The Effect of Group Dialectical Behavior Therapy (DBT) on Covid-19 Caused Anxiety and its Complications on Mental Health in Adults Living in Pishva City.
Determining the effect of group Dialectical Behavior Therapy (DBT) on covid-19 caused anxiety and its complications on mental health in adults living in Pishva city.
Design
A clinical trial with intervention and control group, randomization by lottery, a sample size of 60.
Settings and conduct
The place and the method of study: The statistical population of this paper includes individuals aged 19 to 45 living in the city of Peshwa who are infected with Covid-19 in 2021-2022. This paper is a randomized controlled trial using a pre-test-post-test design with a control group receiving usual care. It is standard research. The intervention will be done at the Gholamreza Arab Salmani center located in Pishva city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Covid-19 infected based on CPR test; adults in the age range of 19 to 45 years; adults living in Pishva city. Exclusion criteria:
Dissociative psychotic disorders, drug and alcohol abuse; having underlying diseases such as cancer; mental retardation disorders; the presence of psychotic disorders.
Intervention groups
Intervention group: they will undergo eight 2-hour sessions of intervention once a week. Control group: there will be no intervention.
Main outcome variables
Corona anxiety; depression; aggression; sleep quality; mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220902055850N1
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Zahra Kouhivardehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3672 4801
Email address
hasti.ham@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Dialectical Behavior Therapy (DBT) on Covid-19 Caused Anxiety and its Complications on Mental Health in Adults Living in Pishva City.
Public title
The Effect of Group Dialectical Behavior Therapy (DBT) on Covid-19 Caused Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-19 infected based on CPR test
Adults in the age range of 19 to 45 years
Adults living in Pishva city
Exclusion criteria:
Dissociative psychotic disorders,
Drug and alcohol abuse
Having underlying diseases such as cancer
Mental retardation disorders
The presence of psychotic disorders
Age
From 19 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a number of 60 subjects are selected according to similar research by convenience sampling method. Then, a random replacement is done by the random draw method so that each subject is assigned a number and we write down the numbers on the paper, then fold them and put them in a container. Later on, we mix the papers and take out the papers one by one and place one number in the first group and one number in the second group, respectively. Then random assignment will be done. In this way, one group will be assigned as the control group and the other group will be assigned as the intervention group by putting each group in an envelope and randomly taking out one envelope from the container and assigning it to the intervention group and the other envelope to the control group.
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 Semnan Islamic Azad University
Street address
Islamic Azad University of semnan, shahrak daneshgahi
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.034
Health conditions studied
1
Description of health condition studied
Anxiety disorder, unspecified
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Covid-19 caused anxiety: the score obtained from the coronavirus anxiety scale questionnaire prepared by Alipour, Abdullahzadeh, and Gadami (2019).
Timepoint
The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention).
Method of measurement
Corona anxiety scale questionnaire
2
Description
Mental Health: The score obtained from the General Health Questionnaire (GHQ-28) was first adjusted by Goldberg (1972, citing Taqvi 2018).
Timepoint
The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention).
Method of measurement
Goldberg mental health questionnaire
3
Description
Depression: the score obtained from the Depression, Anxiety, Stress Scale (DASS) questionnaire prepared by Alvibond, (5991)
Timepoint
The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention).
Aggression: the score obtained from the Aggression Questionnaire (Buss & Perry, 1992)
Timepoint
The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention).
Method of measurement
Bass and Perry Aggression Questionnaire
5
Description
Sleep quality: the score obtained from the Pittsburgh Sleep Quality Index (PSQI). This questionnaire was developed in 1989 by Dr. Boyce and his colleagues at the Pittsburgh Psychiatric Institute.
Timepoint
The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention).
