1. Home
  2. Approved trials
  3. » فارسی

Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headache.

Protocol summary

Study aim
Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headach
Design
clinical trial with control group, with parallel group, One-way blind, Random, Phase one on 72 patients, Excel software rand function was used for randomization
Settings and conduct
This study will be conducted in a quasi-experimental and four groups. After purposeful selection and random assignment of participants in the three treatment groups and the control group, the experimental groups will be trained electronically before the pre-test training, after the post-test training and two months after the training. In this study, blinding will be done unilaterally in such a way that the statistical analyst will be unaware of the interventions provided to the experimental groups and the identification of the control group.
Participants/Inclusion and exclusion criteria
Diagnosis of migraine by a neurologist, Being in the age group of 18 to 55 Female gender, a minimum of secondary education,Not undergoing parallel psychological or psychiatric treatments, Having physical fitness (not having debilitating physical diseases such as MS, muscular and skeletal diseases) to participate in training courses,Determination and desire to participate in research and its continuation No migraine diagnosed by a neurologist,Being under the age of 18 and over 55
Intervention groups
Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training and control group
Main outcome variables
Pain Anxiety; Depression; Pain Self Efficacy; Resiliency; Affective Capital and Migraine Symptoms; Women; Migraine Headache

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200514047442N1
Registration date: 2021-12-06, 1400/09/15
Registration timing: prospective

Last update: 2021-12-06, 1400/09/15
Update count: 0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
afsaneh sartipzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 1191
Email address
afsane.sartipzade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-04-04, 1401/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headache.
Public title
Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of migraine by a neurologist, Being in the age group of 18 to 55 Female gender, a minimum of secondary education,Not undergoing parallel psychological or psychiatric treatments, Having physical fitness (not having debilitating physical diseases such as MS, muscular and skeletal diseases) to participate in training courses,Determination and desire to participate in research and its continuation.
Exclusion criteria:
No migraine diagnosed by a neurologist,Being under the age of 18 and over 55..
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study are divided into 4 groups of 18 people and randomly assigned to 3 intervention and control groups.Reminds about how to randomize afterInitial interview and initial screening, 72 women with the criteria to enter the study were selected, then by coding and using the lottery method, 18 people are divided into four groups by the lottery method into three experimental groups based on type The intervention and a control group are divided
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know the type of actions for the groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IRAN NATION COMMITEE FOR ETICS IN BIOMEDICAL RESEARCH
Street address
kerman
City
kerman
Province
Kerman
Postal code
8163867691
Approval date
2021-06-02, 1400/03/12
Ethics committee reference number
IR-IAU.KHUISF.REC.1400.057

Health conditions studied

1

Description of health condition studied
migrain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain Anxiety
Timepoint
pretest-posttest- two months follow up
Method of measurement
Pain Anxiety scale

2

Description
Pain Self Efficacy
Timepoint
pretest-posttest- two months follow up
Method of measurement
Pain Self Efficacy scale

3

Description
Depression
Timepoint
pretest-posttest- two months follow up
Method of measurement
Beck Depression scale

4

Description
resiliency
Timepoint
pretest-posttest- two months follow up
Method of measurement
Conner-Davidson resiliency scale

5

Description
Affective Capital
Timepoint
pretest-posttest- two months follow up
Method of measurement
Affective Capital scale

6

Description
Migraine Symptoms
Timepoint
pretest-posttest- two months follow up
Method of measurement
Migraine Symptoms scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive Behavioral therapy Focused on Isomnia
Category
Treatment - Other

2

Description
Intervention group: Mindfulness Based Cognitive therapy
Category
Treatment - Other

3

Description
Intervention group: Fordyce Happiness training
Category
Treatment - Other

4

Description
Control group: not intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک های روانپزشکی
Full name of responsible person
مدیر کلینیک های روانپزشکی
Street address
خیابان طهماسب آباد
City
kerman
Province
Kerman
Postal code
8163867691
Phone
+98 34 3245 8975
Email
myazdani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
dr golparvar
Street address
خیابان ارغوانیه
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Web page address
http://new.khuisf.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Aida Elham
Position
TEACHER
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
SHAHID BEHESHTI STREET
City
kerman
Province
Kerman
Postal code
8163867691
Phone
+98 34 3211 3883
Email
afsane.sartipzade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Golparvar
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arghavanieh Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
0319-35354001
Email
drmgolparvar@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
afsaneh sartipzadeh
Position
Mental health expert
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
ebne sina street
City
ISFAHAN
Province
Isfehan
Postal code
8148653374
Phone
+98 31 3448 8865
Email
afsane.sartipzade@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
The results of the analysis of participants' individual data are shared
When the data will become available and for how long
20.4.2022-208.2022
To whom data/document is available
All researchers
Under which criteria data/document could be used
In order to use the results of the analysis in future research
From where data/document is obtainable
From the site of the journals in which the extracted article is published
What processes are involved for a request to access data/document
If the article is published in scientific research journals, the author's email address will be posted on the site and researchers can request the necessary information by sending a request to the author's email address. After reviewing the requests by the author, if approved, the authorized information will be sent to researchers
Comments
Loading...