Inês Trindade
Coimbra, 3000-115, Portugal
NCT Number: NCT05405855
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Coimbra, 3000-115, Portugal
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
eLIFEwithIBD program is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients.
Time frame: 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)].
Time frame: From Baseline to 4-months follow-up
The EUROHIS-QOL 8-item index is a quality of life measure composed of eight items (regarding general health, energy, daily living activity, overall quality of life, finances, social relationships, self-esteem, and home) which were extracted from the WHOQOL-Bref. Each item has an individualized 5-point Likert scale (the same response scales used in the WHOQOL-bref).
The Inflammatory Bowel Disease Questionnaire-UK version (IBDQ-UK), which is the Anglicized 30-item version of the IBDQ (79, 80), an IBD-specific quality of life instrument. Each item is rated on a 4-point scale (three questions have an additional "non-applicable" option available) ranging from "no, no at all/none" (0) to "on 8 to 14 days (i.e., more than every other day)/Yes, all of the time" (4). Participants are asked to answer questions regarding their IBD and how it has affected their lives during the previous 2 weeks.
Time frame: From Baseline to 4-months follow-up
The CISS is a 7-item unidimensional scale that was specifically designed to evaluate shame associated with the experience of having a chronic illness and/or its related symptoms (e.g., "I feel inadequate because of my illness and symptoms," "I'm ashamed of talking with others about my illness or symptoms," "I feel that my illness is embarrassing"). Each item is rated on a 5-point Likert scale [from"Never true" (0) to "Always true" (4)].
Time frame: From Baseline to 4-months follow-up
IBD symptoms scale is a 16-item self-report Portuguese scale which was developed to evaluate the frequency of IBD symptoms during the precedent month (e.g., fatigue, abdominal pain and bloating, flatulence, diarrhea, nausea or vomiting, fever, the urgency to evacuate). Each item is rated on a 7-point scale [ranging from "Never" (0) to "Always" (6)].
Time frame: From Baseline to 4-months follow-up
The Work and Social Adjustment Scale (WSAS) is a 5-item measure of perceived functional impairment in daily activities, such as work, family, interpersonal relations, social and private leisure activities, and home management. Each item is rated on a 9-point scale ["Not at all" (0) to "Very severely" (8)].
Time frame: 9 weeks
SUS is a 10-item self-report scale aimed to evaluate product and user interface usability (e.g., the confidence and ease of use of the plafaform). Items are rated on a 5-point scale ranging from completely disagree (1) to completely agree (5).
Time frame: 9 weeks
A four-item self-report instrument measures the acceptability and feasibility of the intervention. Items are answered using a 5-point Likert scale ranging from completely disagree (1) to completely agree (5).
University of Coimbra
Other
eLIFEwithIBD (Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease): The Impact of an ICT-based Intervention on Physical and Mental Health
Acronym: eLIFEwithIBD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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