LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): LIFEwithIBD
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment