The effect of mindfulness based stress reduction (MBSR) on CD4+ T Lymphocyte Count and Medical and Psychological Symptoms of HIV/AIDS infected patients referring to counseling center for behavioral diseases in Imam Khomeini Hospital, 2008
This study evaluated the immediate and longer-term effectiveness of the mindfulness-based stress reduction (MBSR) program on CD4+ T Lymphocyte Count and medical and psychological symptoms among HIV+ patients in Tehran, Iran. Using a randomized controlled trial, data were obtained from HIV+ patients not yet receiving antiretroviral therapy who participated in either an 8-week MBSR (n=85) or a brief education and support condition (ESC) (n=86) at the Imam Khomeini Hospital. Assessments included CD4 count, Symptom Checklist-90-Revised (SCL-90R), and Medical Symptom Checklist (MSCL) at baseline, immediate post-test, and 3, 6, 9 and 12-month follow-up periods.
General information
Acronym
MBSR2
IRCT registration information
IRCT registration number:IRCT201106084076N2
Registration date:2011-11-27, 1390/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-27, 1390/09/06
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-06-09, 1387/03/20
Expected recruitment end date
2011-06-10, 1390/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness based stress reduction (MBSR) on CD4+ T Lymphocyte Count and Medical and Psychological Symptoms of HIV/AIDS infected patients referring to counseling center for behavioral diseases in Imam Khomeini Hospital, 2008
Public title
The effect of mindfulness based stress reduction on HIV patients
Purpose
Treatment
Inclusion/Exclusion criteria
HIV positive patients were eligible to participate in the study if they had these conditions:
HIV+ confirmed by Western Blot,
CD4 >200,
Age>18, and
Age≤55,
patients were excluded if they had:
current substance addiction,
current psychosis,
history of post-traumatic stress disorder,
or if they had CD4 count under 200,
or were clinically symptomatic (e.g., herpes zoster, oral candidiasis, shingles, significant weight loss)
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
245
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods St
City
Tehran
Postal code
1148567
Approval date
2007-09-23, 1386/07/01
Ethics committee reference number
6503-55-04-86
Health conditions studied
1
Description of health condition studied
HIV infected people
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
CD4 lymphocyte count
Timepoint
Participants did CD4 count at pretest, immediate posttest, and 3, 6, 9 and 12 month post-intervention follow-up periods
Method of measurement
CD4 count was determined by flow cytometry
Secondary outcomes
1
Description
Medical Symptom Checklist (MSCL) which is a 115-item self-report measure of physical symptomatology that quantifies the number of common medical symptoms occurring in the previous month, and Symptom Checklist-90-Revised (SCL-90R) includes a 90-item self-report of mental health measured on a 5-point rating scale to assess a broad range of psychological problems and symptoms of psychopathology
Timepoint
Participants completed the self-report questionnaires at pretest, immediate posttest, and 3, 6, 9 and 12 month post-intervention follow-up periods
Method of measurement
MSCL and SCL-90R Questionnaires
Intervention groups
1
Description
Participants in the MBSR condition attended eight weekly group-based MBSR classes. MBSR is implemented in a class setting, in which sitting meditation, gentle mindful hatha yoga, a body scan meditation, and other approaches to cultivate mindfulness in everyday living are introduced. A psychologist who was formally trained in the MBSR program at the University of Massachusetts Center delivered the classes. In brief, session 1 and 2 consisted of a mindfulness body scan practice. Session 3 and 4 consisted of awareness of body postures via light Hatha yoga practices. Sessions 5 through 7 consisted of sitting mindfulness meditation. Session 8 consisted of a retreat lasting 6-7 hours, which incorporated all the practices learned in sessions 1 through 7. During the final session, a general discussion took place regarding encountering stress and how to apply MBSR techniques in daily life. Participants in control group received their usual clinical attention. Control group was provided with educational information and pamphlets about living healthy with HIV/AIDS. Education content focused on the following topics: 1) routes of HIV transmission, 2) HIV prevention, 3) facts and expectations about HIV drug therapy, and 4) maintaining positive behavior and cognitions while living with HIV. A psychologist was also available for the control group members during the intervention period to provide individual counselling.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Voluntary Counselling and Testing (VCT) centre of Imam Khomeini hospital
Full name of responsible person
Maryam Foroughi
Street address
Imam Khomeini hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran deputy of research/Shabnam Norouz zadeh
Street address
Keshavarz Blvd, Qods street
City
Tehran
Grant name
گرانت معاونت پژوهشی دانشگاه تهران
Grant code / Reference number
6503
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian research center for HIV/ AIDS
Full name of responsible person
Maryam Foroughi
Position
MD
Other areas of specialty/work
Street address
Imam Khomeini hospital , Keshavarz Blvd, valiasr sq, Tehran
City
Tehran
Postal code
11468654
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
Maryam.foroughi@ gmail.com
Web page address
Ircha.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Research center for HIV/ AIDS
Full name of responsible person
Minoo Mohraz
Position
MD, MPH, Infectious Disease Specialist
Other areas of specialty/work
Street address
Imam Khomeini hospital , Keshavarz . Blvd
City
Tehran
Postal code
11468546
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
minoomohraz@ams.ac.ir
Web page address
Ircha.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research center for HIV/AIDS
Full name of responsible person
Maryam Foroughi
Position
MD
Other areas of specialty/work
Street address
Imam Khomeini hospital, Keshavarz Blvd
City
Tehran
Postal code
11468546
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
Maryam.foroughi@gmail.com
Web page address
Ircha.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)