The aim of this research was to study the effectiveness of partner assisted emotional disclosure therapy on alexithymia in patients with psychogenic non epileptic seizures(PNES).
Design
A randomized, single-blind, randomized controlled clinical trial study on 6 patients, randomization performed using lottery method.
Settings and conduct
After sampling, three patients underwent asynchronous emotional disclosure treatment with one-week intervals. Therapeutic sessions were held at the Behavioral Sciences Center of Shahid Chamran University of Ahvaz. In this study, the treatment of marital emotional disclosure was presented in eight sessions. The treatment protocol in this study was defined based on three baselines and the first patient entered the treatment stages after determining the third baseline. Then, after completing the baseline, each patient started the treatment process with an interval of one week. So the second patient entered the study in the second session of the treatment of the first patient, and the third patient entered in the third session of the treatment of the first patient, and the second session of the second patient. The treatment sessions were held for a month and a half, then follow-up sessions were held for two consecutive sessions with an interval of two weeks.
Participants/Inclusion and exclusion criteria
Informed consent for participating in the study, age 18 to 50 years, obtaining a standard deviation less than the average in the Alexithymia questionnaire
Intervention groups
The intervention group includes patients with psychogenic non epileptic seizures(PNES) who received 6 sessions of partner assisted emotional disclosure therapy, but the control group will not receive any intervention.
Main outcome variables
Alexithymia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100927004827N3
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Najmeh Hamid
Name of organization / entity
Shahid Chamran University
Country
Iran (Islamic Republic of)
Phone
+98 61 1445 1616
Email address
n.hamid@scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-27, 1400/07/05
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Partner Assisted Emotional Disclosure Therapy on Alexithymia in Patients with Psychogenic Non Epileptic Seizures(PNES)
Public title
The Effectiveness of Partner Assisted Emotional Disclosure on Alexithymia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Being married
Age 18 to 50 years
Having the ability to read and write
Acquiring one standard deviation below the mean in the Alexithymia questionnaire
Exclusion criteria:
Having a debilitating psychiatric illness
Acute physical illness
Having a known neurological condition like MS
History of a head injury or stroke
Drug abuse
Taking drugs related to the disease
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
First, by using the available sampling method, based on inclusion and exclusion criteria, the sample will be selected. After that, in order to randomly divide them into experimental and control groups, the lottery method will be used, i.e. the names of the individuals will be written one by one on a piece of paper and placed inside a box, then the papers will be randomly selected. Take it out of the box and assign it to each group in turn to complete the desired sample size and form two experimental and control groups.
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 Committee of Islamic Azad University - Ahvaz Branch
Street address
Kooye Golestan- College of Education and Psychology- Shahid Chamran University of Ahvaz- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
66287654532
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.IAU.AHVAZ.REC.1400.065
Health conditions studied
1
Description of health condition studied
Psychogenic Non Epileptic Seizures(PNES)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Alexithymia
Timepoint
three months
Method of measurement
Using a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, a single case experimental design with multiple asynchronous baseline will be used. The subjects of the intervention group enter the multi-baseline stage at the same time and randomly enter the treatment plan in the order of entering the baseline stage at the same time and randomly enter the baseline stage and treatment one by one at a distance of one session (one week). This treatment will include 8 to 12 sessions of 45 minutes over a six-week follow-up.
Category
Behavior
2
Description
The control group will not receive any intervention during this period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychology clinics and neurological treatment centers in Ahvaz
Full name of responsible person
Dr. Najmeh Hamid
Street address
Kooye Golestan, College of Education and psychology, Shahid Chamran University of Ahvaz, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
9876534634
Phone
+98 61 3445 1616
Email
n.hamid@scu.ac.ir
2
Recruitment center
Name of recruitment center
Neurosurgery Department of Ahvaz Golestan Hospital
Full name of responsible person
Dr. Najmeh Hamid
Street address
Golestan Alley - Golestan Hospital - Neurosurgery Department
City
Ahvaz
Province
Khouzestan
Postal code
4326572321
Phone
+98 61 3374 3521
Email
n.hamid@scu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr. Morteza Omidian
Street address
Golestan , Central Organization , Shahid Chamran University of Ahvaz, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
2345670984
Phone
+98 61 3333 0012
Email
morteza_omid@scu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
Proportion provided by this source
70
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
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr. Najmeh Hamid
Position
Associate Professor of Clinical Psychology of Shahid Chamran University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
College of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4536785431
Phone
+98 61 3445 1616
Email
n.hamid@scu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr. Najmeh Hamid
Position
Associate Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kooye Golestan, Shahid Chamran University of Ahvaz, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
9874563245
Phone
0098613330018
Email
n.hamid@scu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr. Najmeh Hamid
Position
Associate Professor of Clinical Psycholoy
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kooye Golestan, Shahid Chamran University of Ahvaz, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
8796542340
Phone
+98 61 3445 1616
Email
n.hamid@scu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome of the therapeutic intervention, is shared.
When the data will become available and for how long
The access period will start in 1399
To whom data/document is available
The data of this research will be available for researchers working in academic and scientific institutes or people who are also engaged in industry.
Under which criteria data/document could be used
Necessary conditions for sending a request for access to the data and the results and the research method of data analysis depend on the valid research centers
From where data/document is obtainable
Applicants should contact the principal of this research with the following email number to receive the required documents or results and information
What processes are involved for a request to access data/document
After 2 weeks, the information required by the applicants will be sent to them via email