Comparing the effectiveness of Emotion-focused therapy and cognitive rehabilitation based on Rehacom software on Emotional and cognitive components in female patients with migraine
Determine and Comparing the effectiveness of emotion focused therapy and cognitive rehabilitation based on Rehakam software on emotional and cognitive components in patients with migraine
Design
The research method is a clinical randomi focused therapy and the intervention group of cognitive rehabilitation based on Rehakam software and the control group and stage; There will be a pre-test and a post-test.
Settings and conduct
In this research, 45 female patients with migraine will be selected in a targeted way by a neurologist at the Imam Ali Clinic in Yazd and will be randomly assigned to experimental and control groups (15 people in each group) and the intervention will last for a period of It will last 2 months and the variables of empathy, emotional beliefs, attention and depression, anxiety and stress will be investigated
Participants/Inclusion and exclusion criteria
Getting a medium to high score on the pain measurement scale
Female gender
Age range from 18 to 45 years
Consent and willingness to participate in educational and research meetings
Definitive diagnosis of migraine by a neurologist
Minimum reading and writing literacy to respond to study tools
Willingness to continue participating in the research process
No other chronic disease
Not receiving simultaneous psychological intervention
No drug use
Absence of more than two sessions during the training period
Intervention groups
There are two groups, emotion focused therapy and cognitive rehabilitation interventions based on Rehakam software will be applied separately on each of the groups, While the third group: the control group will not receive these interventions and will only receive psychological training.
Main outcome variables
Variables of emotional beliefs; empathy; Attention; executive performance; depression; Anxiety and stress are evaluated and compared with the questionnaire before and after
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240722062505N1
Registration date:2024-08-15, 1403/05/25
Registration timing:registered_while_recruiting
Last update:2024-08-15, 1403/05/25
Update count:0
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Mojgan Bakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 3501
Email address
mojganbakhshi89@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Emotion-focused therapy and cognitive rehabilitation based on Rehacom software on Emotional and cognitive components in female patients with migraine
Public title
Investigating the effect of emotion-focused therapy and cognitive rehabilitation based on Rehakam software on migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining a medium to high score on the pain measurement scale (VAS)
Female gender - age range 18 to 45 years
Consent and willingness to participate in educational and research meetings
A definitive diagnosis of migraine by a neurologist based on the criteria of the International Headache Society scale (2003) (headache experience in the last one month and 5 times in the last 6 months)
Minimum reading and writing literacy to respond to study tools
Willingness to continue participating in the research process
Cooperation and doing defined tasks
Exclusion criteria:
No other self-reported chronic diseases ( like multiple sclerosis and lupus)
Not Receiving concurrent psychological intervention
No Drug use that interferes with the implementation of cognitive rehabilitation software
Absence of more than two sessions during the training period
Age
From 18 years old to 45 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
45 women with migraine headaches will be selected and randomly assigned to three experimental and control groups. (15 women with migraines in the emotional focused therapy intervention group, 15 women with migraines in the cognitive rehabilitation group based on Rehakam software, 15 women with migraines without intervention).
Women with migraine in experimental groups of therapeutic interventions related to the emotional focused therapy They will receive circuit (8 sessions of 90 minutes) once a week and Rehakam software (8 sessions in 3 weeks and each session is 20 minutes).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Islamic Azad University -Shiraz branch
Street address
Alley No. 7, No. 41,East Tubi St.,Safaiye University Town
City
yazd
Province
Yazd
Postal code
8916115533
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1403.130
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Depression score in DASS-21 questionnaire
Timepoint
Measurement of depression before the intervention and after the intervention
Method of measurement
Questionnaire DASS-21
2
Description
Anxiety score in DASS-21 questionnaire
Timepoint
Measuring anxiety before the intervention and after the intervention
Method of measurement
Questionnaire DASS-21
3
Description
Stress score in DASS-21 questionnaire
Timepoint
Measuring stress before the intervention and after the intervention
Method of measurement
Questionnaire DASS-21
4
Description
Perth Empathy Questionnaire
Timepoint
Measuring empathy before the intervention and after the intervention
Method of measurement
Perth Empathy Scale
5
Description
emotional beliefs score in emotional beliefs questionnaire
Timepoint
Measuring emotional beliefs before the intervention and after the intervention
Method of measurement
Emotion Beliefs Questionnaire
6
Description
Attention score from Rehakam cognitive rehabilitation software
Timepoint
Measurement of attention before the intervention and after the intervention
Method of measurement
Rehacom cognitive rehabilitation software
7
Description
Executive function score from Rehakam cognitive rehabilitation software
Timepoint
Measuring executive function before the intervention and after the intervention
Method of measurement
Rehacom cognitive rehabilitation software
8
Description
Migraine score from visual analog scale (VAS)
Timepoint
Migraine measurement before sampling
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Iemotion focused therapy. In this study, Suzan Johnson's (2010) emotion focused therapy protocol, which was used in the research of Khairi (2019), Kavianpour (2015), Balai et al. (1400),was used. This protocol will be implemented during eight sessions of one and a half hours.
Category
Treatment - Other
2
Description
In this research, Rehacam cognitive rehabilitation software (HASOMED) GmbH, Magdeburg, Germany, 1997) was used in the research of Saeb et al. (1401) and Amiri et al. (2017). will be used. In this research, the version (Rehacam.6.8.0.0-DE-Hasomed Archive-1) and the treatment window for attention and executive function will be used. The duration of the intervention period is 8 sessions during 3 weeks and each session will be carried out individually for 20 minutes. This software will be implemented in 5 stages. The first stage, patient screening; The second step is choosing the appropriate treatment modules; The third stage, compliance; The fourth stage was the beginning of the treatment and the fifth stage was the analysis of the treatment results.
Category
Rehabilitation
3
Description
Control group: will not receive any intervention. They will only receive psychological training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Specialized Clinic
Full name of responsible person
Reza Bidaki
Street address
Nawab Safavi Blvd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3630 1703
Email
reza_bidaki@yahoo.com
Web page address
http://emamali.ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Davoodi
Street address
Fars, Shiraz, kilometer five of Sadra road, Islamic Azad University, Shiraz branch, Shahid Soleimani building
City
Fars
Province
Fars
Postal code
1-71993
Phone
+98 71 3619 1536
Email
Azam.Davoodi@iau.ac.ir
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
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
Mojgan Bakhshi
Position
Imployee and phd candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Clean 41 No. 41, No. 7, Alley No. 7, East Tubi Street, University Town
City
Yazd
Province
Yazd
Postal code
8916115533
Phone
+98 35 3821 3501
Fax
Email
mojganbakhshi89@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojgan Bakhshi
Position
Imployee and phd candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alley No. 7, No. 41,East Tubi St.,Safaiye University Town
City
yazd
Province
Yazd
Postal code
8916115533
Phone
+98 35 3821 3501
Email
Mojganbakhshi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojgan Bakhshi
Position
Imployee and phd candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alley No. 7, No. 41,East Tubi St.,Safaiye University Town
City
yazd
Province
Yazd
Postal code
8916115533
Phone
+98 35 3821 3501
Email
Mojganbakhshi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD