Inflammatory Bowel Diseases
Conditions
Brief summary
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.
Interventions
BEHAVIORALeLIFEwithIBD
eLIFEwithIBD program is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients.
Sponsors
University of Coimbra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress (DASS-21; Lovibond & Lovibond, 1995) | 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 \[ranging from did not apply to me at all (0) to applied to me very much, or most of the time (3)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Chronic illness-related shame (Chronic Illness-related Shame Scale - CISS, Trindade et al., 2017) | 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 \[fromNever true (0) to Always true (4)\]. |
| IBD symptom perception (IBD symptoms scale, Trindade et al., 2019) | 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 \[ranging from Never (0) to Always (6)\]. |
| Functional impairment (Work and Social Adjustment Scale - WSAS; Mundt et al., 2002) | 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 \[Not at all (0) to Very severely (8)\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability - System Usability Scale (SUS; Brooke, 1986) | 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). |
| Acceptability and Feasibility - The Acceptability and Feasibility Measures (Weiner et al., 2017) | 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). |
Countries
Portugal
Outcome results
None listed