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

University of Coimbra

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Behavioral: eLIFEwithIBD

Study type: Interventional

Funder types: Other

Identifiers

NCT05405855

CINEICC-2-IAT

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Behavioral: eLIFEwithIBD

Control Group

No Intervention group

Description:

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