The effectiveness of combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy on cognitive functions, emotional problems and quality of life of HIV patients with associated neurocognitive disorders.
The effectiveness of combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy on cognitive functions, emotional problems and quality of life of HIV patients with associated neurocognitive disorders.
Design
Interventional - Randomized Control Clinical Trial (Census Method) Using G power software, the number of subjects is estimated and randomization is done by software.
Settings and conduct
Patients will be randomly assigned into three groups (the first experimental group, the second experimental group and the control group). Classification will be done by the secretary of the center who is unaware of the type of intervention for each group.(Census method).Patients will be randomly assigned into three groups (experimental group 1, experimental group 2 and control group).Classification will be done by the secretary of the center who is unaware of the type of intervention for each group
Participants/Inclusion and exclusion criteria
-Receiving antiretroviral therapy for at least 6 months
-Plasma HIV- RNA lesser or equal to 50 cells in one mililiter for at least 6 months
-Number of lymphocytes +T CD4 less than 350 cells in 1 microliter for at least six months
- No severe associated diseases such as neurodevender disease or
Psychiatric disease, metabolic encephalopathy, use of psychotropic drugs or head trauma
Intervention groups
In experimental group 1, cognitive rehabilitation therapy is performed 12 sessions of one hour twice a week
In experimental group 2, integrated cognitive rehabilitation therapy such as the first group and emotion regulation therapy based on dialectical behavior therapy will be performed in 8 two-hour sessions (twice a week)
In the control group, there is no treatment and only the usual treatments are received
Main outcome variables
Cognitive Functions
Emotional problems
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211118053093N2
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Kimia Sahraian
Name of organization / entity
Eghlid Higher Education Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3886
Email address
leilarazeghian1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-20, 1400/09/29
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy on cognitive functions, emotional problems and quality of life of HIV patients with associated neurocognitive disorders.
Public title
combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy in HIV patients with associated neurocognitive disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving antiretroviral therapy for at least 6 months
Plasma HIV- RNA lesser or equal to 50 cells in one mililiter for at least 6 months
Number of lymphocytes +T CD4 less than 350 cells in 1 microliter for at least six months
Proficiency in Persian
Informed consent
Exclusion criteria:
neurodegenerative diseases
severe psychiatric disorder
metabolic encephalopathy
use of psychotropic drugs
head trauma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in all three groups do not know what intervention will be made for them.
Researcher and analyst also has no knowledge of which person is in which group
Placebo
Used
Assignment
Parallel
Other design features
In this study, it is assumed that if cognitive rehabilitation interventions and psychological interventions such as emotion regulation based on dialectical behavior therapy are used as a combination, applied and supportive therapeutic approach along with pharmacotherapy, due to the chronicity of this disease, the therapeutic effects will be long and profound and will lead to improvement of cognitive function and emotional problems and increasing the quality of life in these people.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shiraz University of Medical Sciences
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71444113331
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.SUMS.MED.REC.1400.488
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Quality of life of HIV patients with associated neurocognitive disorders.
Timepoint
Before treatment End of treatment Four months after treatment
Method of measurement
Quality of Life Questionnaire
2
Description
Cognitive Function
Timepoint
Before treatment End of treatment Four months after treatment
Method of measurement
Cognitive Function Questionnaire
3
Description
Emotional problems
Timepoint
Before treatment End of treatment Four months after treatment
Method of measurement
Emotional Problems Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group 1:" Cognitive rehabilitation 12 sessions one hour, twice a week Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education
Category
Treatment - Other
2
Description
"Intervention group 2:" 1.emotion regulation based on dialectic behavioral therapy and 2.emotion regulation based on dialectic behavioral therapy eight two-hour sessions twice a week. Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education Session13 and14:They will learn to view and describe their emotional experiences without judgment and to validate their emotions. Session15:Self-assessment or observation of emotions Session16: Performing different mindfulness exercises Session17:Training discomfort tolerance skills Session18: Training emotional relief skills Session19:Training positive excitement skills Session20: Reassessment and planning for the application of education
Category
Treatment - Other
3
Description
"Control group:" routine daily therapy without psychotherapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral Diseases Center of Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Leila razeghian Jahromi
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
asisstant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.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