eLIFEwithIBD (Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease): The Impact of an ICT-based Intervention on Physical and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Psychological distress (DASS-21; Lovibond & Lovibond, 1995)
研究概览
简要总结
This study aims to test the acceptability and preliminary efficacy of an online intervention (eLIFEwithIBD) developed for people with inflammatory bowel disease (IBD). The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD program (delivered in an in-person group format; Trindade et al., 2021), being an ACT, mindfulness, and compassion-based intervention. The eLIFEwithIBD intervention comprises nine sessions focusing on education about IBD, the functioning of the mind, emotions, and fatigue; acceptance of internal experiences; willingness; emotion regulation; values clarification; committed action; mindfulness; compassion; and gratitude. These topics are addressed through videos with therapists, texts, and experiential exercises.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 65;
- •IBD diagnosis (at least from 6 months prior);
- •regular access to a computer with internet;
- •able to write and read in Portuguese, and give informed consent.
排除标准
- •diagnosis of a psychiatric disorder (major depressive disorder, psychotic disorder, bipolar disorder, substance abuse), or suicidal ideation (assessed by the Patient Health Questionnaire-9);
- •current psychotherapy use;
- •pregnancy.
研究组 & 干预措施
Experimental Group
The eLIFEwithIBD intervention is an ACT, mindfulness and compassion eHealth intervention for people with inflammatory bowel disease (IBD). The eLIFEwithIBD intervention is delivered through 9 sessions available on an online platform throughout a 9-week period. Each session is composed of real-image videos, texts with illustrative images, exercises in editable text format, and audio files with the experiential exercises and practices targeting topics such as acceptance, mindfulness, compassion, and gratitude.
Participants in this group also continue to receive a standard, personalised treatment for IBD.
干预措施: eLIFEwithIBD (Behavioral)
Control Group
Treatment as Usual (TAU) - Standard, personalised treatment for inflammatory bowel disease.
结局指标
主要结局
Psychological distress (DASS-21; Lovibond & Lovibond, 1995)
时间窗: From Baseline to 4-months follow-up
The DASS-21 is a 21-item measure of depressive (e.g., "I felt I wasn't worth much as a person"), anxiety (e.g., "I felt scared without any good reason"), and stress (e.g., "I found it hard to wind down") symptoms during the precedent week, using a 4-point scale \[ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3)\].
次要结局
- IBD symptom perception (IBD symptoms scale, Trindade et al., 2019)(From Baseline to 4-months follow-up)
- Functional impairment (Work and Social Adjustment Scale - WSAS; Mundt et al., 2002)(From Baseline to 4-months follow-up)
- Perception of Quality of Life - EUROHIS-QOL 8-item index (Power, 2017); Inflammatory Bowel Disease Questionnaire - UK version (IBDQ-UK; Cheung et al., 2000)(From Baseline to 4-months follow-up)
- Chronic illness-related shame (Chronic Illness-related Shame Scale - CISS, Trindade et al., 2017)(From Baseline to 4-months follow-up)
研究者
Inês A Trindade
Principal Investigator
University of Coimbra