Comparison of effect of Stress Management, Emotion Regulation, Eye Movement Desensitization and Reprocessing Therapy in Improving Resilience, Repetitive Negative Thoughts, Anxiety and Depression in Patients with Covid 19
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General information
Not blinded
Single blinded
notblsingl
1
1
empty
single blind
single blind
empty
یک سوکور
یک سوکور
The evaluator was not aware of the allocation of any of the groups.
The evaluator was not aware of the allocation of any of the groups.
ارزیاب گر از تخصیص هیچ کدام از گروه ها مطلع نبوده است.
ارزیاب گر از تخصیص هیچ کدام از گروه ها مطلع نبوده است.
Recruitment centers
#1
Name of recruitment center - English: Velayat Educational and medical center
Name of recruitment center - Persian: مرکز آموزشي درماني ولايت
Full name of responsible person - English: Parnaz Mardani
Full name of responsible person - Persian: پرناز مرداني
Street address - English: Qazvin, Minoodar, Elahieh Alley, 22 Bahman Blvd., Cooperative Square, Velayat Educational and Medical Center
Street address - Persian: قزوین ،مینودر، کوی الهیه ، بلوار 22 بهمن ، میدان تعاون، مرکز آموزشی و درمانی ولایت
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34719-76161
Phone: +98 28 3379 0620
Fax:
Email: parnazmardaniii@gmail.com
Web page address:
Name of recruitment center - English: Velayat Educational and medical center
Name of recruitment center - Persian: مرکز آموزشي درماني ولايت
Full name of responsible person - English: Parnaz Mardani
Full name of responsible person - Persian: پرناز مرداني
Street address - English: Elahieh Alley, 22 Bahman Blvd, Cooperative Square, Qazvin Town
Street address - Persian: قزوین ،مینودر، کوی الهیه ، بلوار 22 بهمن ، میدان تعاون، مرکز آموزشی و درمانی ولایت
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34719-76161
Phone: +98 28 3379 0620
Fax:
Email: parnazmardaniii@gmail.com
Web page address:
Name of recruitment center - English: Velayat Educational and medical center Name of recruitment center - Persian: مرکز آموزشي درماني ولايت Full name of responsible person - English: Parnaz Mardani Full name of responsible person - Persian: پرناز مرداني Street address - English: Qazvin, Minoodar, Elahieh Alley, 22 Bahman Blvd., Cooperative Square, Velayat Educational and Medical CenterQazvin Town Street address - Persian: قزوین ،مینودر، کوی الهیه ، بلوار 22 بهمن ، میدان تعاون، مرکز آموزشی و درمانی ولایت City - English: Qazvin City - Persian: قزوين Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 34719-76161 Phone: +98 28 3379 0620 Fax: Email: parnazmardaniii@gmail.com Web page address:
#2
Name of recruitment center - English: Booali Sina Medical Center
Name of recruitment center - Persian: خیابان بوعلی مرکز آموزشی درمانی بوعلی سینا
Full name of responsible person - English: Parnaz Mardani
Full name of responsible person - Persian: پرناز مرداني
Street address - English: Booali Sina St. Booali Sina Medical Center
Street address - Persian: خیابان بوعلی مرکز آموزشی درمانی بوعلی سینا
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34156-13911
Phone: +98 28 3333 2930
Fax:
Email: parnazmardaniii@gmail.com
Web page address:
Name of recruitment center - English: Booali Sina Medical Center
Name of recruitment center - Persian: خیابان بوعلی مرکز آموزشی درمانی بوعلی سینا
Full name of responsible person - English: Parnaz Mardani
Full name of responsible person - Persian: پرناز مرداني
Street address - English: Booali St.
Street address - Persian: خیابان بوعلی
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34156-13911
Phone: +98 28 3333 2930
Fax:
Email: parnazmardaniii@gmail.com
Web page address:
Name of recruitment center - English: Booali Sina Medical Center Name of recruitment center - Persian: خیابان بوعلی مرکز آموزشی درمانی بوعلی سینا Full name of responsible person - English: Parnaz Mardani Full name of responsible person - Persian: پرناز مرداني Street address - English: Booali Sina St. Booali Sina Medical Center Street address - Persian: خیابان بوعلی مرکز آموزشی درمانی بوعلی سینا City - English: Qazvin City - Persian: قزوين Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 34156-13911 Phone: +98 28 3333 2930 Fax: Email: parnazmardaniii@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hosein Javdani
Full name of responsible person - Persian: حسين جاوداني
Street address - English: Qazvin, Shahid Bahonar Blvd., Qazvin University of Medical Sciences, Vice Chancellor for Research
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین، معاونت پژوهشی
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +98 28 3333 6001
Fax:
Email: javdani_md@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hosein Javdani
Full name of responsible person - Persian: حسين جاوداني
Street address - English: University of Medical Sciences, Qazvin.
