NCT06887751已完成不适用
Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Substudy 2)
Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Individual Interviews
研究概览
简要总结
The goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are:
What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?
Participants will be asked to:
Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.
Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.
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
- None
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)
- •Severe depression (>34 points on MADRS)
研究组 & 干预措施
Acceptance and Commitment Therapy (ACT)
Experimental
Acceptance and Commitment Therapy (ACT)
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Psychoeducation
Active Comparator
Psychoeducation
干预措施: Psychoeducation (Other)
结局指标
主要结局
Individual Interviews
时间窗: At post treatment (8 weeks)
Feasibility and Acceptability of intervention
次要结局
- The Generalized Anxiety Disorder scale-7 (GAD-7)(At pre and post treatment (0 and 8 weeks), 6-month follow-up (FU1), and 12-month follow-up (FU2) assessments)
- EQ-5D-5L(At pre and post treatment (0 and 8 weeks))
- AQoL-8D(At pre and post treatment (0 and 8 weeks))
- The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(At pre and post treatment (0 and 8 weeks))
- The Intervention Acceptability Scale(At post treatment (8 weeks))
- The Gastrointestinal Symptom Rating Scale (GSRS)(At pre and post treatment (0 and 8 weeks))
- The Chronic Illness Shame Scale (CISS)(At pre and post treatment (0 and 8 weeks))
- The Credibility / Expectancy Questionnaire (CEQ)(After session 2 (2 weeks))
- The System Usability Scale (SUS)(At post treatment (8 weeks))
- The Negative Effects Questionnaire (NEQ-20)(At post treatment (8 weeks))
- The Contextual Therapies Process Awareness Scale(At post treatment (8 weeks))
- The Patient Health Questionnaire-9 (PHQ-9)(At pre and post treatment (0 and 8 weeks))
- The Multidimensional Psychological Flexibility Inventory (MPFI)(At pre and post treatment (0 and 8 weeks))
- The State Self-Compassion Scale - short Form (SSCS-S)(At pre and post treatment (0 and 8 weeks))
- The Self-Compassion Scale - short Form (SCS-SF)(At pre and post treatment (0 and 8 weeks))
研究者
研究点 (1)
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