Acceptance and Commitment Therapy (ACT) in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's
      disease and ulcerative colitis. These illnesses often arise at a young age and can be
      associated with significant physical disability. In addition, there is considerable
      psychosocial disability associated with IBD. Previous studies have suggested that simple
      psychological interventions may be valuable in improving quality of life and may even improve
      disease activity. However, there has been no comprehensive trial to determine the precise
      effect of psychological interventions on quality of life (QOL), stress or disease activity.
      Our aim is to conduct a randomised controlled trial of a simple psychological intervention to
      determine it's effect on QOL and stress
    

Detailed description: 
      The inflammatory bowel diseases (IBD), which include Crohn's disease and ulcerative colitis,
      are chronic conditions that often arise in young patients and may lead to a lifetime of
      physical disability. Psychological disabilities are also prevalent in patients with chronic
      diseases and epidemiological studies indicate that IBD patients are at increased risk of
      anxiety and mood disorders, with depression rates more than double that of matched community
      samples (27% versus 12%). IBD patients are also at increased risk of illness-related
      psychological difficulties including body image concerns, sexual problems and reduced
      self-esteem.

      Therapeutic approaches to inflammatory bowel disease naturally focus on treatments that
      minimise disease activity and normalise physical function. Thus, there has been considerable
      research conducted on 5 ASA medications, steroids, immune modulators and biologic agents. In
      contrast, little attention has been paid to important, but 'low-technology', issues including
      quality of life and psychological comorbidities including depression, anxiety, stress,
      altered body image, sexuality, illness attitudes, self-esteem and other psychosocial IBD
      co-morbidities. Nevertheless, patient reported data and outcomes are increasingly being
      incorporated into research that informs strategic healthcare documents that, in turn, help
      formulate healthcare policy. Contemporary European and British guidelines now emphasise the
      benefits of a patient centred service that supplies psychological as well as medical support.

      In addition to the burden that psychological disease places upon IBD patients, there is
      evidence that psychological morbidity and stress is also associated with disease activity.
      IBD patients with depression experience more disease flares than those with no diagnosable
      psychological condition and a Canadian study has also suggested that stress can be associated
      with disease flares. In contrast, a Spanish study on 163 patients concluded that stressful
      life events do not trigger exacerbations in IBD patients. Overall, it is likely that the
      relationship between stress and disease activity is bi-directional with each one influencing
      the other to some extent.

      To date, interventions aimed at reducing psychological distress in IBD have tended to focus
      on either psychological education, stress management including relaxation techniques and
      autogenic training, psychodynamic psychotherapy, cognitive behavioral therapy and hypnosis.
      Studies have been variable with regard to psychological content and almost all had multiple
      methodological limitations, making it difficult to draw conclusions about the value of these
      interventions. Perhaps the most comprehensive review of psychological studies in IBD, which
      included 16 studies, concluded that while psychological interventions can make a positive
      contribution to best practice multidisciplinary IBD treatment, well designed studies are
      needed to determine the efficacy of different treatments.

      We aim to conduct a multicenter randomised controlled trial to determine the efficacy of
      Acceptance and Commitment Therapy (ACT) on the psychological wellbeing of IBD patients.

      We aim to include 80 patients in this longitudinal study (40 in each arm). IBD patients
      attending St Vincent's University Hospital and Beaumont Hospital are treated in protocol
      driven inflammatory bowel disease clinics with therapy adhering to international treatment
      guidelines. We currently use protocols developed by the European Crohn's and Colitis
      Organisation (ECCO) and American Gastroenterology Association (AGA). Our care incorporates
      formalised multidisciplinary teamwork with standardised clinical monitoring, use of
      contemporary biomarkers of disease activity and a full range of current therapies including
      5-ASA and steroid medications, immunological therapies, open and laparoscopic surgery as
      appropriate, endoscopic treatment as necessary and the latest biological agents as per
      protocol. Thus, the study will take place in a clinical environment in which we adhere to the
      most modern practices.

