IRCT | Investigating the effectiveness of brief acceptance and commitment therapy (ACT) on reducing the symptoms of depression, anxiety, stress, rumination and worry, and increasing the quality of life and the number of CD4 lymphocytes in people with HIV.

Protocol summary

Study aim: Investigating the effectiveness of short-term acceptance and commitment therapy (ACT) on reducing the symptoms of depression, anxiety, stress, rumination and worry, and increasing the quality of life and the number of CD4 lymphocytes in people with HIV
Design: This study is a single-blind clinical trial, and the sample collection method is available. 60 people are selected in two groups of 30 including the intervention group (four-session form of acceptance and commitment therapy in the form of 60 to 90-minute sessions that are conducted individually once a week by a PhD student in clinical psychology The observed course will be implemented for them under the supervision of the supervisor) and the control group will be replaced. Allocation of people to two groups will be in the form of block randomization which will be done by RANDOM ALLOCATION SOFTWARE after the completion of the treatment sessions and also at the end of each period of follow-up (2-6-12 months), the questionnaires will be re-implemented.
Settings and conduct: Imam Khomeini Hospital, Iran AIDS Study Center
Participants/Inclusion and exclusion criteria: Inclusion criteria: having informed consent to participate in the research and sign a written consent form; age over 18 years old; not having an active addiction; not suffering from severe psychiatric disorders; score equal to or above 9 in the PHQ-9 questionnaire. Exit criteria: receiving other treatments at the same time; report suicidal thoughts or intent; absence of more than 3 consecutive sessions; taking psychotropic drugs; unwillingness to participate in treatment.
Intervention groups: People with HIV who are under the care of Iran AIDS Study Center are treated with four sessions of ACT. To achieve the goal of a full, rich and meaningful life
Main outcome variables: Improving quality of life and reducing symptoms related to mental health

General information

Reason for update
Acronym: HIV-ACT
IRCT registration information: IRCT registration number: IRCT20230809059103N1

Registration date: 2023-09-28, 1402/07/06

Registration timing: prospective

Last update: 2023-09-28, 1402/07/06

Update count: 0
Registration date: 2023-09-28, 1402/07/06

Registrant information: Name

farshad aliyari

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 6562 3484

Email address

farshadaliyari98@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-10-22, 1402/07/30
Expected recruitment end date: 2024-02-19, 1402/11/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effectiveness of brief acceptance and commitment therapy (ACT) on reducing the symptoms of depression, anxiety, stress, rumination and worry, and increasing the quality of life and the number of CD4 lymphocytes in people with HIV.

Public title: Investigating the effectiveness of brief acceptance and commitment therapy (ACT) on reducing the symptoms of depression, anxiety, stress, rumination and worry, and increasing the quality of life and the number of CD4 lymphocytes in people with HIV.
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Having informed consent to participate in the research and sign a written consent form Age over 18 years Not having an active addiction Not suffering from severe psychiatric disorders A score equal to or above 9 in the PHQ-9 questionnaire

Exclusion criteria:

Receiving other treatments at the same time Report suicidal thoughts or intent Absence of more than 3 consecutive sessions Taking psychotropic drugs Unwillingness to participate in treatment
Age: From 18 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Allocation of people to two groups will be done by block randomization, which will be done by RANDOM ALLOCATION SOFTWARE, in this method, both groups will have the same number of subjects, which will minimize the effect of confounding variables.

Blinding (investigator's opinion)

Single blinded

Blinding description

The participants will not be aware of their allocation to the control and experimental groups, and the people who are in the control group will be told that your intervention (according to the time required to perform interventions on the experimental group) will begin some time later.

Placebo

Not used

Assignment

Other

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Shahid Beheshti University of Medical Sciences

Street address

Faculty of Medicine - Shahid Beheshti University of Medical Sciences

City

tehran

Province

Tehran

Postal code

193954631
Approval date: 2023-07-24, 1402/05/02
Ethics committee reference number: IR.SBMU.MSP.REC.1402.210

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: Symptoms of depression, anxiety, stress,
Timepoint: The beginning and end of the study, TWO months later, six months later and twelve months later
Method of measurement: .Depression: the score that a person gets in the depression subscale of the DAAS questionnaire.Anxiety: the score that a person gets in the anxiety subscale of the DAAS questionnaire.Stress: the score that a person gets in the stress subscale of the DAAS questionnaire.

2

Description: Quality of life
Timepoint: The beginning and end of the study, TWO months later, six months later and twelve months later
Method of measurement: (WHO-QOL-BRIEF)

3

Description: Worry
Timepoint: The beginning and end of the study, TWO months later, six months later and twelve months later
Method of measurement: PSWQ

4

Description: Rumination
Timepoint: The beginning and end of the study, TWO months later, six months later and twelve months later
Method of measurement: (RRS)

5

Description: CD4 lymphocytes
Timepoint: The beginning and end of the study, TWO months later, six months later and twelve months later
Method of measurement: CD4 count by flow cytometry and complete blood count will be determined by a licensed clinical laboratory in Imam Khomeini Hospital.

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: this group is subjected to the same four session ACT treatment intervention
Category: Treatment - Other

2

Description: Control group: After the intervention group, they are subjected to the same treatment measures.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Khomeini Hospital, Iran AIDS Study Center

Full name of responsible person

DR. SEYED AHMAD SEYED ALINAGHI

Street address

Imam Khomeini Hospital

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 0000

Email

s.a.alinaghi@gmail.com

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Dr. Abbas Masjedi

Street address

shahid beheshti medical science university

City

Tehran

Province

Tehran

Postal code

1985711151

Phone

+98 21 2243 9945

Email

sbmu@sbmu.ac.ir

Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Private
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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Amirsam Kiani Moghadam

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Taleghani Hospital, Arabi Street, Velenjak

City

Tehran

Province

Tehran

Postal code

1985711151

Phone

+98 21 2243 2560

Email

as.kianimoghadam@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Amirsam Kiani Moghadam

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Taleghani Hospital, Arabi Street, Velenjak

City

Tehran

Province

Tehran

Postal code

1985711151

Phone

+98 21 6562 3484

Email

as.kianimoghadam@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Amirsam Kiani Moghadam

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Taleghani Hospital, Arabi Street, Velenjak

City

Tehran

Province

Tehran

Postal code

1985711151

Phone

+98 21 6562 3484

Email

as.kianimoghadam@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: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: results will be published in the article that will be written after finishing the thesis.
When the data will become available and for how long: After finishing the thesis and writing the article
To whom data/document is available: researchers
Under which criteria data/document could be used: Researchers who research HIV treatment
From where data/document is obtainable: National Center for AIDS Studies
What processes are involved for a request to access data/document: The request should be sent to the deputy of the research center, Dr. Ali Naghi, via email and will be reviewed by him.
Comments

Investigating the effectiveness of brief acceptance and commitment therapy (ACT) on reducing the symptoms of depression, anxiety, stress, rumination and worry, and increasing the quality of life and the number of CD4 lymphocytes in people with HIV.