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The effect of family-centered neuropsychological training interventions on reducing stress, marital incompatibility, drug craving and cognitive-emotional regulation of married drug-dependent clients

Protocol summary

Study aim
The aim of the current research is to show what therapeutic methods exist to reduce stress, marital incompatibilities, drug addiction and cognitive-emotional regulation, and that family-oriented neuropsychological training interventions reduce stress, marital incompatibility, drug addiction. Drugs and cognitive-emotional regulation of married clients dependent on drugs are effective.
Design
Clinical trial with control group, with factorial groups, single-blind, randomized, on 30 patients. A table of random numbers was used for randomization.
Settings and conduct
The study site was a hospital, patients admitted to the neuropsychiatric department, obtaining informed consent and placing them in two experimental and control groups. One-sided blinding that they are unaware of how to receive or not receive the treatment package of the other group.
Participants/Inclusion and exclusion criteria
1- having the diagnostic criteria of substance dependence based on DSM-5, 2-The person suffering from addiction must be at least 18 years old and at most 40 years old; 3-The level of education of the person suffering from addiction should be at least elementary; 4-The person is not taking antipsychotic drugs (such as haloperidol) and does not have bipolar or dissociative disorder.
Intervention groups
Experimental group: receiving the combined techniques of training sessions Control group: They will receive the usual treatment and will not participate in the researcher's training sessions.
Main outcome variables
Neuropsychological, family-oriented, stress, marital incompatibilities, drug addiction, cognitive-emotional regulation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231204060264N1
Registration date: 2023-12-11, 1402/09/20
Registration timing: prospective

Last update: 2023-12-11, 1402/09/20
Update count: 0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Hanieh Goli Rostami
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 0044
Email address
hani_ebi80@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered neuropsychological training interventions on reducing stress, marital incompatibility, drug craving and cognitive-emotional regulation of married drug-dependent clients
Public title
The effect of family-centered neuropsychological training interventions on reducing stress, marital incompatibility, drug craving and cognitive-emotional regulation of married drug-dependent clients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the diagnostic criteria of substance dependence based on DSM-5 The person suffering from addiction must be at least 18 years old and at most 40 years old The education level of the person suffering from addiction should be at least elementary The person is not taking antipsychotic drugs (such as haloperidol) and does not have bipolar or dissociative disorder
Exclusion criteria:
Taking psychiatric drugs Not cooperating with the therapist Not doing the main tasks
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling method was used. Randomization method: simple randomization Randomization unit: cluster Randomization tool: table of random numbers In the first step, using available sampling, first the hospital was selected, then in the next step, married drug-dependent patients admitted to the neuropsychiatric department of the hospital were selected, and after the necessary explanations about the objectives of the research and the stages of the research, and obtaining consent With the knowledge of the participants, they were randomly assigned to the experimental and control groups using a table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were blinded. They will know that they have participated in a study, but they will not know how to receive or not receive the treatment package of the other group.
Placebo
Not used
Assignment
Factorial
Other design features
Designing a treatment protocol and package that is a combination of four treatments.

Secondary Ids

1

Registry name
000
Secondary trial Id
0
Registration date
2023-12-07, 1402/09/16

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University
Street address
Shahid Chamran Highway - Jalal Al Ahmad St. - opposite Koi Nasr, Dr. Kardan St
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۹۸۳۸۶۱
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
IR.UT.PSYEDU.REC.1402.037

Health conditions studied

1

Description of health condition studied
Addicted to drugs
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Primary outcomes

1

Description
Stress: means the sum of scores that the respondents will get from answering questions 1 to 14 of Everly and Girdano's (1980) questionnaire.
Timepoint
The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention.
Method of measurement
Standard stress questionnaire

2

Description
Marital incompatibility: refers to the sum of scores that respondents will get from answering questions 1 to 32 of Spanier's (1976) questionnaire.
Timepoint
The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention.
Method of measurement
Marital incompatibility standard questionnaire

3

Description
Craving for drug use: it means the sum of scores that respondents will get from answering questions 1 to 14 of Franken, Hendricks, and VandenBernick (2002) questionnaire.
Timepoint
The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention.
Method of measurement
Standard substance craving questionnaire

4

Description
Cognitive regulation of emotion: it means the sum of the scores that the respondents will get from answering questions 1 to 36 of the Granfsky, Kraij and Spinhoven (2001) questionnaire.
Timepoint
The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention.
Method of measurement
Standard questionnaire of cognitive emotion regulation

Secondary outcomes

1

Description
Stress: means the sum of scores that the respondents will get from answering questions 1 to 14 of Everly and Girdano's (1980) questionnaire.
Timepoint
After the completion of the intervention and 90 days after the completion of the intervention.
Method of measurement
Standard stress questionnaire

2

Description
Marital incompatibility: refers to the sum of scores that respondents will get from answering questions 1 to 32 of Spanier's (1976) questionnaire.
Timepoint
After the completion of the intervention and 90 days after the completion of the intervention.
Method of measurement
Marital incompatibility standard questionnaire

3

Description
Craving for drug use: it means the sum of scores that respondents will get from answering questions 1 to 14 of Franken, Hendricks, and VandenBernick (2002) questionnaire.
Timepoint
After the completion of the intervention and 90 days after the completion of the intervention.
Method of measurement
Standard substance craving questionnaire

4

Description
Cognitive regulation of emotion: it means the sum of the scores that the respondents will get from answering questions 1 to 36 of the Granfsky, Kraij and Spinhoven (2001) questionnaire.
Timepoint
After the completion of the intervention and 90 days after the completion of the intervention.
Method of measurement
Standard questionnaire of cognitive emotion regulation

Intervention groups

1

Description
Intervention group: Family-centered neuropsychological therapy training for ten sessions
Category
Treatment - Other

2

Description
Control group: They will undergo the usual medical care and will not participate in the researcher's training sessions.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar educational research and treatment center
Full name of responsible person
Dr Mohammad Kermani
Street address
Golestan town, Amin Blvd., Kosar Medical Research Training Center
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 0000
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Kermani
Street address
Golestan town, Amin Blvd., Kosar Medical Research Training Center
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 0000
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan 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
University of Tehran
Full name of responsible person
Hanieh Goli Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Imam Reza Blvd., Taleghani 1st, Shahid Ramzanpur Alley, Ghasemian House
City
Sari
Province
Mazandaran
Postal code
4818953653
Phone
+98 11 3327 0044
Email
hani_ebi80@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Hanieh Goli Rostami
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4818953653, Shaid Ramzanpour Ave, Taleghani Aval st, Emam Reza Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4818953653
Phone
+98 11 3327 0044
Fax
Email
Hani_ebi80@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Hanieh Goli Rostami
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4818953653, Shaid Ramzanpour Ave, Taleghani Aval st, Emam Reza Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4818953653
Phone
+98 11 3327 0044
Fax
Email
Hani_ebi80@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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