Efficacy of group method cognitive-behavioral stress management on reducing symptoms of patients with irritable bowel syndrome with and without co–morbidity of depression and anxiety and increase quality of life
In this double-blind clinical trial, 50 patients with irritable bowel syndrome (assuming 0.05 = α, 0.8 = β, 10.52 = σ, d = 7.5) were selected randomly from study population contains all patients referred to GI clinic of Yasouj after diagnosis by a gastroenterologist based on clinical interview and examination criteria Diagnosis of Rome III. These objects were randomly allocated to two groups: drug therapy combined with cognitive behavioral stress management training and drug therapy alone. During two months of educational sessions of cognitive behavioral stress management therapy, 8 sessions for each group were held (each session 2 hours). Then questionnaire included demographic data, test strategies to deal Carver et al (1989), Quality of Life questionnaire in patients with irritable bowel, Patrick and Drasman (1998), Holmes and Rahe scale and severity of intestinal symptoms (BSS-FS) and Beck Anxiety & depression Scale were collected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102195868N1
Registration date:2011-04-08, 1390/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-08, 1390/01/19
Registrant information
Name
Ali Kamkar
Name of organization / entity
Yasouj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1224 4035
Email address
kamkar.ali@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasouj University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of group method cognitive-behavioral stress management on reducing symptoms of patients with irritable bowel syndrome with and without co–morbidity of depression and anxiety and increase quality of life
Public title
Behavioural cognitive therapy of irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- diagnostic criteria for IBS based on Rome III criteria; 2- No psychological treatment during the past three months; 3- desire and satisfaction of participating in the plan. Exclusion criteria: 1- having symptoms such as gastrointestinal bleeding, melena, fever, weight loss of 10 percent during the past six months, and anemia; 2- having a history of cancer of colon in the family; 3- having a severe psychiatric disease; 4- lack of willingness to participate in the plan. 5-lack of being first-degree relatives or neighbours of patients.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasouj University of Medical Sciences
Street address
Centeral Building of Yasouj University of Medical Sciences, Motahari Blvd.
City
Yasouj
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
P/23/5/3465
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
k58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
severity of IBS symptoms
Timepoint
3 month
Method of measurement
scale rome III
2
Description
stress management
Timepoint
3 month
Method of measurement
Holmz & Rahe questionnaire & carver questionnaire
Secondary outcomes
1
Description
depression
Timepoint
3 months
Method of measurement
Beck depression scale
2
Description
anxiety
Timepoint
3 months
Method of measurement
Beck anxiety scale
3
Description
quality of life
Timepoint
3 months
Method of measurement
QOL-IBS questionnaire
Intervention groups
1
Description
Treatment group: behavioural cognitive therapy of stress management (8 sessions, each session 2 hours) and drug therapy
Category
Behavior
2
Description
control group: only drug therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic
Full name of responsible person
Street address
City
Yasouj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr.Mohammad Zoladl - University Research and Technology Deputy
Street address
Central Building of Yasouj University of Medical Sciences -Second Floor, Motahari Blvd.
City
Yasouj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Kamkar
Position
MS.PhD candidate/Financial Administrative Assistant of University
Other areas of specialty/work
Street address
Central Building of Yasouj University of Medical Sciences , Motahari Blvd.
City
Yasouj
Postal code
Phone
+98 74 1333 7253
Fax
Email
kamkar.ali@yums.ac.ir , kamkarali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Kamkar
Position
MS-PhD candidate
Other areas of specialty/work
Street address
Central Building of Yasouj University of Medical Sciences , Motahari Blvd.
City
Yasouj
Postal code
Phone
+98 74 1333 7253
Fax
Email
kamkar.ali@yums.ac.ir , kamkarali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Kamkar
Position
MS.PhD candidate/Financial Administrative Assistant of University
Other areas of specialty/work
Street address
Central Building of Yasouj University of Medical Sciences, Motahari Blvd.
City
Yasouj
Postal code
Phone
+98 74 1333 7253
Fax
Email
kamkar.ali@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)