 | XP | XP | X | XP | ||
Depression and anxiety score | SCL-8-6-458 60–62 | X | X | X | X | ||
Mental health | SF-3656 57 | X | X | X | X | X | X |
Illness worry | Whiteley-763 | X | X | X | X | X | X |
Perceived stress | PSS64 | X | X | ||||
Overall impression of change | PGIC65 | XP | X | XP | |||
Process measures | |||||||
Illness perception | BIPQ66 | XP | X | X | XP | X | XP |
Illness related behaviour | BRIQ67 | X | X | X | X | X | X |
Psychological flexibility | AFQ-Y853 | X | X | X | X | X | X |
PIPS-1254 | X | X | X | X | X | X | |
Potential moderators | |||||||
Family functioning | FAD68 | XP | XP | ||||
Attachment style | ECR-RS69 | X | |||||
Negative life events | Negative life events70 | X | |||||
Physiological measures | |||||||
HRV | HRV measured with the Vagus device (resting state, standing, slow breathing, valsalva)71 | X | X | ||||
Hair cortisol | Measurement of hair cortisol in 2 strands of hair closest to the scalp (1–2 cm) | X | X | ||||
Inflammatory response | IL-6, TNF-α, high-sensitive CRP, IL-1, neopterin, CD163, HO1, MCP1 | X | X | ||||
Physical activity | Accelerometer (Actigraph wGT3X-BT) worn for 7 consecutive days72 | X | X |
AFQ-Y8, Avoidance and Fusion Questionnaire for Youth; BDS, bodily distress syndrome; BIPQ, Brief Illness Perception Questionnaire; BRIQ, Behavioural Responses to Illness Questionnaire; CRP, C reactive protein; ECR-RS, Experience in Close Relationships—Relationship Structure; FAD, Family Assessment Device (general functioning subscale); HO1, heme oxygenase-1; HRV, heart rate variability; IL-6, interleukin 6; LI, Limitation Index (Revised from Pain Interference Index); MCP1, monocyte chemoattractant protein-1; P, parent; PGIC, Patient Global Impression of Change; PIPS-12, Psychological Inflexibility in Pain Scale; PSS, Perceived Stress Scale; SCL-8-6-4, Symptom Checklist Revised-90—depression and anxiety subscales; SCL-som, Symptom Checklist Revised-90—somatisation subscale; SF-36, Short Form Health Survey; TNF-α, tumour necrosis factor-α; X, patient.