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Comparison of the effect of mindfulness-based cognitive therapy(MBCT) and acceptance and commitment therapy(ACT) on improving self-efficacy, self-esteem and quality of life in patients with focal epilepsy

Protocol summary

Study aim
Determining the effect of MBCT and acceptance and commitment therapy (ACT) on increasing self-efficacy, self esteem, improving the quality of life of patients with focal epilepsy and comparing the effect of the two above-mentioned treatments
Design
Sample available for 36 people
Settings and conduct
Coordination with predicted centers, satisfaction, inclusion of patients randomly in two groups of experimental and control groups of Achievements in three levels of self-efficacy of patients with epilepsy (ESE), Cooper Smith's self-esteem and Ware and Sherborne's quality of life - 31 questions Specified for patients with epilepsy (QOLIE-31) as a pretest, then intervention and cognitive-mindedness-based cognitive therapy (MBCT) in a test group for 8 sessions of 2 hours, intervention and acceptance and commitment therapy (ACT) in the other group Experiments for 6 to 8 sessions, then again, all three groups will be tested and evaluated with three scales, to ensure the effectiveness of the intervention methods
Participants/Inclusion and exclusion criteria
All patients with focal epilepsy living in East Azarbaijan who referred to medical centers from the beginning of 1397 to the end of September 1398 Entry criteria: Diagnosis of focal epilepsy by a specialist physician, aged 18 to 30 years, written consent of the patient or his or her family. Exit criteria: Patient or family request, trauma and brain lesions, other severe physical illnesses, other severe psychiatric disorders, absences in more than two sessions of treatment
Intervention groups
The experimental group 1 (ACT intervention), the experimental group 2 (MBCT intervention) and group 3 (control)
Main outcome variables
Improve self-esteem, self-efficacy, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190205042634N1
Registration date: 2019-02-24, 1397/12/05
Registration timing: prospective

Last update: 2019-02-24, 1397/12/05
Update count: 0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
mohammad mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 4279
Email address
mmpour2009@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of mindfulness-based cognitive therapy(MBCT) and acceptance and commitment therapy(ACT) on improving self-efficacy, self-esteem and quality of life in patients with focal epilepsy
Public title
Comparison of the effect of mindfulness-based cognitive therapy(MBCT) and acceptance and commitment therapy(ACT) on epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of focal epilepsy by specialist physician age 18 to 30 years of patients written consent of the patient or his or her family
Exclusion criteria:
Lack of readiness of the patient or his or her family Trauma and brain lesions Other severe physical illnesses Excessive psychiatric disorders Failure to continue the treatment session
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly and simply assigned to each individual and using the lottery containing the titles of the three groups (1,2 and 3) in both the experimental and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to ensure the effectiveness of interventions and improve the quality of life and control the relative symptoms of the disease, the test group will be re-evaluated at a follow-up period of about three months.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Central Headquarter of University, Bassij Blvd
City
semnan
Province
Semnan
Postal code
3514799422
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SEMUMS.REC.1397.237

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures

Primary outcomes

1

Description
The quality of life scores obtained by the subjects in the Ver-Sherborne Quality of Life Questionnaire (SF-36), the self-efficacy scores obtained by the subjects on the self-efficacy scale of patients with epilepsy (ESE), and the self-esteem score that subjects were given in the Dignity Inventory Breathe coprasmith
Timepoint
Before the intervention, after the intervention and three months after the intervention in the follow up period
Method of measurement
ware and Sherbourne Quality of Life Questionnaire (SF-36) for Quality of Life, Self-Efficacy Scale for Epilepsy Patients (ESE), to assess self-efficacy and Cooper smith's self-esteem questionnaire for assessing self-esteem

Secondary outcomes

1

Description
Reduce the frequency of seizure attacks
Timepoint
Three months after the intervention
Method of measurement
Redefining Epilepsy Symptoms Scale (ESS)

Intervention groups

1

Description
Acceptance and Commitment therapy(ACT) and meetings that will be conducted in 8 consecutive weeks in accordance to protocol for 8 consecutive 90-minute sessions.
Category
Treatment - Other

2

Description
Mindfulness-based cognitive therapy and the use of techniques that the experimental group No 2, the eighth consecutive session and in accordance with the protocol in question will receive 8 weeks.
Category
Treatment - Other

3

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
ِِّّRazi Hospital in Tabriz
Full name of responsible person
ِDr. <Ghasem khazan
Street address
Shahid Bakeri Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Fax
+98 41 3380 3351
Email
info@prazi.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Seyf A ... Saadoddin
Street address
Opposite Sokan Park - Campus No. 1
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3153 5859
Email
p_relations@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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

2

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
دکتر سیف ا... سعدالدین
Street address
Opposite Sokan Park - Campus No. 1
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3153 5859
Email
p_relations@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
The University of Semnan
Full name of responsible person
Mohammad Mohammadpour
Position
مشاور
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vali a Asr Alley
City
Tabriz
Province
East Azarbaijan
Postal code
5158951943
Phone
+98 41 3669 4279
Email
mmpour2009@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Mohammadpour
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Valley-e- Asr. 2 - Jamaran Complex - Block 23 - Stairs 4 - Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5158951943
Phone
+98 41 3669 4279
Fax
+98 41 3336 2354
Email
mmpour2009@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Mohammadpour
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Valley-e- Asr. 2 - Jamaran Complex - Block 23 - Stairs 4 - Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5158951943
Phone
+98 41 3669 4279
Fax
+98 41 3336 2354
Email
mmpour2009@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The original outcome data can be shared
When the data will become available and for how long
The start of the access period will be from the beginning of 2020
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
For statistical purposes, statistical analysis is available to researchers
From where data/document is obtainable
Refer to Tabriz Central Library Department to receive data
What processes are involved for a request to access data/document
The use of data is available In person and on-line
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