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Inflammatory Bowel DiseasesLIFEwithIBDNCT03840707

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

A study testing LIFEwithIBD in people with Inflammatory Bowel Diseases, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
LIFEwithIBD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 sitePortugal
Study dates
27 May 2019to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra

Other trials in Portugal

About this study

Official title: LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease: The Impact of a Group Intervention and an ICT-based Transcultural Intervention on Physical and Mental Health

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.

Read the detailed description

The sample will include diagnosed inflammatory bowel disease patients recruited at a Gastroenterology Service at the Coimbra's University Hospital, a national reference centre for IBD. Patients will be approached by their doctor to assess their level of interest in the investigation. Patients who demonstrate interest will go through a Screening interview conducted by a psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the patient meets the inclusion criteria for the study. After sample collection, participants will be randomly assigned to one of two conditions: experimental group (n=75) or control group (n=75). The experimental group will be divided into five subgroups of 15 participants. The first group will function as a pilot group to test the suitability of the programme. The intervention will include 8 weekly sessions, with the duration of 90 minutes each. Groups will have two therapists with experience in ACT and CFT-based interventions. All participants will continue on receiving the recommended pharmacological treatment for IBD (TAU). This will allow the comparison between the participants receiving the LIFE-IBD Group Intervention+TAU (experimental group) and the participants only receiving TAU (control group). The frequency of engagement with the programme at home practises will be analysed as moderator of the efficacy of the programme. Both groups will concurrently complete a protocol of measures to assess main three areas: a) psychological processes; b) quality of life and psychopathology; c) current medical status. These assessments will occur in four different times: before the start of the LIFEwithIBD programme M0), after the final session of the programme (M1), and 3 (M2) and 6 months (M4) after that.

Being tested
LIFEwithIBD
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIFEwithIBDBehavioural

    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

Study groups in NCT03840707
Study groupRoleWhat they receive
Experimental groupExperimentalLIFEwithIBD 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.
Receives: Behavioral: LIFEwithIBD
Control groupNo interventionTreatment as Usual (TAU) Standard personalized treatment of inflammatory bowel disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Baseline to 3-months follow-up

Secondary outcomes (3)

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

    Quality of life will be measure by World Health Organization Brief Quality of Life Assessment Scale.The WHOQOL-BREF is a 24-item measure of subjective perceptions of QoL. Items are rated on a 5-point Likert scale (higher scores indicate perceptions of higher QoL) and are distributed over four domains-physical health (e.g. "To what extent do you feel that physical pain prevents you from doing what you need to do?"), psychological health (e.g. "How often do you have negative feelings such as blue mood, despair, anxiety, depression?"-reverse item),social relationships (e.g. "How satisfied are you with your personal relationships?"), and environment. The scale also presents two additional items that evaluate general quality of life and general health.

    Measured: From Baseline to 3-months follow-up

  2. Biochemical indicator: concentration levels of calprotectin

    This biochemical indicator will be measured though concentration levels of calprotectin in unit of measure of miligram/liter (mg/L)

    Measured: From Baseline to 3-months follow-up

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

    This biochemical indicator will be measured though concentration levels of C-reactive protein (CRP) in unit of measure of microgram/gram (µg/g)

    Measured: From Baseline to 3-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start27 May 2019
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840707
Sponsor's protocol ID
CHUC-068-18
Acronym
LIFEwithIBD
Status last verified
Nov 2021
First submitted
5 Feb 2019
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38784617

  • 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.

    PubMed 34489756

Questions about this trial

What is this clinical trial studying?

A study testing LIFEwithIBD in people with Inflammatory Bowel Diseases, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Indicators of psychopathology (DASS-21) (time frame: From Baseline to 3-months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840707, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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