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A comparison of the effectiveness of cognitive-behavioral stress management and optimism training on psychological adjustment, immunological markers and somatic symptoms in female Ulcerative Colitis patients

Protocol summary

Summary
The aim of this study was comparison of cognitive-behavioral stress management and optimism training on psychological adjustment, immunological markers and somatic symptoms in female Ulcerative Colitis patients. Statistical population of this project were the whole female Ulcerative Colitis patients, that referred to Noor Medical center and private gastrointestinal clinic. Among this patients, 60 patients, based on histological, endoscopic and radiologic criteria, diagnosed Ulcerative Colitis and were between 18-65 years old, at least diploma that inclined to participation in the project, were selected randomly. These patients were assigned in 3 groups, by random. First group exposed to cognitive-behavioral stress management plus common medical treatment, second group exposed to optimism training plus common medical treatment, and third group exposed to common medical treatment, only. Two interventional groups, exposed to 8 week cognitive-behavioral stress management or optimism training. Every groups, pre and post intervention completed psychological inventories and somatic symptoms and blood samples, too. Inventories and blood samples was compared among groups, then.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011295278N1
Registration date: 2011-07-21, 1390/04/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-21, 1390/04/30
Registrant information
Name
Marzieh sadat Sajadinejad
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 86 6322 6156
Email address
zsajadi@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science , Behavioral Medicine Researche Center
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-05-20, 1390/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness of cognitive-behavioral stress management and optimism training on psychological adjustment, immunological markers and somatic symptoms in female Ulcerative Colitis patients
Public title
efectiveness of psychological intervention on ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: diagnosis of ulcerative colitis based on gastroentrologist,s idea and endoscopic, histologic and raidiologic criteria; age between 18-65; minimal education level on dyploma; nonconsumption psychiatric drugs or no participation in psychological intervention on past 6 mounth; satisfaction about participation in this project exclusion criteria: age less 18 or more 65 yaers old; consumption psychiatric drugs or participation in psychological intervention on past 6 mounth; education level under dyploma; no satisfaction about participation in this project
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Isfahan University of Medical Science,Hezarjarib Avenue, Isfahan
City
Isfahan
Postal code
81745-319
Approval date
2011-01-31, 1389/11/11
Ethics committee reference number
12/4/115943/پ

Health conditions studied

1

Description of health condition studied
ulcerative colitis
ICD-10 code
k51.9
ICD-10 code description
postprocedural disorders of digestive system

Primary outcomes

1

Description
psychological adjustment
Timepoint
pretreatment, post treatment and 6 mounth next
Method of measurement
Hospital Anxiety and Depression Scale, Precived Stress Scale, Coping Strategies Inventory

Secondary outcomes

1

Description
somatic symptom
Timepoint
pretrreatment, post treatment and 6 mounth next
Method of measurement
physician idea, Lichtiger colitis activity index (CAI)

2

Description
IL6,IL10,TNF,INF,Cortisol
Timepoint
pretrreatment, post treatment and 6 mounth next
Method of measurement
blood sample

Intervention groups

1

Description
in intervention group: cognitive-behavioral stress management
Category
Behavior

2

Description
in intervention group: optimism training
Category
Behavior

3

Description
in control group: common medical treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
private gastroentrologist clinic
Full name of responsible person
Peyman Adibi
Street address
Mohtasham Kashani street, Isfahan
City
Isfahan

2

Recruitment center
Name of recruitment center
Noor Medical Center
Full name of responsible person
Reza Bagherian
Street address
Noor Medical Center, Ostandari Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behavioral Sciences Research Centre,Isfahan University Medical Science
Full name of responsible person
Reza Bagherian
Street address
Noor Medical Centre, Ostandari Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioral Sciences Research Centre,Isfahan University Medical Science
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
University of Isfahan
Full name of responsible person
Marzieh sadat Sajadinejad
Position
student
Other areas of specialty/work
Street address
Education Science Faculty,University of Isfahan , Hezarjarib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 918 965 6608
Fax
Email
zsajadi@edu.ui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of isfahan
Full name of responsible person
Karim Asgari
Position
Assistant professor
Other areas of specialty/work
Street address
Education Science Faculty, University of Isfahan, Hezarjarib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 913 167 1710
Fax
Email
k.asgari@edu.ui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Marzieh sadat Sajadinejad
Position
student
Other areas of specialty/work
Street address
Education Science Faculty, University of Isfahan, Hezarjarib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 918 965 6608
Fax
Email
zsajadi@edu.ui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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