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The Effect of Neuroscience-Informed Psychoeducation (NIPE) on Self-Efficacy of People with Substance Use Disorder

Protocol summary

Study aim
Examining the effect of neuroscience-informed psychoeducation (NIPE) on self-efficacy of people with substance use disorder
Design
Two arms parallel group randomized trial with three months follow-up
Settings and conduct
The study sample will be taken from outpatient treatment centers. Eligible participants will be divided into intervention or control groups and the intervention group will receive four 120-minute training sessions.
Participants/Inclusion and exclusion criteria
• Ages 18 to 65 years • Male • Detection of substance use disorders (opiates, methamphetamine, cannabis or alcohol) based on DSM-5 criteria • Receiving standard treatment based on Ministry of Health protocols (more than two weeks and less than 24 weeks after treatment) • Failure to understand intervention protocol or assessments • Referral to legal centers • Psychiatric disorders that are severe (such as severe depression, bipolar disorder, psychosis and suicide history)
Intervention groups
Neuroscience-informed psychoeducation (NIPE)Protocol (NIPE): Includes ten main areas (including: attention, memory, decision making and control, mobility and speech, brain-body communication, arousal and sleep, pleasant feeling, unpleasant feeling, social cognition and awareness and Insight), will be performed in four 120-minute sessions in intervention group. The control group receive only standard treatment and after one month of pre-test, which is equivalent to four weekly sessions of the experimental group, they are re-evaluated. The ten areas are taught in four sessions in the following order: • Session One: Attention and Memory • Second session: unpleasant sensation, brain-body communication, arousal and sleep • Third session: decision making and control, mobility and speech • Fourth session: awareness, insights, social skills, pleasant feeling
Main outcome variables
Self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121020011172N3
Registration date: 2020-04-26, 1399/02/07
Registration timing: registered_while_recruiting

Last update: 2020-04-26, 1399/02/07
Update count: 0
Registration date
2020-04-26, 1399/02/07
Registrant information
Name
Hamed Ekhtiari
Name of organization / entity
The center of molecular and cellular imaging
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 3626
Email address
h_ekhtiari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Neuroscience-Informed Psychoeducation (NIPE) on Self-Efficacy of People with Substance Use Disorder
Public title
The Effect of Neuroscience-Informed Psychoeducation in People with Addiction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65 years Male Detection of substance use disorders (opiates, methamphetamine and cannabis or alcohol) based on DSM-5 Receiving standard treatment based on Ministry of Health protocols (more than two weeks and less than 24 weeks after treatment) Desire and informed consent to enter the project
Exclusion criteria:
• Failure to understand intervention protocol or assessments• Concurrent participation in research projects providing pharmacological or psychological interventions • Referral to legal centers • Psychiatric disorders that are severe (such as severe depression, bipolar disorder, psychosis and suicide history )
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: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be a randomized block design with 6 blocks, the sequence of randomization will be determined through sealedenvelope.com site and based on this, the researcher considers eligible subjects for two study groups.
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 Tehran University of Medical Sciences
Street address
Ghods Ave, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.TUMS.VCR.REC.1398.771

Health conditions studied

1

Description of health condition studied
Substance Use Disorder
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

2

Description of health condition studied
Alcohol Use Disorder
ICD-10 code
F10
ICD-10 code description
Alcohol related disorders

Primary outcomes

1

Description
Self-efficacy measured by Situational Confidence Questionnaire (SCQ)
Timepoint
Before and after the intervention
Method of measurement
Self-efficacy measured by Situational Confidence Questionnaire (SCQ)

Secondary outcomes

1

Description
Cognitive problems in response to self-reported cognitive difficulties questionnaire
Timepoint
Before and after the intervention
Method of measurement
Cognitive problems in response to self-reported cognitive difficulties questionnaire

2

Description
The mood status in response to the Positive and Negative Affect Schedule (PANAS)
Timepoint
Before and after the intervention
Method of measurement
The mood status in response to the Positive and Negative Affect Schedule (PANAS)

3

Description
Passion and satisfaction: Subjective response measured on a visual analogue scale
Timepoint
Before and after the intervention
Method of measurement
Passion and satisfaction: Subjective response measured on a visual analogue scale

4

Description
Life satisfaction in response to The Satisfaction With Life Scale (SWLS)
Timepoint
Before and after the intervention
Method of measurement
Life satisfaction in response to The Satisfaction With Life Scale (SWLS)

Intervention groups

1

Description
Intervention group: Neuroscience-informed psychoeducation (NIPE)Protocol (NIPE): Includes ten main areas (including: attention, memory, decision making and control, mobility and speech, brain-body communication, arousal and sleep, pleasant feeling, unpleasant feeling, social cognition and awareness and Insight), will be performed in four 120-minute sessions in intervention group. T.The ten areas are taught in four sessions in the following order:• Session One: Attention and Memory• Second session: unpleasant sensation, brain-body communication, arousal and sleep• Third session: decision making and control, mobility and speech• Fourth session: awareness, insights, social skills, pleasant feeling
Category
Other

2

Description
Control group: The control group receive only standard treatment and after one month of pre-test, which is equivalent to four weekly sessions of the experimental group, they are re-evaluated.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Nastaran Malmir
Street address
Iranian National Center for Addiction Studies (INCAS), Farabi Hospital, Qazvin Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1635713366
Phone
+98 21 5542 1155
Email
incas@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Ekhtiari
Street address
Tehran University of Medical Sciences, Central department, the crossing of Qods Street and Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Nastaran Malmir
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iranian National Center for Addiction Studies (INCAS), Farabi Hospital, Qazvin Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1635713366
Phone
+98 21 5542 1155
Fax
Email
nastaranmalmir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laureate Institute for Brain Research
Full name of responsible person
Dr Hamed Ekhtiari
Position
Associate Investigator-Laureate Institute for Brain Research
Latest degree
Specialist
Other areas of specialty/work
Neuroimaging
Street address
Laureate Institute for Brain Research 6655 South Yale Avenue
City
Tulsa
Province
Tulsa
Postal code
74136-3326
Phone
001 918 502 5100
Fax
Email
hekhtiari@laureateinstitute.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Nastaran Malmir
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iranian National Center for Addiction Studies (INCAS), Farabi Hospital, Qazvin Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1635713366
Phone
+98 21 5542 1155
Fax
Email
nastaranmalmir@yahoo.com
Web page address

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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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