Multicentre trial of combined cognitive behavioural therapy and antidepressant treatment in functional bowel disorders

Completed

• Conditions: Functional bowel disorders; Digestive System; Bowel disorders

• Registration Number: ISRCTN63671932
• Lead Sponsor: The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Literate, female patients aged 18 to 65 years
2. Symptoms present at least two days per week for greater than six months
3. Diagnosis of painful functional bowel disorder (later subcategorised using Rome II Criteria as irritable bowel syndrome [IBS], functional abdominal pain syndrome, painful constipation or unspecified functional bowel disorder [FBD])
4. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) that we developed. SFBD is defined as a score more than 110, and MFBD as a score between 36 and 110. Patients with mild symptoms (less than 36) will be excluded, since the proposed treatments would not be cost-effective nor clinically needed.

Exclusion Criteria

1. No evidence for lactose intolerance explaining the symptoms
2. Absence of heart disease, cardiac arrhythmias, glaucoma, urinary retention, pregnancy, alcohol consumption more than 3 oz/day that would preclude participation or prevent data assessment, or systemic or gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology (active thyroid disease, scleroderma, vasculitis, IBD, ischaemic bowel, gastrointestinal bypass or resection, malabsorption syndromes)
3. No history of bipolar disorder requiring hospitalisation, schizophrenia, substance abuse/dependency, or suicide attempts. Other psychiatric disorders may be excluded if they preclude successful participation in the study.
4. Ability and willingness to discontinue anticholinergic medication, calcium channel blockers or 5-hydroxytryptamine (5HT) receptor acting agents for the duration of the study
5. Discontinuance of all antidepressant medications for at least one month
6. Patients who have previously used Desipramine for more than one week
7. Use of an acceptable method of birth control (birth control pill, condoms, foam and barrier, intrauterine device [IUD], sterilisation) throughout the study (if receiving anti- depressant treatment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified