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

NCT ID: NCT05405855

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

eLIFEwithIBD

Intervention Type BEHAVIORAL

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

Control Group

Treatment as Usual (TAU) - Standard, personalised treatment for inflammatory bowel disease.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eLIFEwithIBD

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Coimbra

OTHER

Sponsor Role lead

Responsible Party

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Inês A Trindade

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inês Trindade

Coimbra, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39184944 (View on PubMed)

Other Identifiers

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CINEICC-2-IAT

Identifier Type: -

Identifier Source: org_study_id

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