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

NCT05405855 | Completed

• 1 other identifier: CINEICC-2-IAT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (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 \[ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3)\].

  From Baseline to 4-months follow-up

Secondary Outcomes (4)

• 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

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

  From Baseline to 4-months follow-up

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

  From Baseline to 4-months follow-up

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

  From Baseline to 4-months follow-up

Other Outcomes (2)

• Usability - System Usability Scale (SUS; Brooke, 1986)

  9 weeks

• Acceptability and Feasibility - The Acceptability and Feasibility Measures (Weiner et al., 2017)

  9 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: eLIFEwithIBD

Control Group

NO INTERVENTION

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

Interventions

eLIFEwithIBD BEHAVIORAL

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Inês Trindade

Coimbra, 3000-115, Portugal

Location

Related Publications (2)

• 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.

  PMID: 40243391 DERIVED

• 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.

  PMID: 39184944 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 6, 2022
• Study Start: January 5, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 15, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

PT (1)