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Clinical Trials/NCT05405855
NCT05405855
Completed
Not Applicable

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

University of Coimbra1 site in 1 country80 target enrollmentJanuary 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
University of Coimbra
Enrollment
80
Locations
1
Primary Endpoint
Psychological distress (DASS-21; Lovibond & Lovibond, 1995)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
October 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inês A Trindade

Principal Investigator

University of Coimbra

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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