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Development of Lifestyle educational Package and Comparing its Effectiveness with Mindfulness-Based Cognitive Therapy on Disease Activity and Related Psychological Variables in Patients with Ulcerative Colitis

Protocol summary

Study aim
The purpose of this study is to develop of Lifestyle educational package and comparing its effectiveness with mindfulness-based cognitive therapy on disease activity and related psychological variables in patients with ulcerative colitis
Design
Clinical trial with control group, lifestyle, cmindfulness based cognitive therapy, simple randomized
Settings and conduct
50 UC patients who have been enrolled in the Isfahan Liver and Gastroenterology Research Center are selected based on entry criteria and are randomly assigned into 3 groups. The two intervention groups undergo life-style education (1 group) and mindfulness based cognitive therapy (2 group) and control group under an individual training session. Psychological evaluation is performed in three stages
Participants/Inclusion and exclusion criteria
Entry Criteria: Diagnosis of Ulcerative Colitis, Conscious Consent to Participate in Research, Physical and mental ability to participate in interview or intervention, The level of education at least the end of the elementary school period, The age range of between 18-70 years old, Call number to invite to participating in intervention, Resident of the city. Exit criteria: The acute phase of psychiatric disorders (such as bipolar disorder, severe depression), Participating in counseling or psychotherapy sessions during the last 6 months, Lack of motivation to participate in the interview and the ability to express thoughts and feelings, Unwillingness to continue to participating in intervention
Intervention groups
Group 1. the education of Lifestyle Group 2. the education of mindfulness based cognitive therapy Group 3.on the waiting list: An individual counseling session during interventions
Main outcome variables
Severity of fatigue, disease activity, self-care agency, anxiety, depression, quality of life, illness perception, perceived stress, and disease- related worries and concerns

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180520039736N1
Registration date: 2018-06-13, 1397/03/23
Registration timing: retrospective

Last update: 2018-06-13, 1397/03/23
Update count: 0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Mina Mazaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3446 2271
Email address
mina.mazaheri@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-24, 1396/03/03
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of Lifestyle educational Package and Comparing its Effectiveness with Mindfulness-Based Cognitive Therapy on Disease Activity and Related Psychological Variables in Patients with Ulcerative Colitis
Public title
Development of Lifestyle educational Package and survey its Effectiveness in Patients with Ulcerative Colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Ulcerative Colitis Conscious Consent to Participate in Research Physical and mental ability to participate in interview or intervention The level of education at least the end of the elementary school period The age range of between 18-70 years old Call number to invite to participating in intervention Resident of the city
Exclusion criteria:
The acute phase of psychiatric disorders (such as bipolar disorder, severe depression) Participating in counseling or psychotherapy sessions during the last 6 months Lack of motivation to participate in the interview and the ability to express thoughts and feelings Unwillingness to continue to participating in intervention
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
randomized simple
Blinding (investigator's opinion)
Not blinded
Blinding description
Participants, Data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
survey of the validity of developed Lifestyle educational Package through a nested design(qualitative approach)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan Azad University, Isfahan (Khorasgan) Branch
Street address
Daneshgah Bolvar, Arghavaniye, Sharghi Jey Ave, Isfahan Azad University (Khorasgan), Isfahan
City
Isfahan
Province
Isfehan
Postal code
8148617961
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.IAU.KHUISF.REC.1397-28

Health conditions studied

1

Description of health condition studied
Ulcerative Colitic
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
disease activity
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Lichtiger Colitis Activity Index

2

Description
Fatigue Severity
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Fatigue Severity Scale

3

Description
Self-Care Agency
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Exercise of Self-Care Agency Scale

4

Description
Anxiety
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Hospital Anxiety Depresion Scale

5

Description
Depresion
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Hospital Anxiety Depresion Scale

6

Description
quality of life
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Crohn’s and Ulcerative Colitis Questionnaire

7

Description
Perceived stress
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Perceived stress scale

8

Description
Illness Perception
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
Brief-Illness Perception Questionnaire

9

Description
disease related Concerns
Timepoint
Before the intervention, after the intervention, three months after the end of the intervention
Method of measurement
The Rating Form of Inflammatory Bowel Disease Patient Concerns

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The education of discovered Lifestyle educational Package
Category
Lifestyle

2

Description
Intervention group: The education of Mindfulness-Based Cognitive Therapy
Category
Treatment - Other

3

Description
Control group: Individual counseling in a session
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Liver and Digestive Research Center
Full name of responsible person
Dr. Hamed Daghaghzadeh
Street address
No. 222, Hakimnezami Ave., Daghighi crossroad, Shariati St., Opposite Sepahan Syman Company
City
Isfahan
Province
Isfehan
Postal code
8173948763
Phone
+98 31 3626 0709
Email
Daghagh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Researcher: Mina Mazaheri Tehrani
Street address
Daneshgah Bolvar, Arghavaniye, Sharghi Jey Ave, Isfahan Azad University, Isfahan (Khorasgan) Branch
City
Isfahan
Province
Isfehan
Postal code
81595158
Phone
+98 31 3446 2271
Email
mina.mazaheri@mail.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Azad University, Isfahan (Khorasgan) Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Mazaheri Tehrani
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.6, deadlock 2, Abdulrazagh St., Takhti Crossroad, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173948763
Phone
+98 34462271
Email
mina.mazaheri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Isfahan (Khorasgan) Branch,
Full name of responsible person
Dr. Asghar Aghaei
Position
Professor of Department of Educational Science and Psychology, Isfahan (Khorasgan) Branch, Islamic
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah Bolvar, Arghavaniye, Sharghi Jey Ave, Isfahan Azad University, Isfahan (Khorasgan) Branch
City
Isfahan
Province
Isfehan
Postal code
81595158
Phone
+98 31 3535 4001
Email
aghaeipsy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Mazaheri Tehrani
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.6, deadlock 2, Abdulrazagh St., Takhti Crossroad, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173948763
Phone
+98 31 3466 2271
Email
mina.mazaheri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
The results of the research
When the data will become available and for how long
6 months after printing results
To whom data/document is available
For researchers who work in academic and scientific institutions
Under which criteria data/document could be used
To report the results in other research studies by maintaining its source
From where data/document is obtainable
mina.mazaheri@gmail.com
What processes are involved for a request to access data/document
Request by email
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