Protocol summary

Study aim
Determining the effect of cognitive therapy based on mindfulness on the happiness of women with HIV
Design
Pre-post-test trial, follow-up with control group, with parallel groups, randomized
Settings and conduct
The sample of HIV-positive women referred to the center of high-risk diseases in Ahvaz, who were selected from among the research community and have low happiness, the total number of participants is 92, with 46 in each group. The intervention is carried out as a pre-test, post-test and follow-up stage, so that the intervention group completes the self-reported happiness questionnaire at the beginning of the study, immediately after completion and 8 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: HIV-positive women, willingness to participate in research, obtaining a score of less than 42 from the happiness questionnaire, age between 20-45 years. Inclusion criteria: suffering from moderate or severe depression according to the Beck depression questionnaire (score higher than 18), taking antidepressants, consuming alcohol and psychoactive substances by the patient, simultaneously benefiting from counseling and other educational services in order to increase happiness and well-being, major stressors in the last 3 months.
Intervention groups
The intervention and control group includes HIV positive women with low happiness, during 8 group counseling sessions (one session per week), with the cognitive therapy approach based on mindfulness with the aim of improving happiness. The control group received no intervention.
Main outcome variables
happiness; Life satisfaction ; Self-esteem ; positive mood; the health ; Efficiency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231004059614N1
Registration date: 2023-10-12, 1402/07/20
Registration timing: prospective

Last update: 2023-10-12, 1402/07/20
Update count: 0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Nahid Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3445 5959
Email address
nahid.asadi.mid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based cognitive therapy on the happiness of women with HIV
Public title
The effectiveness of mindfulness-based cognitive therapy on the happiness of women with HIV
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent and informed desire to participate in the research Ability to participate in meetings and cooperate in doing assignments Physical and psychological stability (not having obvious physical or psychological symptoms that interfere with participation in meetings, such as fatigue, muscle pain, etc.) Having at least reading and writing literacy Obtaining a score less than 42 from the happiness questionnaire Age range between 20 and 45 years Having a test (rapid test or ELISA) that shows that the person is HIV positive One year has passed since the person was infected with HIV
Exclusion criteria:
The presence of acute and severe symptoms of the disease in a way that makes it difficult or almost impossible for the patient to participate in the present study Suffering from moderate or severe depression according to the Beck depression questionnaire (getting a score higher than 18 Taking antidepressants consumption of alcohol and psychoactive substances by the patient بهره مندی همزمان از مشاوره و خدمات آموزشي ديگر در جهت افزايش شادکامی و بهزیستی Major stressors in the last 3 months such as loss of loved ones and divorce
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The current research will be a clinical trial study that will be conducted with the aim of determining the effectiveness of cognitive therapy based on mindfulness on the happiness of women with HIV. After obtaining the code of ethics and registration in the clinical trial center, and obtaining the letter of recommendation, the researcher will visit the high-risk disease center in Ahvaz in person to collect the samples. Using targeted sampling, samples will be selected from women who are eligible and who meet the entry criteria and do not have the exit criteria. Due to the lack of presence of all women in the center at the same time, the researcher will conduct the sampling both in person and from the files registered in the center in such a way that he will extract the contact numbers of the people from the file and firstly about the objectives of the research and how The intervention will give the same explanation to each eligible person and ask for written consent from the eligible people. Completing the demographic, depression and happiness questionnaire will be done by the samples who meet the conditions for entering the study (the researcher will be present at the center and if the participants have any questions, he will answer their questions). One of the conditions for entering the study is to score less than 42 in the happiness questionnaire total number of participants in the study will be 92 people based on statistical calculations, and 46 people will enter the research in each group. After the initial selection of the samples, the method of assigning people to the control and test groups will be randomly and blocks of four (using the table of random permutations). After determining the size of the block, which is 4 in this study, a list of blocks (23 blocks of 4) will be prepared and numbers will be assigned to them, then random numbers between 1 and 6 will be selected (1) AABB, ( 2) ABAB, (3) ABBA, (4) BBAA, (5) BABA, (6) BAAB). Due to the nature of this study, it will not be possible to blind the researcher and the participant. Since the sample size of people in the mindfulness treatment group should not exceed 14 people, because the effectiveness of psychotherapy decreases with the increase in the number of groups, so the intervention group was divided into 4 groups (2 groups of 11 people and 2 groups of 12 people) ) will be divided, then the intervention will be implemented in the form of 8 counseling sessions and a follow-up phase (8 weeks after the end of the counseling sessions) so that all women in both groups (intervention and control) at the beginning and immediately after the intervention and 8 weeks (39) After the end of the intervention, they will complete the happiness questionnaire in the form of self-reporting. Counseling will be done by a trained researcher (the researcher will participate in a three-day mindfulness workshop and receive a certificate) under the supervision of the respected scientific advisor at the center. The women of the intervention group will undergo 8 group counseling sessions (one session per week) with a cognitive therapy approach based on mindfulness with the aim of improving happiness. The content of the sessions will be compiled using the book "Mindfulness-Based Interventions in the Context: Past, Present and Future" written by Kabat Zain and under the supervision of the scientific advisor of the research. Group meetings, one 90-minute meeting per week will be held between the counselor and the clients according to the schedule. Considering that the control group will not receive any intervention despite the low happiness, in order to comply with the ethical standards, after completing the study, they will be given a training booklet and a summary of the contents of the sessions.
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 Jundishapur University of Medical Sciences
Street address
Golestan Street, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.AJUMS.REC.1402.344

