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
Open accessAbstract
Background: There is ample evidence of the high mental health burden caused by Inflammatory Bowel Disease (IBD). Several constructs such as experiential avoidance, cognitive fusion, shame, and self-criticism have recently emerged as potential intervention targets to improve mental health in IBD. Psychotherapeutic models such as Acceptance and Commitment Therapy and compassion-based interventions are known to target these constructs. In this protocol, we aim to describe a two-arm Randomized Controlled Trial (RCT) testing the efficacy of an ACT and compassion-focused intervention named Living with Intention, Fullness, and Engagement with Inflammatory Bowel Disease (LIFEwithIBD) intervention + Treatment As Usual (TAU) vs. TAU in improving psychological distress, quality of life, work and social functioning, IBD symptom perception, illness-related shame, psychological flexibility, self-compassion, disease activity, inflammation biomarkers, and gut microbiota diversity. Methods: This trial is registered at ClinicalTrials.gov (Identifier: NCT03840707, date assigned 13/02/2019). The LIFEwithIBD intervention is an adaptation to the IBD population of the Mind programme for people with cancer, an acceptance, mindfulness, and compassion-based intervention designed to be delivered in a group format. The LIFEwithIBD intervention's structure and topics are presented in this protocol. Participants were recruited at the Gastroenterology Service of the Coimbra University Hospital between June and September 2019. Of the 355 patients screened, 61 participants were selected, randomly assigned to one of two conditions [experimental group (LIFEwithIBD + TAU) or control group (TAU)] and completed the baseline assessment. Outcome measurement took place at baseline, post-intervention, 3- and 12-month follow-ups. Discussion: Results from this RCT will support future studies testing the LIFEwithIBD intervention or other acceptance and/or compassion-based interventions for IBD.
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Both previous ACT trials in IBD use an inactive control group (treatment as usual).
“Both these trials use an inactive control group (ie, treatment as usual).”
From Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme (2022) · cites this paper as [20]
The Introduction says the one previously conducted ACT RCT in IBD compared its intervention with treatment as usual (TAU). The Aims and Discussion say the LIFEwithIBD trial also uses a TAU-only, inactive control. The paper therefore supports the control-group comparison for two trials, but not the claim that both were previous trials: it describes LIFEwithIBD as the current trial and says only one IBD ACT RCT had previously been performed. (LLM, conf=0.88)
Experimental — accuracy not yet measuredMost studies testing psychotherapy for depression/anxiety in IBD do not screen for these symptoms prior to recruitment.
“most studies do not screen for these symptoms prior to recruitment to ensure that participants were experiencing at least mild-moderate symptoms of anxiety/depression (or overall psychological distress) prior to receiving the intervention.12,17”
From Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress. (2024) · cites this paper as [12]
In Methods and Analysis > Participant Recruitment (page unavailable), the LIFEwithIBD protocol lists no minimum anxiety, depression, or distress level for eligibility; it instead excludes severe depression and certain psychiatric disorders. This supports the protocol as one example, but the paper does not establish that most IBD psychotherapy studies omit such screening. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAnother trial of ACT in IBD is currently in progress.
“Another trial is currently in progress.20”
Only 2 trials to date have examined ACT in the context of IBD, with only 1 trial completed thus far.
“only 2 trials to date have examined ACT in the context of IBD,12,13 with only 1 trial having been completed thus far.”
From Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress. (2024) · cites this paper as [12]
Both ACT trials in IBD used an inactive control group rather than an active control group as a comparison.
“both trials made use of an inactive control group (eg, treatment as usual) rather than an active control group as a comparison.”
From Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress. (2024) · cites this paper as [12]
The present study reports a recruitment rate that is similar to face-to-face psychotherapy programs.
“the present study reports a recruitment rate that is similar to face-to-face psychotherapy programs.12,25”
From Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress. (2024) · cites this paper as [12]
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The Role of Self-Compassion for Adjustment to Inflammatory Bowel Disease
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Research Progress of Stigma in Patients with Inflammatory Bowel Disease
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- Authors
- Trindade, I. A., Pereira, J., Galhardo, A., Ferreira, N. B., Lucena-Santos, P., Carvalho, S. A., Oliveira, S., Skvarc, D., Rocha, B. S., Portela, F., & Ferreira, C.
- Affiliations
- University of Coimbra (PT)
- Instituto Superior Miguel Torga (PT)
- University of Nicosia (CY)
- Universidade Lusófona de Humanidades e Tecnologias (PT)
- Deakin University (AU)
- Unidade Local de Saúde de Coimbra (PT)
- Corresponding author
- Trindade, Inês A.
- Ferreira, Cláudia
- ORCID
- Venue
- Frontiers in Psychiatry
- Publisher
- Frontiers Media SA
- Published
- 2021-08-19
- Volume
- 12
- Pages
- 699367-699367
- ISSN
- 1664-0640 (ISSN-L)
- PMC
- PMC8417328
- OpenAlex
- W3194492511
- Cited by
- 20
- References
- 83
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 6 · 2023: 3 · 2022: 3
- FWCI
- 2.05
- Type
- journal article
- Language
- en
- Update notices
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Own your potential (DEAKIN) (submittedVersion)
- Estudo Geral (Universidad de Coimbra) (submittedVersion, cc-by)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, other-oa)
- Figshare (submittedVersion, cc-by)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion)
- Funders
- Fundação para a Ciência e a Tecnologia
- Topics
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- inflammatory bowel disease, acceptance and commitment therapy, compassion-focused therapy, psychological distress, quality of life, self-compassion, psychological flexibility, experiential avoidance, gut microbiota, inflammatory markers, group therapy, mental health
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