Efficacy and Cost Effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- The Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and cost-effectiveness of the iACTforDGBI intervention among adults with Disorders of Gut-Brain Interaction (DGBI) and psychological distress. The main questions it aims to answer are: What is the efficacy of iACTforDGBI vs DGBI School? What is the cost-effectiveness of iACTforDGBI vs DGBI School? Who are the responders of each intervention? What are the moderators and mechanisms of change of the interventions? Participants will be asked to: Complete one of the two interventions (to which they will be randomly allocated to). Both interventions are 8-session online programs, delivered via an interactive platform and tailored for Swedish-speaking adults with symptoms compatible with a DGBI and psychological distress. Both interventions are theory-based and expected to be beneficial. Participants will be asked to fill out online questionnaires for screening of study eligibility, and baseline, post-treatment and follow-up outcome measures to evaluate the intervention. A subsample will also be interviewed post treatment.
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)
盲法说明
Researcher responsible for randomization and allocation
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 ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg & Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 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
Acceptance and Commitment Therapy with explicit self-compassion training
Acceptance and Commitment Therapy with explicit self-compassion training
干预措施: Acceptance and Commitment Therapy with explicit self-compassion training (Behavioral)
Education about DGBI and distress
Education
干预措施: Education (Other)
结局指标
主要结局
The Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up)
Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms
The Generalized Anxiety Disorder scale-7 (GAD-7)
时间窗: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms
The Patient Health Questionnaire-9 (PHQ-9)
时间窗: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
symptoms of depression, total score 0-27, higher = worse depressive symptoms
次要结局
- Major Life Events(T0 (week 0), T3 (6 month follow-up))
- EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life(T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- Assessment of Quality of Life - 8 dimensions (AQoL-8D)(T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- The Chronic Illness Shame Scale (CISS)(T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- The Credibility / Expectancy Questionnaire (CEQ)(T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales))
- The System Usability Scale (SUS)(T1 (week 8))
- The Negative Effects Questionnaire (NEQ-20)(T1 (week 8))
- Global Impression of Change Scale(Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- Awareness of Processes Post-Intervention Scale(T1 (week 8))
- The Multidimensional Psychological Flexibility Inventory (MPFI)(T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- Self-Compassion Scale(T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))
- Insomnia Severity Index(T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up))