Protocol summary

Study aim
Improve CD4; HIV / AIDS patients
Design
The present study was a semi-experimental applied study and a targeted sampling method was available. The sample size was 45 people in 3 groups of 15 and Sampling interstitial permutation block was used. To determine the subjects, the subjects were classified into 4 classes according to age category and sex in each category.
Settings and conduct
This research will be carried out on 45 HIV / AIDS patients at the Ahvaz Counseling Center for Behavioral Disease and will be treated for at least 16 weeks of psychological interventions. Each treatment group is 15 people. After coordination with the Center for Behavioral Disease Counseling, a telephone conversation will be held to convene psychological treatment sessions. Also, according to the treatment, the control group for each treatment group of 15 people is included in this study. It should be noted that, in certain medical conditions, consultation with the infectious clinic at the Counseling Center for Behavioral Diseases is required. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Follow up are considered.
Participants/Inclusion and exclusion criteria
entry : Age 25 to 50 years old, A resident of Ahwaz . Minimum education Ability to speak fluent persian. Minimum 350 CD4 patients. Exclusion criteria included: Taking psychosocial drugs . having addiction and suicidal thoughts.
Intervention groups
Subjects in the target group were closed for 8 sessions. The 45-minute meeting time is 16 weeks. Before the intervention and after that the questionnaire will be completed. Questionnaire is given to the control group before and after the intervention..
Main outcome variables
Quality of life, quality of life, perceived social support and changes in CD4 cells

General information

Reason for update
Acronym
HIV/AIDS
IRCT registration information
IRCT registration number: IRCT20190223042813N1
Registration date: 2019-09-02, 1398/06/11
Registration timing: retrospective

Last update: 2019-09-02, 1398/06/11
Update count: 0
Registration date
2019-09-02, 1398/06/11
Registrant information
Name
Shahla Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3558 5677
Email address
shahla_molavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-06, 1398/02/16
Expected recruitment end date
2019-06-06, 1398/03/16
Actual recruitment start date
2019-05-10, 1398/02/20
Actual recruitment end date
2019-06-10, 1398/03/20
Trial completion date
2019-09-11, 1398/06/20
Scientific title
The Comparison between of the Effectiveness of Cognitive-Behavioral Group Therapy ; Cognitive Therapy based on Mindfulness and combined therapy of Cognitive_ Behavioral /The recognition of the Therapy based on Mindfulness on Improving Sleep Quality, life Quality Perceived Social Support and Increase CD4 in Admitted HIV/AIDS
Public title
Effectiveness of Cognitive-Behavioral Group Therapy ; Cognitive Therapy based on Mindfulness and combined therapy of Cognitive_ Behavioral /The recognition of the Therapy based on Mindfulness on Improving Sleep Quality, life Quality Perceived Social Support and Increase CD4 in Admitted HIV/AIDS to Ahwaz City
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
. Age 25 to 50 years old A resident of Ahvaz Minimum cycle education . Ability to speak fluent persian. At least 350 CD4 patients
Exclusion criteria:
Having history of mental illness, depression mental disorder Taking psychosocial drugs Suicidal thoughts. Having addiction
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
An in-class randomized permutation block is used. Subjects are divided into 4 classes. The first floor is women 30 to 50 years old Second step women from 25 to 29 years old Third of men is 30 to 50 years old Fourth, 25-29 years According to the sample size of 15 people in each treatment group, 45 people were enrolled in the study and each floor is 15 people. A group of segments was coded in each class Group 1: Code 10, 11, 12 and ..................... The second group is code 20, 21, 22 and ............................ Group 3 code 30, 31, 32 and .............................. The fourth group code 40, 41, 42 and ...................... Then, randomization is done in the treatment of CBT, MBCT, combination of both treatment and control group. . We encode groups based on latin letters. A: CBT B: MBCT C: Combination of both treatments D: Control group We assign a number from 1 to 8 each. ABCD. ACBD BACD.BCAD. CABD.CBAD. DABC.DACB We use a random number table to construct. On each floor, one of the numbers 1, 2, 3, 4, 5, 6, 7, 8, it turned out that one of these blocks is selected, and if another number appears We take the absurd and go to the next selection and invite selected people in groups A, B, C and D to attend class meetings separately. For follow up, subjects will have 3-4 months of interventional therapy and a follow-up period of 2 months.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of AHVAZ branch Islamic Azad University
Street address
Angle Street Aboozar Children's Clinic. Ahvaz Behavioral Counseling Counseling Center
City
AHVAZ
Province
Khouzestan
Postal code
6187898434
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.IAU.AHVAZ.REC.1398.003

