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The effect of Acceptance and Commitment Therapy (ACT) on Mindfulness Skills , Thought Suppression , Thought Control , Inflexibility , And Valued living Among HIV Infected patients .

Protocol summary

Summary
This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on mindfulness skills, thought suppression, thought control, inflexibility and valued living in patients with AIDS in Tehran. A Pretest-Posttest, two-group, quasi-experimental design is used as the research method. The study population consist of AIDS patients who referred to the clinic of research center for HIV/AIDS and sexually transmitted diseases in Imam Khomeini hospital in fall/winter 2015-16, of which 30 volunteers ( who meet the inclusion criteria, consist of: being HIV positive and consent to participate; being in age range of 30 to 58 years old) are selected and randomly divide into control and experimental groups. The questionnaire of Kentucky Inventory of Mindfulness Skills (used by Baer et al., 2004), the questionnaire of thought suppression (used by Schmidt et al., 2009), thought control questionnaire (used by Luciano et al., 2009), the inflexibility questionnaire (used by Bond et al., 2003) and valued living questionnaire (used by Wilson et al., 2010), are applied as the research tools. Data will be analyzed by Statistical Package for the Social Sciences (SPSS ver. 21).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509224076N17
Registration date: 2015-11-02, 1394/08/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-02, 1394/08/11
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
Vice chancellor for research, Tehran university of medical sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acceptance and Commitment Therapy (ACT) on Mindfulness Skills , Thought Suppression , Thought Control , Inflexibility , And Valued living Among HIV Infected patients .
Public title
The effect of Acceptance and Commitment Therapy on HIV Infected patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being HIV positive and consent to participate; being in age range of 30 to 58 years old. Exclusion criteria: Participants are excluded if they do not meet the inclusion criteria
Age
From 30 years old to 58 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd, Valiasr Sq Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
IR.TUMS.REC.1394.276

Health conditions studied

1

Description of health condition studied
HIV AIDS
ICD-10 code
B24
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases

Primary outcomes

1

Description
Mindfulness Skills
Timepoint
Before intervention and 6 months after intervention
Method of measurement
The questionnaire of Kentucky Inventory of Mindfulness Skills

Secondary outcomes

1

Description
Thought Suppression
Timepoint
Before intervention and 6 months after intervention
Method of measurement
The questionnaire of thought suppression (used by Schmidt et al.)

2

Description
Thought Control
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Thought control questionnaire (used by Luciano et al.)

3

Description
Inflexibility
Timepoint
Before intervention and 6 months after intervention
Method of measurement
The inflexibility questionnaire (used by Bond et al.)

4

Description
Valued living
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Valued living questionnaire (used by Wilson et al.)

Intervention groups

1

Description
Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on mindfulness skills, thought suppression, thought control, inflexibility and valued living in patients with AIDS in Tehran. A Pretest-Posttest, two-group, quasi-experimental design is used as the research method. The study population consist of AIDS patients who referred to the clinic of research center for HIV/AIDS and sexually transmitted diseases in Imam Khomeini hospital in fall/winter 2015-16, of which 30 volunteers ( who meet the inclusion criteria, consist of: being HIV positive and consent to participate; being in age range of 30 to 58 years old) are selected and randomly divide into control and experimental groups. The questionnaire of Kentucky Inventory of Mindfulness Skills (used by Baer et al., 2004), the questionnaire of thought suppression (used by Schmidt et al., 2009), thought control questionnaire (used by Luciano et al., 2009), the inflexibility questionnaire (used by Bond et al., 2003) and valued living questionnaire (used by Wilson et al., 2010), are applied as the research tools.
Category
Treatment - Other

2

Description
Control group: there are not any intervention in this group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Triangular clinic for sexual and behavioral disease.
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciences
Full name of responsible person
Dr Younesian
Street address
Ghods Avn , Keshavarz Blvd Tehran, Iran, Islamic Republic O
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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 (IRCHA)
Full name of responsible person
Minoo Mohraz MD
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ircha@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian research center for HIV AIDS
Full name of responsible person
Minoo Mohraz MD
Position
Professor
Other areas of specialty/work
Street address
Iranian research center for HIV AIDS, Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Farzaneh Vakil Ghahani
Position
Msc
Other areas of specialty/work
Street address
Iranian research center for HIV AIDS, Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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