The Comparison of the Effectiveness of Pharmacotherapy and online Compassion-Based Therapy in Reducing the Severity of Post Traumatic Symptoms, Increasing Post-Traumatic Growth, Improving Quality of life, and Studying Changes in Hippocampal and Amygdala Volume in Improved Patients with Coronavirus
Comparing the effectiveness of medical treatment and online compassion-focused treatment in reducing the severity of post-traumatic stress symptoms, increasing post-traumatic growth, improving quality of life, and studying the volume of the hippocampus and amygdala in recovered patients with coronavirus
Design
Clinical trial with intervention, control and follow-up group, phase 2 on 60 patients. The research design was semi-experimental with pre-test-post-test and follow-up with one control group and two experimental groups
Settings and conduct
The location of the experiment was in Shiraz city and the field of experimental research and how to conduct psychotherapy intervention online, drug therapy under the supervision of a psychiatrist and brain imaging were performed in person. Blinding was not used in this study
Participants/Inclusion and exclusion criteria
60 patients with delta variant of covid-19 diagnosed with symptoms of post-traumatic stress disorder in Shiraz city. Inclusion criteria: not having specific mental disorders, being literate in reading and writing, suffering from corona disease Exclusion criteria: not fully attending classes, having a mental disorder
Intervention groups
The first experimental group was subjected to compassion-focused therapy online (depending on the conditions and tools available to the patient) during eight sessions, and the second experimental group was under the supervision of a psychiatrist and treated with fluoxetine at a dose of 20 mg in a period of 6 It was used up to 8 weeks to treat post-traumatic stress disorder patients. The control group did not receive any treatment during this period.
Main outcome variables
Post-traumatic stress symptoms; growth after injury; The quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057849N1
Registration date:2023-05-04, 1402/02/14
Registration timing:retrospective
Last update:2023-05-04, 1402/02/14
Update count:0
Registration date
2023-05-04, 1402/02/14
Registrant information
Name
Fatemeh Modaresifard
Name of organization / entity
Islamic Azad Univercity of Marvdasht
Country
Iran (Islamic Republic of)
Phone
+98 71 3734 5881
Email address
fatemehmodaresifard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
2021-08-22, 1400/05/31
Actual recruitment end date
2021-09-06, 1400/06/15
Trial completion date
2022-09-15, 1401/06/24
Scientific title
The Comparison of the Effectiveness of Pharmacotherapy and online Compassion-Based Therapy in Reducing the Severity of Post Traumatic Symptoms, Increasing Post-Traumatic Growth, Improving Quality of life, and Studying Changes in Hippocampal and Amygdala Volume in Improved Patients with Coronavirus
Public title
Investigating the effect of fluoxetine and online compassion-focused therapy in the treatment of post-chronic patients with post-traumatic stress disorder
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1- Being a resident of Shiraz city 2- having a positive PCR in Delta variant Corona virus 3- having a history of hospitalization and discharge.
Exclusion criteria:
Older participant
Not living in Shiraz city
Not having a history of hospitalization in the corona ward
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
سامانه ملی اخلاق در پژوهش های زیست پزشکی
Street address
Floor.13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1467664962
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.IAU.M.REC.1401.015
Health conditions studied
1
Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
The percentage of people whose questionnaire score was reported to be low
Timepoint
Measuring the severity of post-traumatic stress symptoms, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention
Method of measurement
Post-traumatic growth and development questionnaire, post-traumatic stress disorder questionnaire (PCL-5), World Health Organization quality of life questionnaire - short form, brain imaging to measure the Hippocampus and Amygdala
2
Description
The percentage of people whose questionnaire scores are high
Timepoint
Measurement of growth and development after the accident, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention
Method of measurement
Post-traumatic growth and development questionnaire
3
Description
The percentage of people whose questionnaire scores are reported to be high
Timepoint
Measuring the quality of life, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention
Method of measurement
World Health Organization quality of life questionnaire - short form
4
Description
Changes in the size of the Hippocampus and Amygdala
Timepoint
At the beginning of the study (before the interventions) and one year after the interventions
Method of measurement
Brain imaging to measure the hippocampus and amygdala
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Pharmacotherapy: Prozac brand name، fluoxetine drug from the serotonin reuptake inhibitors (SSRIs) category at a dose of 20 mg, 2 times a day, morning and evening, in a period of 6 to 8 weeks, Exir pharmaceutical factory
Category
Treatment - Drugs
2
Description
The intervention group: Compassion-focused therapy, online, in eight ninety-minute sessions, once a week and in a group setting. description of meetings; The first session: getting to know the group members with each other, explaining the group rules, explaining the symptoms of post-traumatic stress, talking about their problems, explaining how the mind works and how and why it malfunctions. The second session: explanation and description of compassion: what compassion is and how to overcome problems through it. The third session: thinking about compassion towards others, paying attention and focusing on compassion, thinking about compassionate compassion, compassionate behavior, portraying compassion The fourth session: increasing warmth and energy, mindfulness, acceptance, wisdom and strength, warmth and non-judgment. Sixth session: practice the color of compassion, sound and image of compassion, and letter writing based on compassion .Seventh session: writing letters of compassion, practicing anger and compassion, practicing fear of compassion, preparing for the end of the group. Eighth session: reviewing, summarizing, ending the group's work, and doing the post-test
Category
Lifestyle
3
Description
Control group: They did not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zand Institute of Higher Education
Full name of responsible person
Ali Kamkar
Street address
inside Alley 12, South Iman (Hemet) Blvd., Shiraz.
City
Shiraz
Province
Fars
Postal code
7188773489
Phone
+98 71 3632 1041
Email
kamkarali@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Marvdasht
Full name of responsible person
Dr. Hasan Pour
Street address
Kilometer 3 of Takht Jamshid Blvd., Marvdasht, Fars
City
Marvdasht
Province
Fars
Postal code
13119-73711
Phone
+98 71 9130 0012
Email
admin@miau.ac.ir
Grant name
No specific grant was used to finance this study
Grant code / Reference number
درتامین مالی این مطالعه از گرنت مشخصی استفاده نشده است
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The financial sponsor of this thesis is the PhD student, Mrs. Fateme Modaresi Fard
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
American Psychological Association
Full name of responsible person
Fatemeh Modaresifard
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, Vafaie Blvd. 21Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7147885359
Phone
+98 71 3734 5881
Email
fatemehmodaresifard@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mohsen Zamir
Position
Professor & Psychiatric
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
North Nawab St., Shahid Salmani Alley. Qazvin University of Medical Sciences
City
Ghazvin
Province
Qazvin
Postal code
3419759811
Phone
009822833336001-5
Email
omidzamir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad Univercity of Marvdasht
Full name of responsible person
Fatemeh Modaresifard
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, 21 Ave., Vafaie Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7147885359
Phone
+98 71 3734 5881
Email
fatemehmodaresifard@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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of this study will be used in other similar researches for resources
From where data/document is obtainable
Future researchers should contact the responsible author via email to use the data of this study.
fatemehmodaresifard@gmail.com
What processes are involved for a request to access data/document
After sending the request email, the responsible author will send the data within a period of 7 days