LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease

NCT03840707 | Completed

• 1 other identifier: CHUC-068-18
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation aims to apply and test the feasibility of an acceptance, mindfulness and compassionate-based intervention structured for inflammatory bowel disease patients. LIFEwithIBD programme for inflammatory bowel disease thus comprises 9 weekly group sessions, lasting 1 and a half hour each, run in small groups at a Gastroenterology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). The efficacy of LIFE-IBD Group Intervention to improve quality of life, mental health, and disease activity-related scores will be tested in a sample of Portuguese patients. Additionally, this study expected that the observable changes after the intervention completion will be attributed to changes in emotional regulation processes and maintained over the follow-up periods.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Indicators of psychopathology (DASS-21)

  Indicators of psychopathology, namely depression, anxiety and stress symptoms will be measured by Depression, Anxiety and Stress Scale-21. DASS-21 assesses levels of depression, anxiety, and stress symptoms. Respondents are asked to indicate how frequently they experienced such symptoms over the previous week on a 4-point scale (ranging from 0 = "Did not apply to me at all" to 3 = "Applied to me very much, or most of the time"). Results of each subscale are calculated by the sum of the results of the seven items. The scale provides three notes, one per subscale, where the minimum is "0" and the maximum is "21". Higher results correspond to more negative affective states.

  From Baseline to 3-months follow-up

Secondary Outcomes (3)

• Perception of Quality of Life (World Health Organization Brief Quality of Life Assessment Scale)

  From Baseline to 3-months follow-up

• Biochemical indicator: concentration levels of calprotectin

  From Baseline to 3-months follow-up

• Biochemical indicator: concentration levels of C-reactive protein (CRP)

  From Baseline to 3-months follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

LIFEwithIBD Programme is a manualized acceptance, mindfulness and compassionate-based group intervention for inflammatory bowel disease patients. It included 9 weekly group sessions, 1.30h hours each, run in small groups (ranging from 10 to 15 participants). Participants in this group also receive inflammatory bowel disease treatment as usually performed at the Coimbra University Hospital.

Behavioral: LIFEwithIBD

Control group

NO INTERVENTION

Treatment as Usual (TAU) Standard personalized treatment of inflammatory bowel disease

Interventions

LIFEwithIBD BEHAVIORAL

LIFEwithIBD programme is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients Treatment as Usual (TAU): Standard personalized treatment of inflammatory bowel disease

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:

• diagnosis of IBD for more than 6 months (CD or UC)

You may not qualify if:

• having started new treatment for IBD in the previous 6 months (in the case of anti-TNF and immunosuppressive therapy) or 2 months (in the case of steroid or aminosalicylate therapy)
• cognitive impairment;
• currently undergoing any form of psychological intervention;
• current diagnosis of severe psychiatric illness (severe depression, psychotic illness, bipolar disorder, substance abuse) or suicidal ideation;
• diagnosis of other serious health condition;
• pregnancy.

Sponsors & Collaborators

• University of Coimbra: lead
• Unidade Local de Saúde de Coimbra, EPE: collaborator

Study Sites (1)

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Location

Related Publications (2)

• Ferreira C, Pereira J, Skvarc D, Oliveira S, Galhardo A, Ferreira NB, Lucena-Santos P, Carvalho SA, Matos-Pina I, Rocha BS, Portela F, Trindade IA. Randomized controlled trial of an Acceptance and Commitment Therapy and compassion-based group intervention for persons with inflammatory bowel disease: the LIFEwithIBD intervention. Front Psychol. 2024 May 9;15:1367913. doi: 10.3389/fpsyg.2024.1367913. eCollection 2024.

  PMID: 38784617 DERIVED

• Trindade IA, Pereira J, Galhardo A, Ferreira NB, Lucena-Santos P, Carvalho SA, Oliveira S, Skvarc D, Rocha BS, Portela F, Ferreira C. The LIFEwithIBD Intervention: Study Protocol for a Randomized Controlled Trial of a Face-to-Face Acceptance and Commitment Therapy and Compassion-Based Intervention Tailored to People With Inflammatory Bowel Disease. Front Psychiatry. 2021 Aug 19;12:699367. doi: 10.3389/fpsyt.2021.699367. eCollection 2021.

  PMID: 34489756 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: Dr

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 15, 2019
• Study Start: May 27, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

PT (1)