Determination of the effectiveness of acceptance and commitment therapy on the symptom control, quality of life and mood status of asthmatic patients in Isfahan
Design
Two arms parallel-group randomized trial without blinding on 30 patients. The randomization will be done using Random Allocation software
Settings and conduct
The evaluation of acceptance and commitment therapy on the asthma symptoms, quality of life, and mood disorders will be assessed in asthmatic patients referring to Noor Center. The patients will fill the questionnaires at baseline, at the end of the intervention and within three months.
Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Over 18 years old
-Documented diagnosis of asthma based on response to bronchodilator
-Medical therapy for the least period of three months
-Adherence to medical therapy
Unmet criteria:
-The diagnosis of psychiatric disorders irrelevant to the underlying asthma
-Reluctance to participate in the study
Intervention groups
The intervention group: The asthmatic patients of this group will be trained about the acceptance and commitment therapy for 8 sessions, each endures for 90 minutes and also should administer their asthma-related medical therapies as well.
COntrol group: ،اهس لقخعح خب حشفهدفس شقث خدمغ فقثشفثی ئثیهزشممغ.
Main outcome variables
Asthma symptoms
Quality of life
Mood status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200512047411N1
Registration date:2020-06-16, 1399/03/27
Registration timing:retrospective
Last update:2020-06-16, 1399/03/27
Update count:0
Registration date
2020-06-16, 1399/03/27
Registrant information
Name
Mahin Rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 7707
Email address
mahin.rabiei1987@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-01-10, 1398/10/20
Actual recruitment start date
2019-10-12, 1398/07/20
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-04-05, 1399/01/17
Scientific title
Effectiveness of Acceptance and Commitment Group Therapy on control of symptoms, quality of life and mood state in Asthma patients in Isfahan
Public title
Effectiveness of Acceptance and Commitment Group Therapy on asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
Documented diagnosis of asthma based on response to bronchodilator
Medical therapy for the least period of three months
Adherence to the medical therapy
Exclusion criteria:
The diagnosis of psychiatric disorders irrelevent to the underlying asthma
Reluctance to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be performed through convenience sampling. Therefore, each of the patients will be provided with a particular number using random number table. If the number is even, the patient will be allocated to the intervention group and if odd to the control group.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.356
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma symptoms
Timepoint
At baseline, at the end of the intervention and within three months
Method of measurement
Asthma control questionnaire
2
Description
Quality of life
Timepoint
At baseline, at the end of the intervention and within three months
Method of measurement
Asthma Quality of life questionnaire
3
Description
mood status
Timepoint
At baseline, at the end of the intervention and within three months
Method of measurement
Hospital anxiety and depression scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Asthma medical therapy plus Acceptance and Commitment Therapy in which the patients will be trained Acceptance and Commitment Psychotherapy for eight sessions each consisted of 90 minutes plus asthma medication based on the Global Initiative for Asthma protocol in which the patients will be treated in 4 categories. The ACT consists of sessions, including 1) Primary introduction and introduction of mental abilities (thoughts, feelings, bodily senses, memories, and impulses); 2) the introduction of the control is the problem and the way of reaction to the problems; 3) teaching the difference between pain and suffering and increasing the psychological acceptance and willingness to thoughts and feelings; 4) Clarification of the values and goals and provision of a table in which the values are categorized; 5) teaching the concept of fusion to the mental products and exercises for defusion of the thoughts; 6) teaching the concept of self-conceptualization and how to face this concept; 7) the introduction of commitment and the values of performing purposeful activities; 8) conclusion of the previous 7 sessions and teaching the concept of psychological flexibility.
Category
Treatment - Other
2
Description
Control group: Asthma medical therapy will be medically treated based on the Global Initiative for Asthma protocolin which the patients will be treated in 4 categories..
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mahin Rabiei
Street address
Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
mahin.rabiei1987@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mortazavi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahin Rabiei
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8196736589
Phone
+98 31 3444 7707
Fax
Email
mahin.rabiei1987@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahin Rabiei
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8196736589
Phone
+98 31 3444 7707
Fax
Email
mahin.rabiei1987@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahin Rabiei
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8196736589
Phone
+98 31 3444 7707
Fax
Email
mahin.rabiei1987@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All of the data are accessible if the Professor permits
When the data will become available and for how long
Following the publication of the article
To whom data/document is available
The university students who have proposals related to the published article
Under which criteria data/document could be used
Only for the publication of an article and by the permission of the professor
From where data/document is obtainable
It should be taken through an email from the Professor
What processes are involved for a request to access data/document
It should be taken through an email from the Professor