To evaluate the effect of cognitive behavioral therapy on behavioral responses and anxiety for patients with irritable bowel syndrome.
Design
Quasi-experimental design, two groups pre-test/ post-test, intervention and control group with blind randomization
Settings and conduct
The study will be carried out at Al Shatra General Hospital.
Participants/Inclusion and exclusion criteria
Patients with irritable bowel syndrome
Intervention groups
investigate effect of cognitive behavioral therapy sessions on behavioral responses and anxiety for IBS patients.
Main outcome variables
In this study the instruments that will be use are scales used in cognitive behavioral therapy for irritable bowel syndrome that presented below:
1. The Visceral Sensitivity Index is a unidimensional 15- item scale that measures gastrointestinal symptom–specific anxiety (e.g., “I often fear that I will not be able to have normal bowel movements”).
2. The Irritable Bowel Syndrome-Behavioral Responses Questionnaire includes 26 items with responses ranging from 1 (never) to 7 (always), and its total score ranges from 26 to 182.
to investigate the effect of cognitive behavioral therapy on behavioral responses and anxiety for patients with irritable bowel syndrome.
General information
Reason for update
Acronym
CBT (Cognitive behavioral therapy)
IRCT registration information
IRCT registration number:IRCT20240529061950N1
Registration date:2024-11-03, 1403/08/13
Registration timing:registered_while_recruiting
Last update:2024-11-03, 1403/08/13
Update count:0
Registration date
2024-11-03, 1403/08/13
Registrant information
Name
Mustafa R. Waheed
Name of organization / entity
University of Baghdad college of Nursing
Country
Iraq
Phone
+964 783 007 2313
Email address
mustafa.alhelali313@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-15, 1403/07/24
Expected recruitment end date
2025-02-15, 1403/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cognitive behavioral therapy (CBT) on behavioral responses and anxiety for patients with irritable bowel syndrome (IBS)
Public title
Cognitive behavioral therapy for patients with Irritable Bowel Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
An adult patients with underlying IBS.
Fulfillment of Rome III criteria for IBS
Male and female patients
patients who accepted to participate in the CBT
Exclusion criteria:
Blood in stool without benign medical explanation
Rapid weight loss without benign medical explanation
Ongoing alcohol or drug abuse
Patients with colon cancer or Inflammatory Bowel diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is simple randomization method and the tools used in randomization is computer software.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants in the study do not know (blinds) whether they are in the intervention group or the control group. Only the researcher, who is himself a provider of cognitive behavioral therapy, is the one who knows that.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baghdad University /college of Nursing
Street address
al adil street
City
Al shatra
Postal code
313
Approval date
2024-09-22, 1403/07/01
Ethics committee reference number
Session 8
Health conditions studied
1
Description of health condition studied
patients with irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
behavioral responses and anxiety, the primary outcomes: Changes in behavioral responses and anxiety levels, measured using validated anxiety scales and behavioral assessment tools.
Timepoint
before intervention and 8 weeks after intervention.
Method of measurement
1. The Visceral Sensitivity Index is a unidimensional 15- item scale that measures gastrointestinal symptom–specific anxiety (e.g., “I often fear that I will not be able to have normal bowel movements”). 2. The Irritable Bowel Syndrome-Behavioral Responses Questionnaire includes 26 items with responses ranging from 1 (never) to 7 (always), and its total score ranges from 26 to 182.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Intervention Name: Cognitive Behavioral Therapy (CBT). Details: Treatment Method: Psychological therapy. Procedures: Includes cognitive restructuring, stress management, relaxation exercises, and exposure therapy. Number of Sessions: 4 sessions Content: Each session will cover cognitive restructuring, stress management, relaxation techniques, and graded exposure exercises tailored to IBS. Duration of Sessions: Each session will last for 45 minutes. Frequency: once weekly. Method of Use: Conducted by licensed therapist face-to-face interview. Duration of Intervention: 4 weeks. Control Group: Intervention Name: Standard Care / Placebo. Details: Treatment Method: Usual care without any additional psychological therapy. Procedures: Regular follow-up visits with the primary care provider or gastroenterologist. Number of Sessions: As per the usual care. schedule Content: Standard medical treatment for IBS, which may include dietary advice, medication management, and regular monitoring of symptoms. Duration of Sessions: Typically 30 minutes, depending on the care provider. Frequency: As recommended by the primary care provider. Method of Use: In-person visits with medical professionals
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Shatra General Hospital
Full name of responsible person
Mustafa alhelali
Street address
Al Adil street
City
Al Shatra
Postal code
313
Phone
+964 780 076 0535
Email
mustafa.alhelali313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
College of Nursing
Street address
Al Adil street
City
Al Shatra
Postal code
313
Phone
+964 780 076 0535
Email
mustafa.alhelali313@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal Finance
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
University of Baghdad, college of Nursing
Full name of responsible person
Mustafa R. Waheed Alhelali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Al Adil street
City
Al Shatra
Province
Thiqar
Postal code
313
Phone
+964 780 076 0535
Email
mustafa.alhelali313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad, college of Nursing
Full name of responsible person
Mustafa R. Waheed Alhelali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Al Adil street
City
Al Shatra
Province
Thiqar
Postal code
313
Phone
+964 780 076 0535
Email
mustafa.alhelali313@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, college of Nursing
Full name of responsible person
Mustafa R. Waheed Alhelali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Al Adil street
City
Al Shatra
Province
Thiqar
Postal code
313
Phone
+964 780 076 0535
Email
mustafa.alhelali313@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To preserve patients privacy and adhere to the terms of the Ethics Committee
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available