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

Cardiff and Vale University Health Board

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Behavioral: Multi-Convergent Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01426568

10-CMC-4876

Details and patient eligibility

About

The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Course of Multi-Convergent Thearpy

Active Comparator group

Treatment:

Behavioral: Multi-Convergent Therapy

Waiting List for Multi-Convergent Therapy

No Intervention group