The effect of emotion regulation-based educational program on the level of general health, adaptive and self-regulating emotion of patients with opioid abuse under methadone maintenance therapy
Determining the effect of education program based on emotion regulation on the level of general health, adaptation and self-regulation of emotion in patients with opioid abuse under methadone maintenance
Design
A clinical trial with a control group, with parallel, randomized groups, on 48 patients with opioid abuse who were randomly divided into two groups of experimental and control.
Settings and conduct
the samples from the Article 16 Injury Reduction Center of Isfahan will be selected by available sampling method and again by random sampling method using block classification will be assigned to two groups. The intervention group will participate in 6 training sessions based on emotion regulation during 3 weeks.
Participants/Inclusion and exclusion criteria
Entry requirements:
Be able to read and write.
Based on his report, he should have a suitable general situation to complete the questionnaire.
Have more than six months of continuous opioid abuse (diagnosis of substance use disorder at the time of intervention
No entry conditions:
Having severe physical and mental illnesses
Participate in another similar study simultaneously
Intervention groups
Intervention group: In 6 sessions, emotion regulation training participates in a group and the interventions include 6 sessions of emotion regulation training based on the Gross model, which was held as a group (two sessions per week). The duration of each session is 90 minutes. All participants in the pre-test and post-test stages of the Goldberg General Health Questionnaire will complete the Garnefski Emotion Self-Regulation and Rabio Adaptation.
Comparison group: During this period, they will receive the prescribed routine treatments. They only complete the mentioned questionnaires in the pre-test and post-test stages.
Main outcome variables
general health, adaptation and self-regulation of emotion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N2
Registration date:2022-05-21, 1401/02/31
Registration timing:prospective
Last update:2022-05-21, 1401/02/31
Update count:0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotion regulation-based educational program on the level of general health, adaptive and self-regulating emotion of patients with opioid abuse under methadone maintenance therapy
Public title
The effect of emotion regulation-based educational program on the level of general health, adaptive and self-regulating emotion of patients with opioid abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be between 18 and 65 years old
Be able to read and write.
Based on his report, he should have a suitable general situation to complete the questionnaire.
Have more than six months of continuous opioid abuse (diagnosis of substance use disorder at the time of intervention
Be interested and satisfied to participate in this research.
Exclusion criteria:
Having severe physical and mental illnesses
Participate in another similar study simultaneously
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a block with size 4. Randomization unit: individual. Random allocation software. Random chain concealment is by placing patient codes in opaque envelopes.
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 Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.035
Health conditions studied
1
Description of health condition studied
addiction
ICD-10 code
R78.4
ICD-10 code description
Finding of other drugs of addictive potential in blood
Primary outcomes
1
Description
general health
Timepoint
Immediately before the intervention and 21 days after the intervention
Method of measurement
Goldberg General Health Scale
2
Description
Emotional Adjustment
Timepoint
Immediately before the intervention and 21 days after the start of the intervention
Method of measurement
Emotional Adjustment Measure (EAM)
3
Description
Emotional self-regulation
Timepoint
Immediately before the intervention and 21 days after the intervention
Intervention group: The intervention group will participate in 6 sessions of emotion regulation training in a group manner and the control group will receive the prescribed routine treatments during this period. The interventions include 6 sessions of emotion regulation training based on the Gross model, which were held in groups (two sessions per week). The duration of each session is 90 minutes.
Category
N/A
2
Description
Control group: During the research, the control group will receive only the medical treatments provided by the center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Harm Reduction Center Article 16 of the city of Isfahan
Full name of responsible person
Amir Musarezaie
Street address
Baharstarn, Qaleh Shor Road, Article 16 Damage Reduction Center
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available