Method of measurement
Pittsburgh Sleep Quality Questionnaire (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group will undergo eight 2-hour sessions of group Dialectical behavior therapy (DBT) once a week. The treatment package used in this research will be derived from the group Dialectical behavior therapy (DBT) method derived from Linehan. The first session: First, the time of the sessions will be set, then the necessary explanations will be given to the subject regarding the rules and regulations of each session, followed by descriptions of the principles and methods of thinking and behavior in dialectical ways, and familiarity with mindfulness, rational mind, emotion mind, and wise mind. And then the subjects will be provided with explanations about the main goal of DBT, which is to learn how to live in the moment and develop healthy ways to cope with stress, control their emotions and improve their relationships. At the end of the session, assignments will be given to the subjects.The second session: First, the assignments of the previous session will be reviewed, and then the distress tolerance skill will be explained to subjects to equip them with the ability to cope with themselves and the current situation. Also, basic skills of coping with disturbance, including different methods of diverting attention from self-harming behaviors, diverting attention through pleasurable activities, diverting attention to work or another subject, leaving the situation, etc., will be taught. Then we will draw up a plan for returning the attention, and self-relaxation, drawing up a relaxation plan, and at the end of the session, assignments will be given to the subjects.The third session: At the beginning of the session, the exercises of the previous session will be reviewed, and then in this session, advanced skills of distress tolerance, will be trained including imaging from a safe place, discovering values, living in the present, radical acceptance, developing new coping strategies, and developing a coping plan for the necessary situation. At the end of the session, assignments will be given to the subjects for the next session.The fourth session: At the beginning of the session, the exercises given in the previous session will be reviewed, and then the importance of mindfulness will be explained to the subjects. Mindfulness can help people to focus on the present and live in the moment, and this helps them to pay attention to what is going on inside them, and they will be taught basic skills of mindfulness, such as practicing inattention.The fifth session: At the beginning of the session, the assignments of the previous session will be reviewed, and in this session, advanced mindfulness skills including radical acceptance, beginner's mind, judgments and labels, non-judgment of conscious communication with others, daily schedule for mindfulness, awareness of obstacles to the implementation of exercises will be taught. At the end of the session, assignments will be given to the subjects for the next session.The sixth session: At the beginning of the session, the assignments of the previous session will be reviewed, then emotional regulation will be explained to the subjects. people can cope more effectively with strong emotions by regulating their emotions. The acquired skills help people identify, name, and change their feelings. We will teach basic and advanced skills such as emotions and how they work, emotional regulation skills, overcoming obstacles to healthy emotions, reducing physical vulnerability to emotions, increasing positive emotions, dealing with emotions, and solving problems. At the end of the session, assignments will be given to the subjects for the next session.The seventh session: At the beginning of the session, the assignments of the previous session will be reviewed, then effective communication will be explained to subjects it is said that interpersonal effectiveness helps them to be more assertive in relationships by maintaining a positive and healthy relationship (for example, being able to express themselves and say no). They will learn to listen and communicate better. In this regard, the basic skills of effective communication such as passive-aggressive behavior, compatibility of my desires and theirs, the ratio of wants and needs, skills training, key interpersonal skills, and barriers to using interpersonal skills will be taught and at the end of the session, assignments will be given to the subjects for the next session. The eighth session: At the beginning of this session, the assignments of the previous session will be reviewed, and then advanced skills of effective communication such as identifying goals, adjusting the intensity of goals, boldness scripts, courageous listening, saying no, how to negotiate, how to analyze interpersonal problems will be taught. And at the end of the session, assignments will be given to the subjects for the next session.
Category
Treatment - Other
2
Description
Control group: no intervention is done for the control group. One week before the intervention, a pre-test was taken from the control group and they are placed on the waiting list. At the end of the intervention, they will be given a post-test and the results will be analyzed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholamreza Arab Salmani Consulting Office
Full name of responsible person
Gholamreza Arab Salmani
Street address
Pishva, Shariati St., in front of the governorate of Toranj building, first floor, No. 69 Postal code: 3381833586
City
Pishva
Province
Tehran
Postal code
3381833586
Phone
+98 21 3672 7194
Email
reza9431@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Karim sohrabi
Street address
Islamic Azad Univercity of Semnan Shahrak Daneshgahi
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Fax
+98 23 3365 4036
Email
amir_sohraby@aut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zahra Kouhivar Dehkordi
Position
Dtudy University
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.6, seylsepour al., 22Bahman ST., Shohada SQ., Rah ahan BLVD., Pishva Town., Tehran Province