A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01426568
• Date of registration: 26/08/2011
• Prospective Registration: No
• Primary sponsor: Cardiff and Vale University Health Board
• Public title: A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
• Scientific title: A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
• Date of first enrolment: January 2011
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01426568
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Inflammatory Bowel Disease

- Clinical Remission of inflammatory bowel disease as defined by an adapted disease
activity index and a CRP <10

- Age 18 to 65 years

- Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress
level (Levenstein perceived stress score > 0.44)

Exclusion Criteria:

- Use of steroids within 1 month of entry to study

- Initiation or change in dose of medication within 1 month of entry to the study

- Presence of ileostomy or colostomy

- Diagnosis of dementia or cognitive impairment

- Current psychosis or substance misuse

- Change in psychotropic medication in 3 months prior to entry to study

- Previous psychological interventions

- Pregnancy



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Intervention(s)

Behavioral: Multi-Convergent Therapy

Primary Outcome(s)

Change in Quality of Life in Inflammatory Bowel Disease Questionnaire [Time Frame: Assessed at baseline and at 4 months, 8 months, and 1 year]

Secondary Outcome(s)

Change in Hospital Anxiety and Depression Score [Time Frame: 2 monthly intervals over 1 year]

Change in Irritable Bowel Syndrome Symptom Severity Score [Time Frame: Assessed at baseline and at 4 months, 8 months, and 1 year]

Feasibility of Treatment [Time Frame: 4 months]

Relapse rate in inflammatory bowel disease [Time Frame: 1 year]

Change in Levenstein Perceived Stress Score [Time Frame: 2 monthly intervals over 1 year]

Abdominal Symptoms Global Improvement Score [Time Frame: 4 monthly intervals over 1 year]

Secondary ID(s)

10-CMC-4876

Source(s) of Monetary Support

Please refer to primary and secondary sponsors