The effect of mindfulness-based cognitive therapy on reducing anxiety, depression and improving the mindfulness and quality of life among patients with asthma
Determining the effectiveness of Mindfulness based cognitive therapy in group style on anxiety, depression, mindfulness and quality of life in asthmatic patients.
Design
First, a questionnaire was given to the asthmatic patients (300) who referred to the office. 40 person of them had high scores in the abovementioned questionnaires, of which 30 were willing to participate in the study and six people dropped. 12 persons participated in both control the group and experimental group. No clinical trial and blindness was conducted in the control group.
Settings and conduct
The questionnaires were collected from the lung specialist's office and 8 sessions of group work were conducted at the counseling center
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from asthma according to the diagnosis of a specialist -reading and writing skills- willingness to participate in research and high scores in the Beck anxiety and depression inventory and low scores in quality of life and mindfulness
Intervention groups
The intervention group completed eight sessions of the Mindfulness course in two months (one and half an hour session per week). Written exercises and audio files of each session were delivered to pregnant mothers at the end of each session. Mindfulness training was performed according to the protocol of treatment. The therapists reviewed and resolved the homework problems of each pregnant mother. After training, the therapists reviewed the practicing of all of the participants and corrected the probable defects. Each session was finished by a review of what was going on at the session, as well as summarizing the content of the session and determining homework assignments.
Main outcome variables
The consequences are reducing depression and anxiety scores and raising the quality of life of asthma and mindfulness in asthmatic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034471N1
Registration date:2018-03-21, 1397/01/01
Registration timing:retrospective
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 507 9300
Email address
far.khanpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-07-11, 1396/04/20
Actual recruitment start date
2016-07-13, 1395/04/23
Actual recruitment end date
2017-09-09, 1396/06/18
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive therapy on reducing anxiety, depression and improving the mindfulness and quality of life among patients with asthma
Public title
The effect of mindfulness on anxiety, depression and improving the mindfulness and quality of life for asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing skills
Having asthma by the diagnosis of allergy specialist
willingness to participate in the research –
High scores in anxiety-depression questionnaire - quality of life and low score in mindfulness
High scores in anxiety, depression, and quality of life questionnaire and low score in mindfulness questionnaire
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pastaran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2016-12-04, 1395/09/14
Ethics committee reference number
IR.MUK.IRC.1394.170
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Depression
ICD-10 code
F33.8
ICD-10 code description
Other recurrent depressive disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention-After the intervention
Method of measurement
questionnaire
2
Description
Depression
Timepoint
Before intervention- After the intervention
Method of measurement
questionnaire
3
Description
quality of life
Timepoint
Before intervention- After the intervention
Method of measurement
questionnaire
4
Description
mindfulness
Timepoint
Before intervention- After the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8th session of the MINDFULNESS Workshop
Category
Behavior
2
Description
Control group: Not attending the workshop 8 Mindfulness Sessions
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Asthma and Allergy Dr. Rasoul Nasiri Kalmarzai
Full name of responsible person
Farzaneh khanpour
Street address
Pastaran
City
Sanandaj
Province
Kurdistan
Postal code
6618676341
Phone
+98 87 3324 0258
Email
far.khanpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Doctor Farzin Rezai
Street address
Pastaran - Kurdistan University of Medical Sciences - Vice Chancellor for Research
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3371 7085
Fax
+98 87 3366 0092
Email
x.moloudi@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Grant name
General
Grant code / Reference number
1394/170
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
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
Sanandaj University of Medical Sciences
Full name of responsible person
farzaneh khanpour
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
pastaran- Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6618676341
Phone
+98 87 3324 0258
Email
far.khanpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
farzaneg khanpour
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
pastaran-Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6618676341
Phone
+98 87 3324 0258
Email
f.khanpour@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
farzaneh khanpour
Position
31/5000 Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
pastaran - Kurdistan University of Medical Sciences
City
sananaj
Province
Kurdistan
Postal code
6618676341
Phone
+98 87 3324 0258
Email
f.khanpour@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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