Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Psychological flexibility measured with the Acceptance and Action Questionnaire-II (AAQ-II) |
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation |
|
Other |
Non-reactivity measured with a subscale of the Five Facet Mindfulness Questionnaire (FFMQ) |
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation |
|
Other |
Illness perception measured with the Brief Illness Perception Questionnaire (B-IPQ) |
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation |
|
Other |
Personality traits measured with the short version of the Big Five Inventory (BFI-10) |
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) |
|
Other |
Working alliance measured with the Working Alliance Inventory, Patient version (WAI-pt) |
|
2 weeks into treatment, and 3 months after randomisation |
|
Other |
Treatment credibility and expectancy measured with the credibility/ expectancy questionnaire |
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) |
|
Other |
Childhood history questionnaire |
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) |
|
Other |
Traumatic events in childhood measured with the Childhood traumatic event scale |
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) |
|
Other |
Attachment style measured with the questionnaire: Experiences in close relationships - relationship structures (ECR-RS) |
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) |
|
Other |
Treatment evaluation of negative effects measured with the Inventory for the assessment of negative effects of psychotherapy (INEP) |
|
9 months after randomisation |
|
Other |
Attitudes toward seeking professional help |
|
At baseline (i.e. at self-referral) and at 3 months after randomisation |
|
Other |
Self-reported health care use, work performance and work absence measured with Trimbos/ institute of Health Policy and Management (iMTA) questionnaire for Costs associated with Psychiatric Illness (TiC-P) |
|
At baseline (i.e. at self-referral) and at 9 months after randomisation |
|
Other |
Health care expenditures extracted from Danish national registers, and degree of illness related absence from work extracted from the Danish Register of Sickness absence compensation benefits and Social transfer payments database (DREAM). |
|
At baseline (i.e. at self-referral) and at 9 months after randomisation |
|
Other |
Health literacy measured with the Health Literacy Questionnaire (HLQ) |
|
At baseline (i.e. at self-referral) |
|
Other |
Values measured with the Sources of Meaning and Meaning in life questionnaire (SoMe-26) |
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation |
|
Other |
Negative events and effects of psychological treatment |
|
At 3 months after randomisation |
|
Primary |
Whiteley-7 index |
Health anxiety symptoms |
At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation |
|
Secondary |
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund) |
|
At baseline (i.e. at self-referral) |
|
Secondary |
Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund) |
|
At baseline (i.e. at self-referral) |
|
Secondary |
Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5) |
|
At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation |
|
Secondary |
Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health |
|
At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation |
|
Secondary |
Stress measured with questions from the survey Youth stress, Danish Health Authority |
|
At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation |
|
Secondary |
Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI) |
|
At baseline (i.e. at self-referral), and 3 and 9 months after randomisation |
|
Secondary |
Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92) |
|
At baseline (i.e. at self-referral), and 3 and 9 months after randomisation |
|
Secondary |
Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist) |
|
At baseline (i.e. at self-referral) |
|
Secondary |
General health status and functioning measured with the Short Form 12 Health Survey (SF-12) |
|
At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline), 3 and 9 months after randomisation |
|