Street address - Persian: قزوین. دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوين
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +98 28 3333 6001
Fax:
Email: javdani_md@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hosein Javdani Full name of responsible person - Persian: حسين جاوداني Street address - English: Qazvin, Shahid Bahonar Blvd., Qazvin University of Medical Sciences, Vice Chancellor for ResearchQazvin. Street address - Persian: قزوین، بلوار شهید باهنر،. دانشگاه علوم پزشکی قزوین، معاونت پژوهشی City - English: Qazvin City - Persian: قزوين Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 3419759811 Phone: +98 28 3333 6001 Fax: Email: javdani_md@yahoo.com Web page address:
Protocol summary
Study aim
Comparison of effect of Stress Management, Emotion Regulation, Eye Movement Desensitization and Reprocessing Therapy in Improving Resilience, Repetitive Negative Thoughts, Anxiety and Depression in Patients with Covid 19
Design
Clinical trial with parallel groups, not blinded, a sample of 80 patients with Covid_19 disorder will be selected by available sampling and will be randomly assigned to 4 groups. 3 groups will receive treatment and one group will be evaluated as a control group. Generator number random v1.3 software was used for randomization.
Settings and conduct
Samples will be referred by a psychiatrist colleague according to the entry criteria and will be included in the test groups if they are not subject to the exit criteria. Then, after obtaining informed consent to participate in the study, the Conner and Davidson Scale Resilience Questionnaire, the Negative Repetitive Thought Questionnaire, and the DASS Depression, Anxiety, and Stress Questionnaire are presented, and we compare the scores obtained from the questionnaire. . Then the stress management treatment program and the treatment of emotion regulation and desensitization with eye movement and reprocessing will be implemented. After performing the interventions of the questionnaires, the score obtained from the questionnaires will be compared again and the mentioned test will be performed again and also 1 month after the end of the intervention in order to follow up the results.
Participants/Inclusion and exclusion criteria
Depression and anxiety diagnosed by a psychiatrist and hospitalized in Corona Hospital
Intervention groups
3 groups receive intervention, stress management treatment, emotion regulation, eye desensitization and reprocessing, and a control group will receive no treatment.
Comparison of effect of Stress Management, Emotion Regulation, Eye Movement Desensitization and Reprocessing Therapy in Improving Resilience, Repetitive Negative Thoughts, Anxiety and Depression in Patients with Covid 19
Public title
The effectiveness of stress management, emotion regulation and desensitization treatments with eye movement and reprocessing on depression and anxiety in patients with Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients referred to the clinics and hospitals accepting Corona. suffering from depression and anxiety at the diagnosis of a psychiatrist. aged 18 and up to 60 years.
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Generator v1.3 program will be used to assign sample members to four experimental groups. In this way, the number of sample people is given to this software and this program randomly places each number in a group according to its function.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator was not aware of the allocation of any of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Connor and Davidson scale resilience questionnaire
2
Description
Repeated negative thoughts
Timepoint
10 sessions and 1 month
Method of measurement
Negative Repetitive Thoughts Questionnaire
3
Description
Depression
Timepoint
10 sessions and 1 month
Method of measurement
DASS Depression Inventory
4
Description
anxiety
Timepoint
10 sessions and 1 month
Method of measurement
DASS Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive-behavioral stress management group intervention sessions, 10 sessions for 1.5 hours and one session per week.
Category
Behavior
2
Description
Intervention group 2: Emotion regulation group intervention sessions based on Gross regulatory strategies, 10 sessions for 1.5 hours and one session per week.
Category
Behavior
3
Description
Intervention group 3: Group intervention sessions of desensitization with eye movement and reprocessing, 8 sessions for 1.5 hours and one session per week will be held.
Category
Behavior
4
Description
Control group: They will not receive any treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Educational and medical center
Full name of responsible person
Parnaz Mardani
Street address
Elahieh Alley, 22 Bahman Blvd, Cooperative Square, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34719-76161
Phone
+98 28 3379 0620
Email
parnazmardaniii@gmail.com
2
Recruitment center
Name of recruitment center
Booali Sina Medical Center
Full name of responsible person
Parnaz Mardani
Street address
Booali St.
City
Qazvin
Province
Qazvin
Postal code
34156-13911
Phone
+98 28 3333 2930
Email
parnazmardaniii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hosein Javdani
Street address
University of Medical Sciences, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
javdani_md@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Zanjan University of Medical Sciences
Full name of responsible person
Parnaz Mardani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farakhodro Store, Janbazan st, Hakim Blvd
City
Qazvin
Province
Qazvin
Postal code
3414757525
Phone
+98 28 3369 5267
Email
parnazmardaniii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parnaz Mardani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farakhodro Store, Janbazan st, Hakim Blvd
City
Qazvin
Province
Qazvin
Postal code
3414757525
Phone
+98 28 3369 5267
Email
parnazmardaniii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parnaz Mardani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farakhodro Store, Janbazan st, Hakim Blvd
City
Qazvin
Province
Qazvin
Postal code
3414757525
Phone
+98 28 3369 5267
Email
parnazmardaniii@gmail.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