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

A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426568

Enrollment

Registered

2011-08-31

Start date

2011-01-31

Completion date

2013-05-31

Last updated

2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress

Brief summary

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.

Interventions

BEHAVIORALMulti-Convergent Therapy

Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire	Assessed at baseline and at 4 months, 8 months, and 1 year

Secondary

Measure	Time frame
Change in Levenstein Perceived Stress Score	2 monthly intervals over 1 year
Change in Hospital Anxiety and Depression Score	2 monthly intervals over 1 year
Change in Irritable Bowel Syndrome Symptom Severity Score	Assessed at baseline and at 4 months, 8 months, and 1 year
Relapse rate in inflammatory bowel disease	1 year
Feasibility of Treatment	4 months
Abdominal Symptoms Global Improvement Score	4 monthly intervals over 1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026