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

ISRCTN	ISRCTN63671932
DOI	https://doi.org/10.1186/ISRCTN63671932
Protocol serial number	MCT-63138
Sponsor	The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63138)

Submission date: 30/01/2007
Registration date: 30/01/2007
Last edited: 17/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brenda B Toner
Scientific

Social Equity & Health Research
Centre for Addiction & Mental Health
455 Spadina Ave, Suite 300
Toronto, Ontario
M5S 2G8
Canada

Phone	+1 416 535 8501 ext. 7607
Email	brenda_toner@camh.net

Study information

Primary study design	Interventional
Study design	Randomised parallel three arm trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cognitive behavioural therapy and antidepressant treatment in functional bowel disorders: a multicentre randomised, parallel, three arm trial studying behavioural and medication impact
Study objectives	Combination therapy (cognitive behavioural therapy [CBT] plus desipramine) is superior to monotherapy (CBT or desipramine) for functional bowel disorders in women.
Ethics approval(s)	Centre for Addiction and Mental Health Research Ethics Board (CAMH REB), Toronto Academic Health Sciences Council (TAHSC) (Canada) approved on the 7th March 2006
Health condition(s) or problem(s) studied	Functional bowel disorders
Intervention	Group 1: cognitive behaviour therapy (CBT), once a week for 12 weeks Group 2: desipramine, up to 150 mg/day for 12 weeks Group 3: combined CBT plus desipramine: CBT once a week and desipramine administered weekly up to 150 mg/day for 12 weeks Contact for public queries: Adrienne Amato Research Co-ordinator Social Equity & Health Research Centre for Addiction & Mental Health 455 Spadina Ave, Suite 300 Toronto, Ontario M5S 2G8 Canada Tel: +1 416 979 4296 Fax: +1 416 979 6811 Email: adrienne_amato@camh.net
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Desipramine
Primary outcome measure(s)	Composite measure consisting of: 1. Satisfaction with treatment 2. Global well being 3. Pain ratings 4. Health related quality of life Points two to four above will be measured at pre-treatment, post-treatment, three month follow up and six month follow up.
Key secondary outcome measure(s)	Four outcomes of composite measure will be analysed separately as secondary variables: 1. Satisfaction with treatment: post-treatment, three month follow up, six month follow up 2. Global well being: pre-treatment, post-treatment, three month follow up, six month follow up 3. Pain ratings: pre-treatment, end of treatment, three month follow up, six month follow up 4. Health related quality of life: post-treatment, three month follow up, six month follow up
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	200
Key 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.
Key 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)
Date of first enrolment	01/05/2006
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Canada

Study participating centre

Social Equity & Health Research

Toronto, Ontario
M5S 2G8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes