View older revisions Content changed at 2024-07-31, 1403/05/10

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.
Main outcome variables
Resilience, recurring negative thoughts, anxiety, depression

General information

Reason for update
single blind
Acronym
IRCT registration information
IRCT registration number: IRCT20210728052006N1
Registration date: 2021-10-04, 1400/07/12
Registration timing: registered_while_recruiting

Last update: 2024-07-31, 1403/05/10
Update count: 1
Registration date
2021-10-04, 1400/07/12
Registrant information
Name
Parnaz Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 3862
Email address
baran.psychology2015@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2021-07-23, 1400/05/01
Ethics committee reference number
https://ethics.research.ac.ir/IR.QUMS.REC.1400.186

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified

Primary outcomes

1

Description
Resilience
Timepoint
10 sessions and 1 month
Method of measurement
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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...