ISRCTN63671932CompletedNot Applicable
Cognitive behavioural therapy and antidepressant treatment in functional bowel disorders: a multicentre randomised, parallel, three arm trial studying behavioural and medication impact
The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)0 sites200 target enrollmentStarted: January 30, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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)
Investigators
Similar Trials
Completed
Not Applicable
Depression Acceptance and Commitment Therapy in the ElderlyF41.2Recurrent depressive disorderMixed anxiety and depressive disorderDepressionF01.145.126.350RBR-4vsv5cniversidade de Pernambuco
Recruiting
Not Applicable
Optimizing cognitive behavioral therapy for depression management in psychiatric care studyMajor depressionJPRN-UMIN000043814Keio University School of Medicine100
Recruiting
Not Applicable
Effect of cognitive-behavioral therapy on depression and life expectancy of students with emotional failureEmotional failure.IRCT20170117032023N1Dezfoul University of Medical Sciences20
Completed
Not Applicable
Effect of Cognitive-Behavioral Therapy on depression,life expectancy,and adjustment in patients with Hepatitis B.-Cognitive-Behavioral Therapy Associated with Depression , life Expectancy And Compliance with Hepatitis B.IRCT2014082618937N1Islamic Azad University, Torbat-e-Jam28
Withdrawn
Not Applicable
Cognitive-behavioral therapy for depression in youthsDepressive disorderdysthimic disorderNL-OMON31391niversiteit Maastricht48