Test of efficacy and cost-effectiveness of the iACTforDGBI intervention vs an active control group (DGBI School)
Age between 18 and 75 years
Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016))
Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.
Ability to read and write Swedish
Currently undergoing any form of psychological intervention.
Increased risk of suicide (≥4 points on MADRS item 9).
Ongoing or previously diagnosed severe psychiatric disorder, such as schizophrenia spectrum disorders or bipolar disorder.
Parallel
iACTforDGBI intervention
BehavioralOnline ACT, mindfulness, and compassion-based intervention, 8 sessions
DGBI School
Other interventionEducation on DGBI, diet, and psychological factors
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale. Each item is rated from 0 (not at all) to 3 (nearly every day) and items are summed. Total score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms (worse outcome).
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS)
Gastrointestinal symptom severity measured with the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report scale. Each item is rated on a 7-point Likert scale from 1 (no discomfort) to 7 (very severe discomfort), and items are summed. Total score ranges from 15 to 105. Higher scores indicate more severe gastrointestinal symptoms (worse outcome).
Anxiety symptoms (Generalized Anxiety Disorder 7-item scale, GAD-7)
Anxiety symptoms measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Each of the 7 items is rated from 0 (not at all) to 3 (nearly every day) and items are summed. Total score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms (worse outcome).
Health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L)
Health-related quality of life measured with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five severity levels, are converted into a single index value using the \[Swedish c-TTO value set (Sun et al., 2022) / Swedish experience-based value set (Burström et al., 2020)\]. The index is anchored at 1.00 (full health) and 0.00 (a state equivalent to dead), with negative values representing states considered worse than dead; the \[Swedish c-TTO value set ranges from -0.31 to 1.00 / Swedish experience-based value set ranges from 0.243 to 0.976\]. Higher index values indicate better health-related quality of life (better outcome). The accompanying EQ visual analogue scale ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better self-rated health.
Health-related quality of life (Assessment of Quality of Life-8 Dimensions, AQoL-8D)
Health-related quality of life measured with the Assessment of Quality of Life-8 Dimensions (AQoL-8D), a 35-item instrument covering eight dimensions (independent living, happiness, mental health, coping, relationships, self-worth, pain, senses). Item responses are converted into a single utility score using the Australian scoring algorithm, on a scale anchored at 1.00 (full health) and 0.00 (dead); the algorithmic range is 0.09 to 1.00. Higher scores indicate better health-related quality of life (better outcome).
Health care use and productivity costs (Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness, TiC-P)
Health care utilisation and productivity losses measured with the Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (TiC-P). The TiC-P is not scored as a rating scale: reported numbers of health care contacts and days of absenteeism and reduced productivity are multiplied by Swedish unit costs to yield costs in SEK. The minimum is 0 SEK and there is no fixed maximum. Higher values indicate greater resource use and productivity loss (worse outcome).
Illness-related shame (Chronic Illness-related Shame Scale, CISS)
Illness-related shame measured with the Chronic Illness-related Shame Scale (CISS), a 7-item unidimensional self-report scale. Each item is rated from 0 (never true) to 4 (always true) and items are summed. Total score ranges from 0 to 28. Higher scores indicate greater illness-related shame (worse outcome).
Major Life Events Questionnaire
Major life events and self-reported new psychological or physical diagnoses over the preceding 12 months, measured with the Major Life Events Questionnaire, a 28-item checklist. This is not scored as a rating scale; the outcome is the number of events endorsed, ranging from 0 to 28. A higher number indicates more major life events reported. This measure is used to characterise the sample and to identify potential confounders rather than as an efficacy outcome.
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