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Comparison of the effectiveness of acceptance and commitment therapy (ACT) with compassion-focused therapy on emotion regulation, anxiety tolerance and flexibility in women with migraine

Protocol summary

Study aim
Comparing the effectiveness of acceptance and commitment therapy with compassion-focused therapy on Emotion Regulation, Distress Tolerance, and Resilience in Women with Migraine
Design
A randomized clinical trial with the control group, parallel groups, without blinding. The number of 108 qualified samples will be included in the study using the convenience sampling method and will be randomly assigned to the study groups using cards/envelope shuffling method.
Settings and conduct
Group therapy is held for 8 sessions of one and a half hours for each approach, once a week in a selected counseling center in Ahvaz city. After the end of the research, 4 treatment sessions will be performed for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Migraine disease with the diagnosis of a specialist doctor, having a minimum education of a diploma to do homework, and age range of 20-50 years. Exclusion criteria: Having a head injury or injury, participating in educational workshops related to acceptance and commitment therapy and compassion-based therapy outside of therapy sessions, not cooperating with the therapist, suffering from severe medical mental disorders as diagnosed by a psychological specialist through a diagnostic interview, having dependence or substance abuse, the absence of evidence based on the existence of a serious and chronic physical illness that requires treatment.
Intervention groups
In the acceptance and commitment therapy group, the concepts of therapy based on acceptance and commitment will be taught in group sessions (8 sessions of one and a half hours). In the compassion-focused therapy group, the concepts of compassion-based therapy will be taught in group sessions (8 one-and-a-half-hour sessions). No intervention will be done in the control group.
Main outcome variables
Emotion regulation, anxiety tolerance, and flexibility in women

General information

Reason for update
Acronym
(ACT) (CFT)
IRCT registration information
IRCT registration number: IRCT20220517054892N1
Registration date: 2023-06-08, 1402/03/18
Registration timing: retrospective

Last update: 2023-06-08, 1402/03/18
Update count: 0
Registration date
2023-06-08, 1402/03/18
Registrant information
Name
Farima Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 7064
Email address
fv.foroughi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-25, 1402/01/05
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acceptance and commitment therapy (ACT) with compassion-focused therapy on emotion regulation, anxiety tolerance and flexibility in women with migraine
Public title
Comparision ( ACT) & (CFT) on psychological values in migraine
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine disease with the diagnosis of a specialist doctor. Having a minimum education of a diploma to do homework, and age range of 20-50 years.
Exclusion criteria:
The main conditions of not entering the study before randomization:Having a head injury or injury, participating in educational workshops related to acceptance and commitment therapy and compassion-based therapy outside of therapy sessions, not cooperating with the therapist, suffering from severe medical mental disorders as diagnosed by a psychological specialist through a diagnostic interview, Having dependence or substance abuse, and the absence of evidence based on the existence of a serious and chronic physical illness that requires treatment
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be such that 108 cards are prepared and in 36 of the cards the letter A (for the treatment group focused on acceptance and commitment), in 36 cases the letter B (for the treatment group focused on compassion) and in 36 cases the letter C (for the control group) will be recorded. Subjects will appear at a certain time in a place prepared for this purpose in advance, and each person will be randomly assigned to the group registered inside the card by picking a card that will be placed inside a sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz branch
Street address
Azad University, Farhangshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155954394
Approval date
2022-12-08, 1401/09/17
Ethics committee reference number
IR.IAU.AHVAZ.REC.1401.185

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.909
ICD-10 code description
Migraine, unspecified, not intractable, without status migrainosus

Primary outcomes

1

Description
Psychological flexibility: The score obtained from the 20-question questionnaire of Dennis and Vanderwaal (2011).
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention
Method of measurement
Dennis and Vanderwal psychological flexibility questionnaire

2

Description
Distress tolerance: The score obtained from the 15-question questionnaire of Simon and Gaher's Distress Tolerance Questionnaire.
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention
Method of measurement
Simon and Gaher Distress Tolerance Scale

3

Description
Emotional regulation: The score obtained from the 36-question emotional regulation questionnaire of Garnevsky et al. (2002).
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention
Method of measurement
Garnevsky cognitive emotion regulation questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: does not receive any training or intervention.
Category
N/A

2

Description
Compassion-focused therapy: In group sessions (8 sessions, each session for an hour and a half) will teach about the concepts of compassion-focused therapy. These concepts will be taught and discussed in the context of structured group therapy sessions.
Category
Rehabilitation

3

Description
Acceptance and Commitment Therapy: In group sessions (8 sessions, each session for one and a half hours), the concepts of therapy based on acceptance and commitment will be taught. These concepts will be taught and discussed in the context of structured group therapy sessions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of Dr Hossein Safari
Full name of responsible person
Dr Hossein Safari
Street address
Medical complex of East of kianpars, East 14 Street, Kianpars Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۵۵۸۶۴۸۹۵
Phone
+98 61 3337 6416
Email
Hoseinsafari1382@gmail.com

2

Recruitment center
Name of recruitment center
Mehrawaran counselling center
Full name of responsible person
Mohamadreza Kefayat
Street address
No. 398, between Kafi & Jahanian Street, Hafez Ave, Naderi Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6195665917
Phone
+98 61 3223 7722
Email
Mehrawaran32221313@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam gholamzade jefre
Street address
Azad University, Farhanshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Email
Gholamzadeh.m723@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam gholamzade jefre
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azad University, Farhangshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
۰۰۹۸ ۳۳ ۳۴۸۴۲۰
Email
Gholamzadeh.m723@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farima Foroughi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 19, East 9 Street, Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۵۵۹۵۴۳۹۴
Phone
+98 61 3338 7064
Email
fv.foroughi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farima Foroughi
Position
Student of consultant, phd
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.19, 9 East Street, Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155954394
Phone
+98 61 3338 7064
Fax
Email
Fv.foroughi@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information about the pre-test and post-test of the participants will be published after the end of the study.
When the data will become available and for how long
The data access period will start six months after the end of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers who need data to conduct research under common scientific and humanitarian ethical standards can submit their request by email.
From where data/document is obtainable
You should send your request to these two emails. fv.foroughi@gmail.com and Gholamzadeh.m723@gmail.com
What processes are involved for a request to access data/document
The researcher sends her request in writing to the mentioned two emails and within ten days, her request will be reviewed and if approved, the data will be sent to her.(feminine)
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