The effectiveness of mindfulness based cognitive group therapy on reducing depression and anxiety symptoms and improving quality of life in AIDS patients
Determining the Effectiveness of Mindfulness-Based Cognitive Group Therapy (MBCT) on Reducing Depression, Anxiety, and Improving Quality of Life
Design
This study is a pretest-posttest clinical trial with control group
Settings and conduct
Samples were randomly assigned to one of two experimental and control groups. The number of participants in both groups was 40 (20 female, 20 male). The participants in both the experimental and control groups (BDI Depression Inventory, Beck Anxiety Inventory BAI, and SF-36 Quality of Life Questionnaire) were simultaneously carried out At the Bu-Ali Center of the Shahid Beheshti University of Medical Sciences
Participants/Inclusion and exclusion criteria
Beck Depression Score (BDI) scores between 20 and over 40 (mild to severe) Beck Anxiety Score (BAI) Between 20 and Over 40 (Mild to Severely)
َAbility and willingness to participate in the study
Not having a particular speech and hearing problem
Having a minimum level of middle school education
Intervention groups
20 AIDS patients in the intervention group
20 AIDS patients in the control group
Main outcome variables
Depression, Anxiety, Quality of life
General information
Reason for update
Acronym
AIDS
IRCT registration information
IRCT registration number:IRCT20180312039056N1
Registration date:2018-06-12, 1397/03/22
Registration timing:registered_while_recruiting
Last update:2018-06-12, 1397/03/22
Update count:0
Registration date
2018-06-12, 1397/03/22
Registrant information
Name
Seyed Mojtaba Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 2222 3964
Email address
seyedmojtabaahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-04-09, 1397/01/20
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
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Scientific title
The effectiveness of mindfulness based cognitive group therapy on reducing depression and anxiety symptoms and improving quality of life in AIDS patients
Public title
The effectiveness of mindfulness based cognitive group therapy on reducing depression and anxiety symptoms and improving quality of life in AIDS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Beck Depression Score (BDI) scores between 20 and over 40 (mild to severe)
Beck Anxiety Score (BAI) Between 20 and Over 40 (Mild to Severely)
Power and willingness to participate in the study
Not having a particular speech and hearing problem
Having a minimum level of cycle education
Exclusion criteria:
Abuse or dependency to drug during treatment
The presence of symptoms of psychosis
TB disease
Age
From 24 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly assigned to one of two experimental and control groups, The number of participants in both groups was 20 (10 female, 10 male), At one time, the participants in both the experimental and control groups (BDI Depression Inventory, Beck Anxiety Inventory BAI, and SF-36 Quality of Life Questionnaire) were administered.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the intervention and control group were evaluated on different days and without knowledge of the program of the other group
Placebo
Not used
Assignment
Parallel
Other design features
Among all people with (AIDS) referred to the Behavioral Disease Counseling Center, which had conditions for group treatment (MBCT),40 male (male / female) patients who had entered the study based on entry criteria (age range from 24 to 50 years of non-addictive status, lack of tuberculosis) were available in a sampling method. Simple randomization was placed in one of the two experimental and control groups. The number of subjects in each of the experimental groups was 20 (10 female, 10 male) and 20 subjects (10 female, 10 male), At one time, for both experimental and control groups, a BDI depression questionnaire, BAI anxiety inventory and SF-36 quality of life questionnaire were used. After pre-test, MBCT treatment program was performed for 8 sessions for the experimental group and no program was performed for the control group during this period.One month after the end of the training sessions, in order to compare the effect of the intervention, both groups were tested and the results of the pre-test and post-test were compared for each group, Also, about the rules of participation in the research such as secrecy, observance of order and regular attendance at the training sessions, the participants were explained and the general trend of the program and training sessions was explained to them. After the end of the study, the control group performed 8 sessions of treatment.
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Academic Ethics Committee on Biomedical Research 170
Before and immediately after the intervention and one month after the end of the treatment
Method of measurement
Beck Depression Inventory
2
Description
anxiety
Timepoint
Before and immediately after the intervention and one month after the end of the treatment
Method of measurement
Beck Anxiety Inventory
3
Description
Quality of Life
Timepoint
Before and immediately after the intervention and one month after the end of the treatment
Method of measurement
Short-Form Health Survey Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive mindfulness based cognitive group therapy. The treatment includes eight weeks (one session per week for 45 minutes)..A guide to mindfulness based on cognitive-behavioral therapy of Segal et al. Was used. The content of each session is: Session 1: An Explanation of the Importance of Present Attendance and the Concept of Mindfulness for Patients Session 2: Body checkout, 10 minutes of mind-set on the respiratory flow, training for recording the desired events, exercising thoughts and feelings, defining emotions and identifying the positive and negative emotions. Session 3: Relax the wandering mind with breathing exercises and body browsing Session 4: Awareness of breathing, body, sounds and thoughts. Session 5: Complete awareness of thoughts and feelings and acceptance without judgment and direct intervention Session 6: Awareness of breathing, body, sounds and thoughts, communicating with your thoughts and feelings and expanding them, and accepting unwanted thoughts and emotions without judgment, discussing that thoughts are not reality. Session 7: Awareness of breathing, body, sounds and thoughts, understanding the relationship between activity and creation, providing a list of pleasurable activities and activities that feel the mastery of a person, 3 minutes of regular breathing space. Session 8: Planning for the future and using the techniques of being present to continue their lives and generalizing them to the whole life cycle.