      Initial assessment

        1. Biological assessment

           The initial assessment will comprise standardised and validated questionnaires to
           determine biological status. Specifically, we will assess:

           Demographic data Region, urban/rural, race, age, education, martial status, family
           history, occupation, employment status, smoking and alcohol history Nutritional status
           Body Mass Index Exercise status Godin Leisure-Time Exercise Questionnaire IBD history
           Disease type, duration, clinical, therapeutic and surgical history, Hospital admissions
           and visits, GP visits Disease activity Harvey Bradshaw Index (CD), Mayo Score (UC),
           physical examination Medication adherence Medication Adherence Report Scale 5 (MARS5)
           Laboratory indices Biochemical, immunological and haematological variables, faecal
           calprotectin, hair cortisol

        2. Psychological assessment

      This will include validated instruments to build a structured picture of the IBD illness. We
      will assess:

      General Quality of Life Short Form 12, Healthy days IBD specific QOL Short Health Scale
      Stress/anxiety/depression Depression Anxiety Stress Scales (DASS) 21 and Stress Thermometer
      Self Esteem Rosenberg Self Esteem Survey Body Image Modified Hopwood Body Image Scale Disease
      acceptance Acceptance and Action Questionnaire - Revised

      Interventions Group 1) Control (n=40) The control group will consist of 40 patients who will
      who will not receive treatment for 26 weeks and will then receive the ACT program.

      Group 2) Acceptance and Commitment therapy (n=40) ACT is a behavioural therapeutic approach
      that uses processes of acceptance, mindfulness, commitment and behaviour change to increase
      psychological flexibility. In terms of ACT for IBS specifically, its use is in guiding
      patients to develop a willingness to come in contact with their unpleasant experiences of
      physical symptoms and with the feeling of embarrassment, anticipatory anxiety and distressing
      thoughts commonly associated with IBS. The former agenda of trying to eliminate symptoms and
      distressing cognitive and emotional states can then be replaced by an agenda focusing on
      creating a more meaningful life with IBS.

      Assessments during intervention period Weekly assessments will be performed during the
      intervention period. These will include the Harvey Bradshaw Index (CD), Mayo Score (UC),
      Short Health Scale, (DASS) 21 and Stress Thermometer

      Eight week assessment

        1. Biological assessment Medication adherence Medication Adherence Report Scale 5 (MARS5)
           Nutritional status Body Mass Index Exercise status Godin Leisure-Time Exercise
           Questionnaire Disease activity indices Harvey Bradshaw Index (CD), Mayo Score (UC)
           Laboratory indices Biochemical, immunological and haematological variables, faecal
           calprotectin, hair cortisol

        2. Psychological assessment General Quality of Life Short Form 12, Healthy days IBD
           specific QOL Short Health Scale Anxiety/Depression Beck Depression Inventory, Beck
           Anxiety Inventory Stress Depression Anxiety Stress Scales (DASS) 21 and Stress
           Thermometer Self Esteem Rosenberg Self Esteem Survey Body Image Modified Hopwood Body
           Image Scale Sexuality Modified Golombok-Rust Inventory Disease acceptance Acceptance and
           Action Questionnaire - Revised

      26 week assessment Repeat of 8 week assessment

      Hair Cortisol Measurement The effects of stress are mediated by the stress hormone cortisol.
      Cortisol is involved in the regulation of glucose and lipid metabolism, body composition, and
      the immune system. Cortisol is traditionally measured in serum or saliva. However, because
      cortisol is secreted in a circadian rhythm and with pulses, the timing of sample collection
      is crucial when measuring cortisol in serum or saliva. In addition, cortisol is a stress
      hormone, and acute stress, such as that caused by the research setting or venepuncture, will
      influence measurements. A single measurement of cortisol in serum or saliva therefore poorly
      reflects medium and long-term cortisol levels. An alternative method to measure cortisol is
      in scalp hair. This method offers long-term measurements of cortisol levels, with 1cm of hair
      representing cortisol levels of approximately one month. In the last few years, the
      measurement of cortisol in scalp hair has been well validated. We will measure hair cortisol
      at the initial assessment, at the conclusion of therapy (8 weeks) and at the 26 week visit.
    

Intervention name(s): Acceptance and Committment Therapy (ACT)
Intervention type(s): Behavioral
Intervention description(s): This intervention will run with 12-15 participants in each group for a duration of 8 weeks. Each group session will last 1-1.5 hours.
Other intervention name(s): ACT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: IBD; Crohn's disease; ulcerative colitis; ACT