Comparison of effectiveness of cognitive-behavioral therapy and therapy based on commitment and acceptance on coping strategies with stress, feeling of psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatmen
Comparison of the effectiveness of cognitive-behavioral therapy with commitment-based therapy and acceptance on coping strategies with stress, psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatment.
Design
The clinical trial will be conducted with two intervention groups and one control group, with 20 people in each group, with random grouping.
Settings and conduct
As stated, this study will be conducted in three groups of 20 people (two intervention groups and one control group) from among addicted couples undergoing treatment in addiction treatment centers in Kerman city, which were randomly selected as available samples. Lotteries are placed in test groups. Then, in 12 intervention sessions, two groups are taught the principles and techniques of cognitive behavioral therapy and commitment-based therapy. The third group enters the post-test stage without the slightest intervention along with the two intervention groups.
Participants/Inclusion and exclusion criteria
Low score in the problem-oriented coping strategies questionnaire; Low score on the couple intimacy questionnaire; Low score on the Mental Cohesion Questionnaire; Absence of psychotic and paranoid disorders in subjects; Receive voluntary and informed consent; At least a year has passed since their addiction; People addicted to methadone maintenance treatment; Have at least a diploma
Intervention groups
First intervention group: cognitive behavioral therapy; The second intervention group: treatment based on commitment and acceptance; Control group: no training to subjects
Main outcome variables
strategies to deal with stress; psychological coherence; Intimacy of couples
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220520054933N1
Registration date:2022-08-19, 1401/05/28
Registration timing:retrospective
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
saleh ghiasi nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 4448
Email address
saleh.g1992@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of cognitive-behavioral therapy and therapy based on commitment and acceptance on coping strategies with stress, feeling of psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatmen
Public title
Comparison of effectiveness of cognitive-behavioral therapy and therapy based on commitment and acceptance on coping strategies with stress, feeling of psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Low score in the problem-oriented coping strategies questionnaire
Low score on the couple intimacy questionnaire
Low score on the Mental Cohesion Questionnaire
Absence of psychotic and paranoid disorders in subjects
Receive voluntary and informed consent
At least a year has passed since their addiction
People addicted to methadone maintenance treatment
Have at least a diploma
Married
Exclusion criteria:
Single
illiterate
Substance dependent individuals treated with other treatments than methadone
People with psychotic and paranoid disorders
High score in psychological coherence questionnaire
High score in couple intimacy questionnaire
A high score in the problem-oriented stress coping strategies questionnaire
Age
From 18 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
The sample consisted of 60 opiate addicts treated with methadone in 3 months of summer 1401 with inclusion criteria and available sampling of 60 people and in the form of simple random allocation so that the samples are numbered and entered in Excel software from 1 to 60, respectively. And then with the data analysis plugin sampling tools the numbers are accidentally messed up and From row 1 to 20, an intervention group from row 21 to 40 will be placed in an intervention group and from row 41 to 60 of 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
Research ethics committee of Islamic Azad University, Kerman branch
Street address
No. 37, Alley 45, North Obzar Street
City
Kerman
Province
Kerman
Postal code
7617773793
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.IAU.KERMAN.REC.1400.030
Health conditions studied
1
Description of health condition studied
opioid addicts under methadone maintenance treatment
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
People's scores in Endler's stress coping strategies questionnaire
Timepoint
Measuring stress coping strategies at the beginning of the study and after 12 weeks at the end of the intervention
Method of measurement
Endler's stress coping strategies questionnaire
2
Description
People's scores in the Flensberg Coherence Questionnaire
Timepoint
Measuring the sense of psychological coherence at the beginning of the study and after 12 weeks at the end of the intervention
Method of measurement
Flensberg sense of coherence questionnaire
3
Description
People's scores in the Walker and Thomson Marital Intimacy Questionnaire
Timepoint
Measuring the feeling of marital intimacy at the beginning of the study and after 12 weeks at the end of the intervention
Method of measurement
Walker and Thomson Marital Intimacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: cognitive behavioral therapy, by teaching the techniques and principles of this therapy in 12 sessions, we help patients to understand the thoughts and feelings that affect their behavior.
Category
Treatment - Other
2
Description
The second intervention group: therapy based on commitment and acceptance, which consists of 4 approaches: awareness, acceptance, commitment, and behavior change, and in 12 sessions, by teaching related principles and techniques, we try to create people's psychological flexibility in such a way that they need It is not to remove or eliminate the bad feeling, but despite the existence of this feeling, the person should move towards value-based behavior
Category
Treatment - Other
3
Description
Control group: no training to the subjects, who during these 12 sessions that are taught to the two intervention groups, this group does not receive any training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pars Drug Abuse Treatment Center
Full name of responsible person
Mojtaba Ebrahim Nejad
Street address
Firuzeh Crossroads
City
Kerman
Province
Kerman
Postal code
7617783494
Phone
+98 913 987 1955
Email
ap.sbuk@gmail.com
2
Recruitment center
Name of recruitment center
Mahta Substance Abuse Treatment Center
Full name of responsible person
Mojtaba Ebrahim Nejad
Street address
Mofateh St. has not reached the Daneshjo Intersection
City
Kerman
Province
Kerman
Postal code
7617783494
Phone
+98 913 987 1955
Email
ap.sbuk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Hamid Molaei
Street address
Kerman Branch, Islamic Azad University, Waliasr Blvd.
City
Kerman
Province
Kerman
Postal code
7635168111
Phone
+98 34 3321 0043
Email
Saleh.g1992@gmail.com
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
Saleh Ghiasi Nejad
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 37, Alley 45, North Obzar Street
City
Kerman
Province
Kerman
Postal code
7617773793
Phone
+98 34 3251 4448
Email
Saleh.g1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Alireza Manzari Tavakoli
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman Branch, Islamic Azad University, Waliasr Blvd.
City
Kerman
Province
Kerman
Postal code
7635168111
Phone
+98 34 3321 0043
Email
a.manzari@iauk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saleh Ghiasi Nejad
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 37, Alley 45, North Obzar Street
City
Kerman
Province
Kerman
Postal code
7617773793
Phone
+98 34 3251 4448
Email
Saleh.g1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
The raw data file extracted from the questionnaires
Statistical data analysis file
When the data will become available and for how long
The access period starts 8 months after the results are published
To whom data/document is available
Only for researchers and employees in academic institutions
Under which criteria data/document could be used
In order to use these data during communication, necessary arrangements are made regarding the permitted analysis.
They can only be used for academic research
From where data/document is obtainable
They can make necessary arrangements to receive data by sending emails and communicating.
ُSaleh.g1992@gmail.com
09132479877
What processes are involved for a request to access data/document
After the request is made by the applicant and confirmation is received from the supervisor, the data file is sent via email