Multicentre trial of combined cognitive behavioural therapy and antidepressant treatment in functional bowel disorders
| ISRCTN | ISRCTN63671932 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63671932 |
| Secondary identifying numbers | 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
Not provided at time of registration
Contact information
Dr Brenda B Toner
Scientific
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 |
|---|---|
| brenda_toner@camh.net |
Study information
| Study design | Randomised parallel three arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.camh.net/Research/Studies_and_recruitment/functional_bowel_study.html |
| 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Desipramine |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2006 |
| Overall study end date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Participant 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. |
| Participant 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) |
| Recruitment start date | 01/05/2006 |
| Recruitment end date | 31/05/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Social Equity & Health Research
Toronto, Ontario
M5S 2G8
Canada
M5S 2G8
Canada
Sponsor information
The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)
Hospital/treatment centre
Hospital/treatment centre
33 Russell Street
Toronto
Ontario
M5S 2S1
Canada
| Website | http://www.camh.net/ |
|---|---|
"ROR" |
https://ror.org/03e71c577 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63138)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
