The effectiveness of Cognitive Behavioral Therapy (CBT), Hypnotherapy and drug Therapy on Symptoms Intensity, Quality of Life, Self-focused Attention and Rumination- Reflection in Patients with Irritable Bowel Syndrome
the present study was conducted to formulate individual treatment protocols of hypnotherapy and cognitive behavioral therapy in patients with irritable bowel syndrome and examine their effectiveness in the severity of IBS symptoms, quality of life, Self-focused attention and rumination in patients with IBS and compare the effectiveness of these two treatments in improving the above-mentioned variables.
Design
controlled clinical trial, parallel group, not blinded, randomized
Settings and conduct
The present study is with pre-test, post-test and follow-up and not blinded research. The samples include 48 patients referred to Tehran Gastroenterology Clinics. The samples were randomly divided into three group of cognitive-behavioral therapy hypnotherapy and control group. In addition to drug therapy, the intervention groups were treated individually and separately during cognitive-behavioral and hypnotherapy treatments at 1 hour and half session during eight weeks, and the control group were only received the drug treatment
Participants/Inclusion and exclusion criteria
age between 20 to 50, degree of diploma, no history of mental illness, lack of any warning physical signs such as unusual weight loss, rectal bleeding, family history of colon cancer
Intervention groups
cognitive-behavioral therapy, hypnotherapy and control group
Main outcome variables
severity of IBS symptoms, quality of life, Self-focused attention and rumination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042437N1
Registration date:2019-02-23, 1397/12/04
Registration timing:retrospective
Last update:2019-02-23, 1397/12/04
Update count:0
Registration date
2019-02-23, 1397/12/04
Registrant information
Name
Negar Fouladi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4243 3342
Email address
nfouladi1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
2018-01-20, 1396/10/30
Actual recruitment end date
2018-07-21, 1397/04/30
Trial completion date
2018-07-21, 1397/04/30
Scientific title
The effectiveness of Cognitive Behavioral Therapy (CBT), Hypnotherapy and drug Therapy on Symptoms Intensity, Quality of Life, Self-focused Attention and Rumination- Reflection in Patients with Irritable Bowel Syndrome
Public title
The effectiveness of Cognitive Behavioral Therapy (CBT) and Hypnotherapy on Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 50
degree of diploma
no history of mental illness
lack of any warning physical signs such as unusual weight loss, rectal bleeding
family history of colon cancer
Exclusion criteria:
having symptoms such as gastrointestinal bleeding, melena, fever, weight loss of 10 percent during the past six months.
having a history of cancer of colon in the family.
having a severe psychiatric disease.
lack of willingness to participate in the plan.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
1
patients who were referred to Gastroenterology Clinic in Tehran
Actual sample size reached:
48
More than 1 sample in each individual
Actual sample size in each individual:
1
patients who were referred to Gastroenterology Clinic in Tehran
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomized using simple randomization to ensure equal group sizes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University, Science and Research Branch
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.IAU.SRB.REC.1396.76
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 symptoms
Timepoint
pre-test, a post-test and 3 months of follow up
Method of measurement
irritable bowel syndrome severity scoring system Questionnaire
2
Description
Irritable bowel syndrome quality of life
Timepoint
pre-test, a post-test and 3 months of follow up
Method of measurement
irritable bowel syndrome quality of life Questionnaire
3
Description
focus of attention
Timepoint
pre-test, a post-test and 3 months of follow up
Method of measurement
focus of attention questionnaire
4
Description
rumination
Timepoint
pre-test, a post-test and 3 months of follow up
Method of measurement
rumination questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive Behavior Therapy
Category
Treatment - Other
2
Description
Intervention group: hypnotherapy
Category
Treatment - Other
3
Description
Control group: only drug therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Gastroenterology Clinics
Full name of responsible person
Negar Fouladi
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
3919715179
Phone
+98 86 4243 3342
Email
nfouladi1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Anoosh Eghdami
Street address
Shahid Fahmideh Blvd., Shahid Beheshti Blvd
City
Saveh
Province
Markazi
Postal code
3919715179
Phone
+98 86 4243 3342
Email
alielyasi15@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negar Fouladi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Fahmideh Blvd., Shahid Beheshti Blvd
City
Saveh
Province
Markazi
Postal code
3919715179
Phone
+98 86 4243 3342
Email
nfouladi1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negar Fouladi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Fahmideh Blvd., Shahid Beheshti Blvd
City
Saveh
Province
Markazi
Postal code
3919715179
Phone
+98 86 4243 3342
Email
nfouladi1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negar Fouladi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Fahmideh Blvd., Shahid Beheshti Blvd
City
Saveh
Province
Markazi
Postal code
3919715179
Phone
+98 86 4243 3342
Email
nfouladi1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publish as an article
When the data will become available and for how long
Publish as an article
To whom data/document is available
Publish as an article
Under which criteria data/document could be used
Publish as an article
From where data/document is obtainable
Publish as an article
What processes are involved for a request to access data/document