Health conditions studied

1

Description of health condition studied
Human immunodeficiency virus [HIV] disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
happiness
Timepoint
At the beginning and immediately after the end of the intervention and 8 weeks after the end of the intervention
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Using targeted sampling, samples will be selected from women who are eligible and who meet the entry criteria and do not have the exit criteria. Due to the lack of presence of all women in the center at the same time, the researcher will conduct the sampling both in person and from the files registered in the center in such a way that he will extract the contact numbers of the people from the file and firstly about the objectives of the research and how The intervention will give the same explanation to each eligible person and ask for written consent from the eligible people. Completing the demographic, depression and happiness questionnaire will be done by the samples who meet the conditions for entering the study (the researcher will be present at the center and if the participants have any questions, he will answer their questions). One of the conditions for entering the study is to score less than 42 in the happiness questionnaire. The total number of participants in the study will be 92 people based on statistical calculations, and 46 people will enter the research in each group. After the initial selection of the samples, the method of assigning people to the control and test groups will be randomly and blocks of four (using the table of random permutations). After determining the size of the block, which is 4 in this study, a list of blocks (23 blocks of 4) will be prepared and numbers will be assigned to them, then random numbers between 1 and 6 will be selected (1) AABB, ( 2) ABAB, (3) ABBA, (4) BBAA, (5) BABA, (6) BAAB). Due to the nature of this study, it will not be possible to blind the researcher and the participants. Since the sample size of people in the group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with the increase in the number of groups, so the group The intervention will be divided into 4 groups (2 groups of 11 people and 2 groups of 12 people), then the intervention will be implemented in the form of 8 counseling sessions and a follow-up phase (8 weeks after the end of the counseling sessions) so that all the women of both groups ( intervention and control) at the beginning and immediately after the end of the intervention and 8 weeks (39) after the end of the intervention, they will complete the happiness questionnaire in the form of self-reporting. Counseling will be done by a trained researcher (the researcher will participate in a three-day mindfulness workshop and receive a certificate) under the supervision of the respected scientific advisor at the center. The women of the intervention group will undergo 8 group counseling sessions (one session per week) with a cognitive therapy approach based on mindfulness with the aim of improving happiness. The content of the sessions will be compiled using the book "Mindfulness-Based Interventions in the Context: Past, Present and Future" written by Kabat Zain and under the supervision of the scientific advisor of the research (46). Group meetings, one 90-minute meeting per week will be held between the counselor and the clients according to the schedule.
Category
Other

2

Description
Control group: Considering that the control group will not receive any intervention despite the low happiness, in order to comply with the ethical standards, after completing the study, they will be given a training booklet and a summary of the contents of the sessions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz high-risk diseases center
Full name of responsible person
Shahla Molavi
Street address
Zaytoun Karmani - Zawiya Street - next to Abu Dhar Hospital - in front of Hedayat Alley - upper floor of children's clinic
City
Ahvaz
Province
Khouzestan
Postal code
5587774144
Phone
+98 61 3445 4600
Fax
Email
fgnrfrd@ygug.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Street address
Golestan Blvd., Esfand St., Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8385
Email
mousavi-p@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid asadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur university of medical sciences, Esfand Ave.,Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8538
Email
nahid.asadi.mid@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
Midwifery instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur university of medical sciences, Esfand Ave.,Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8385
Email
mousavi-p@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid ASADI
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Jundishapur university of medical sciences, Esfand Ave.,Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8538
Email
nahid.asadi.mid@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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