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Inflammatory Bowel DiseaseseLIFEwithIBDNCT05405855

eLIFEwithIBD - Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease (Online)

A study testing eLIFEwithIBD in people with Inflammatory Bowel Diseases, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
eLIFEwithIBD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePortugal
Study dates
5 Jan 2022to 15 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Inês Trindade

    Coimbra, 3000-115

Other trials in Portugal

About this study

Official title: eLIFEwithIBD (Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease): The Impact of an ICT-based Intervention on Physical and Mental Health

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.

Being tested
eLIFEwithIBD
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eLIFEwithIBDBehavioural

    eLIFEwithIBD program is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients.

Study groups in NCT05405855
Study groupRoleWhat they receive
Experimental GroupExperimentalThe 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.
Receives: Behavioral: eLIFEwithIBD
Control GroupNo interventionTreatment as Usual (TAU) - Standard, personalised treatment for inflammatory bowel disease.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological distress (DASS-21; Lovibond & Lovibond, 1995)

    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)].

    Measured: From Baseline to 4-months follow-up

Secondary outcomes (4)

  1. Perception of Quality of Life - EUROHIS-QOL 8-item index (Power, 2017); Inflammatory Bowel Disease Questionnaire - UK version (IBDQ-UK; Cheung et al., 2000)

    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.

    Measured: From Baseline to 4-months follow-up

  2. Chronic illness-related shame (Chronic Illness-related Shame Scale - CISS, Trindade et al., 2017)

    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)].

    Measured: From Baseline to 4-months follow-up

  3. IBD symptom perception (IBD symptoms scale, Trindade et al., 2019)

    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)].

    Measured: From Baseline to 4-months follow-up

  4. Functional impairment (Work and Social Adjustment Scale - WSAS; Mundt et al., 2002)

    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)].

    Measured: From Baseline to 4-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start5 Jan 2022
  3. Primary completion1 Aug 2022
  4. Study completion15 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405855
Sponsor's protocol ID
CINEICC-2-IAT
Acronym
eLIFEwithIBD
Status last verified
Nov 2022
First submitted
27 May 2022
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

    PubMed 40243391

  • Ferreira C, Pereira J, Matos-Pina I, Skvarc D, Galhardo A, Ferreira N, Carvalho SA, Lucena-Santos P, Rocha BS, Oliveira S, Portela F, Trindade IA. eLIFEwithIBD: study protocol for a randomized controlled trial of an online acceptance and commitment therapy and compassion-based intervention in inflammatory bowel disease. Front Psychol. 2024 Aug 9;15:1369577. doi: 10.3389/fpsyg.2024.1369577. eCollection 2024.

    PubMed 39184944

Questions about this trial

What is this clinical trial studying?

A study testing eLIFEwithIBD in people with Inflammatory Bowel Diseases, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological distress (DASS-21; Lovibond & Lovibond, 1995) (time frame: From Baseline to 4-months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05405855, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.

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