Objectives: This study aims at investigating the effectiveness of mindfulness-based cognitive therapy on asthma patient’s depression, anxiety, and somatic symptoms at Isfahan. Design: This is a pretest- post test experimental study. Methods: A sample of 30 asthma patients will be recruited. Patients will be randomly allocated to either the experimental or the control groups. The patients in the experimental group will receive mindfulness-based cognitive therapy while the patients in the control group will receive no intervention. Study instruments include the Beck Anxiety Inventory, the Beck Depression Inventory and Asthma Quality of Life Questionnaire. These instruments will be completed before, immediately after. Inclusion criteria: women that having an age of 18–55 years, education high school to up, and are patient for at least one year. Exclusion criteria: having any psychotic or somatic disorder and being absent for two session. Intervention: The intervention of this study is a mindfulness-based cognitive therapy which includes 8 two-hour sessions that hold weekly. Primary outcomes: The primary outcomes are depression, anxiety, and somatic symptom.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061622770N1
Registration date:2015-12-06, 1394/09/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-06, 1394/09/15
Registrant information
Name
ُُShaghayegh Kahrizi
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 913 108 7335
Email address
kahrizi-1364@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-11, 1394/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based cognitive therapy (MBCT) on depression, anxiety and somatic symptoms in asthma patients.
Public title
The effectiveness of mindfulness-based cognitive therapy (MBCT) on depression, anxiety and somatic symptoms in asthma patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having asthma at least one year; education high school to top; women age 18-55; medical treatment is ongoing
Exclusion criteria:having any psychotic or somatic disorder ; being absent for two session
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized be done by closed envelops method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shiraz University of Medical Sciences
Street address
Shiraz
City
Shiraz
Postal code
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.SUMS.REC.134
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma,unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Preintervention,Postintervention
Method of measurement
Beck Anxiety Invetory (BAI)
2
Description
Depression
Timepoint
Preintervention,Postintervention
Method of measurement
Beck Depression Inventory (BDI-II)
3
Description
Somatic Symptoms
Timepoint
Preintervention,Postintervention
Method of measurement
Asthma Quality of Life Questionnaire (AQLQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Minfulness -Based Cognitive Therapy(MBCT) is be done on intervention group for 8 session that takes 2 hour weekly.
Category
Behavior
2
Description
Control group: control group is placed on waiting list and not be received any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr ghasemi asthma clinic
Full name of responsible person
Dr.Ramin Ghasemi
Street address
block A; Ajhand center; Amadegah
City
Isfahan
2
Recruitment center
Name of recruitment center
Isabne Maryam hospital
Full name of responsible person
Dr.Ramin Ghasemi
Street address
Shamsabadi street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Shaghayegh Kahrizi
Street address
Padide apartment, north Esteghlal street, Mardavij
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Shiraz University
Full name of responsible person
Shaghayegh Kahrizi
Position
Clinical Psychology M.A
Other areas of specialty/work
Street address
Eram square
City
shiraz
Postal code
Phone
+98 913 108 7335
Fax
Email
kahrizi_1364@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Shaghayegh Kahrizi
Position
Clinical Psychology M.A
Other areas of specialty/work
Street address
Eram square
City
Shiraz
Postal code
Phone
+98 913 108 7335
Fax
Email
kahrizi_1364@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university
Full name of responsible person
Shaghayegh Kahrizi
Position
Clinical Psychology M.A
Other areas of specialty/work
Street address
Eram Square
City
shiraz
Postal code
Phone
+98 913 108 7335
Fax
Email
kahrizi_1364@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)