Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV
Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV
Design
90 people with HIV will be selected as a research sample. Then the statistical sample was randomly divided into 3 different groups; Group 1: Cognitive therapy based on mindfulness (30 people), Group 2: Silva method relaxation (30 people), and Group 3: Control (30 people) will be replaced.
Settings and conduct
This study is in the field of psychology education and will be conducted at the Behavioral Diseases Counseling Center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Infected with HIV، Having full satisfaction for cooperation، Absence of acute disorders in the field of psychology and psychiatry، Not using drugs; Psychiatric drugs، Being literate in reading and writing
Exclusion criteria:
Refusal to cooperate with the researcher، Absence of more than two sessions in therapy training
Intervention groups
90 people will be randomly divided into 3 different groups: cognitive therapy based on mindfulness (30 people), Silva method relaxation (30 people) and control (30 people). In this research, cognitive therapy training based on mindfulness and relaxation will be conducted in the Silva way. Before implementing the aforementioned treatments, a pre-test will be performed for all three groups (completion of Lutans psychological capital and Lajarka social anxiety questionnaires, as well as 2 ml blood sampling (CD4)). Then, after two weeks of completing the training, the post-test will be conducted for all 3 groups, similar to the pre-test.
Main outcome variables
Evaluation of effective and applicable community-based interventions to promote mental health literacy in HIV-positive groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050373N5
Registration date:2023-03-11, 1401/12/20
Registration timing:prospective
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Seyed ahmad Seyed alinaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1583
Email address
s_a_alinaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV
Public title
Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
HIV infection
Having full consent to cooperate
Absence of acute disorders in the field of psychology and psychiatry
Not using drugs; Psychiatric drugs
Being literate in reading and writing
Exclusion criteria:
Refusing to cooperate with the researcher
Absence of more than two sessions in therapy training
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
90 people with HIV will be selected as a research sample. Then the statistical sample was randomly divided into 3 different groups including Group 1: Mindfulness-based cognitive therapy (30 people), Group 2: Silva-based relaxation therapy (30 people) and Group 3: Control (30 people) will be replaced.
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used for randomization. According to the three study groups, blocks of fixed size will be used in this research, with six patients in each block.
After generating the randomization sequence using the software (Random allocation software), the central randomization method will be used for allocation concealment.
To implement allocation concealment using the central randomization method, the generated randomization sequence is provided to the research department of the Iranian Research Center for HIV/AIDS (IRCHA).
After the patients' eligibility to enter the study and obtaining written informed consent from the patients, the researchers will call (phone) the relevant center (IRCHA) and ask about the allocation of the participants to the study groups.
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
Ethics committee of Imam khomeini Hospital Complex- Tehran University of Medical Sciences
Conscious attention in the present with acceptance and non-judgment
Timepoint
1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention
Method of measurement
Questionnaire
2
Description
Awareness and alertness based on care and attention
Timepoint
1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention
Method of measurement
Questionnaire
3
Description
Increase mental strength and concentration
Timepoint
1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention
Method of measurement
Questionnaire
4
Description
CD4 count
Timepoint
1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Mindfulness-based cognitive therapy group training: Before the training, a pre-test will be conducted. In this way, the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, cognitive therapy sessions based on mindfulness will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test.
Category
Lifestyle
2
Description
Intervention group 2: Silva-based relaxation therapy: Group relaxation training in the Silva method: Before the implementation of the training, a pre-test will be performed. In this way, the research questionnaires (Lutans psychological capital and Lajerka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, the Silva relaxation sessions will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test.
Category
Lifestyle
3
Description
Control group: they don't see any training. The pre-test will be conducted in such a way that the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml of blood sampling will be done for the CD4 count. After the pre-test and after cognitive therapy training sessions based on mindfulness and Silva-based relaxation therapy were implemented for the intervention groups, after two weeks From the implementation of the trainings, the "post-test" will be implemented like the pre-test for the control group.
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
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
Title and more details about the data/document
The research results will be presented and published only in the form of reports and articles.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers for use in articles and reports, especially systematic review articles.
From where data/document is obtainable
To receive the required documents or data, refer to the project manager, Dr. Seyed Ahmad Seyed Alinghi, at the Iranian Research Center for HIV/AIDS. Phone number: 00982166581583 Email: s.a.alinaghi@gmail.com Address: Iranian Research Center for HIV/AIDS, behind the Infectious Diseases Building, Imam Khomeini Hospital Complex, end of Keshavarz Boulevard, Tehran.
What processes are involved for a request to access data/document
After making the call(Phone, meet, Email) and providing the necessary documents(Written request), the documents or data files will reach the applicant.