Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (iACTforDGBI)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
研究概览
简要总结
Test of efficacy and cost-effectiveness of the iACTforDGBI intervention vs an active control group (DGBI School)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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))
- •Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 7 and ≤ 34 on the Montgomery Åsberg Depression Rating Scale (Svanborg & Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 5 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006)
- •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
- •Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).
排除标准
- •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.
研究组 & 干预措施
iACTforDGBI intervention
ACT, mindfulness, and compassion-based online intervention
干预措施: iACTforDGBI intervention (Behavioral)
DGBI School
Education on DGBI
干预措施: DGBI School (Other)
结局指标
主要结局
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
时间窗: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
时间窗: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
时间窗: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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).
次要结局
- Health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Health-related quality of life (Assessment of Quality of Life-8 Dimensions, AQoL-8D)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Health care use and productivity costs (Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness, TiC-P)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Illness-related shame (Chronic Illness-related Shame Scale, CISS)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Psychological flexibility and inflexibility (Multidimensional Psychological Flexibility Inventory, MPFI)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Self-compassion (Self-Compassion Scale-Short Form, SCS-SF)(Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)(Week 0 (only expectancy sub scale), Week 4 (both subscales))
- System usability (System Usability Scale, SUS)(Week 8)
- Negative effects of treatment (Negative Effects Questionnaire, 20-item version, NEQ-20)(Week 8)
- Global impression of change (Patient Global Impression of Change, PGIC)(Week 4, Week 8, 3 months follow-up, 6 months follow-up)
- Awareness of Processes Post-Intervention Scale(Week 8)
研究者
Ines Trindade
Dr
Örebro University, Sweden