Health conditions studied

1

Description of health condition studied
HIV/AIDS
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases

Primary outcomes

1

Description
Quality of lifeand
Timepoint
It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered.
Method of measurement
questionnaire

2

Description
quality of life
Timepoint
It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered.
Method of measurement
questionnaire

3

Description
perceived social support
Timepoint
It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered.
Method of measurement
questionnaire

4

Description
changes in CD4 cells
Timepoint
It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered.
Method of measurement
Measuring the amount of cells cd4

Secondary outcomes

1

Description
Quality of life, quality of life, perceived social support and changes in CD4 cells
Timepoint
It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered.
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group one: The effectiveness of the Cognitive-Behavioral Therapy Group's Agenda Therapy (Tashabala, 2018) on stigma HIV AIDS that was modified by this guideline. This treatment was presented in 8 sessions, once a week, in 45-minute sessions based on the treatment protocol.
Category
Treatment - Other

2

Description
Intervention Group II: The Effect of Mindfulness-Based Cognitive Therapy on Aging Using Garcia, Boras, Lopez & McNeill 2016 for HIV, in which treatment is administered 8 sessions once a week for 45 minutes on a face-to-face basis. Treatment sessions were provided.
Category
Treatment - Other

3

Description
Intervention Group Three: Combined Cognitive-Behavioral Therapy / Mindfulness-Based Cognitive Therapy The combination of the Cognitive Behavioral Therapy Meeting Agenda (Tashabala, 2018) and the Mindfulness-Based Cognitive Therapy Agenda (Garcia et al., 2016) are both therapeutic approaches. Meetings are held once a week in 45-minute sessions.
Category
Treatment - Other

4

Description
control group: . Also, according to the treatments performed in the control group for each treatment group or 15-person treatment intervention in this study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
. Behavioral Disease Counseling Center
Full name of responsible person
Shahla Molavi
Street address
Angle Street Children's Clinic. Behavioral Disease Counseling Centerش
City
ahvaz
Province
Khouzestan
Postal code
6187898434
Phone
+98 61 3445 4600
Fax
+98 61 3445 4600
Email
shahla_molavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hosain Matori
Street address
Angle Street Children's Clinic. Behavioral Disease Counseling Center
City
ahvaz
Province
Khouzestan
Postal code
6187898434
Phone
+98 61 3445 4600
Fax
+98 61 3445 4600
Email
shahla_molavi@yahoo.com
Grant name
zero
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
shahla molavi
Position
Masters of Consultation
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Angle Street Children's Clinic. Behavioral Disease Counseling Center
City
Ahvaz
Province
Khouzestan
Postal code
6187898434
Phone
+98 61 3445 4600
Fax
+98 61 3445 4600
Email
shahla_molavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
shahla molavi
Position
Masters of Consultation
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Zawei Street, Children's Health Center. Behavioral Diseases Center
City
ahvaz
Province
Khouzestan
Postal code
6187898434
Phone
+98 61 3445 4600
Fax
+98 61 3445 4600
Email
shahla_molavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
shahla molavi
Position
Masters of Consultation
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Zawei Street, Children's Health Center. Behavioral Diseases Center
City
Ahvaz
Province
Khouzestan
Postal code
6187898434
Phone
+98 61 3445 4600
Fax
+98 61 3445 4600
Email
shahla_molavi@yahoo.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
It is not decided
Study Protocol
No - There is not 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
No - There is not 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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