Protocol summary

Study aim
To determine the effectiveness of Emotion Efficacy Therapy on emotional memory, emotion regulation strategies, rumination, and relapse tendency in individuals with substance use disorder undergoing methadone maintenance treatment.
Design
Randomized controlled trial, parallel-group, single-blind (assessor-blinded), with a control group and 1:1 allocation ratio. The sample size is estimated at 30 participants (15 per group). Simple randomization will be used. Data analysis will be performed based on intention-to-treat (ITT) using multivariate analysis of covariance (MANCOVA)
Settings and conduct
the study will be conducted in methadone maintenance treatment clinics in Ahvaz, Iran. two time points (pre-test and post-test) by an assessor psychologist who is blinded to group allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to read, write, and attend sessions; providing informed consent; absence of severe mental illnesses (schizophrenia spectrum, bipolar I, severe personality disorders) based on DSM-5 clinical interview; meeting DSM-5 diagnostic criteria for substance use disorder; age 25–45 years; not receiving any concurrent psychological treatment; being treated with methadone for at least the past 3 months.Exclusion criteria: Developing severe psychological disorders during intervention; more than 2 absences from sessions; unwillingness to continue treatment; relapse of substance use (positive morphine test).
Intervention groups
Intervention group: Emotion Efficacy Therapy (EET) delivered in 8 weekly 90-minute sessions (based on McKay & West, 2016 protocol).Control group: Structured psychoeducation (8 sessions of 90 minutes including general education on relapse prevention, stress management, and craving coping) for ethical considerations
Main outcome variables
Emotional memory (EMT); emotion regulation strategies (ERQ); rumination relapse tendency (RPS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260530069576N1
Registration date: 2026-06-01, 1405/03/11
Registration timing: retrospective

Last update: 2026-06-01, 1405/03/11
Update count: 0
Registration date
2026-06-01, 1405/03/11
Registrant information
Name
Nassim Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 390 8569
Email address
nassim.rre@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-04-30, 1405/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effectiveness of Emotion Efficacy Therapy on Emotional Memory, Emotion Regulation Strategies, Rumination, and Relapse Tendency in Individuals with Substance Use Disorder Under Methadone Maintenance Treatment
Public title
Examining the Effectiveness of Emotion Efficacy Therapy on Emotional Memory, Emotion Regulation Strategies, Rumination, and Relapse Tendency in Individuals with Substance Use Disorder Under Methadone Maintenance Treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read, write, and attend sessions Having informed consent to participate in the research and completing the informed consent form Not having severe mental illnesses including schizophrenia spectrum disorders, bipolar type I, and severe personality disorders (assessed via clinical interview) Meeting diagnostic criteria for substance use disorder Being aged 25 to 45 years Not receiving any psychological treatment Being treated with methadone
Exclusion criteria:
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 30
15 people in the intervention group and 15 people in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple (lottery). The names of all eligible and volunteer participants are written on identical separate pieces of paper. A person external to the research, who has no role in patient enrollment or assessment, randomly draws the names from a container
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a single-blind (assessor-blind) method is used. Participants and the therapist cannot be blinded to the type of intervention due to the nature of group psychotherapy and skills training, which makes it impossible to conceal the treatment type from these two groups. However, the assessor responsible for data collection (a clinical psychologist) is completely blinded to group allocation (intervention or control). The assessor has no role in the treatment process and is unaware of the type of intervention received by each participant prior to conducting the post-test. Additionally, the statistical data analyst is also blinded to group allocation, as data are provided using numeric codes without any mention of group names. Thus, bias in outcome measurement and data analysis is minimized.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشکده پزشکی دانشگاه علوم پزشکی کرمانشاه
Street address
Taq-e Bostan Boulevard, Kermanshah University of Medical Sciences, Faculty of Medicine, Second Floor, Ethics Committee
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2026-02-01, 1404/11/12
Ethics committee reference number
IR.KUMS.MED.REC.1404.268

Health conditions studied

1

Description of health condition studied
Substance Use Disorder
ICD-10 code
F19.2
ICD-10 code description
Other psychoactive substance dependence

Primary outcomes

1

Description
Emotional Memory
Timepoint
Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions)
Method of measurement
Emotional Memory Task

2

Description
Emotion Regulation Strategies
Timepoint
Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions)
Method of measurement
Emotion Regulation Questionnaire

3

Description
Rumination
Timepoint
Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions)
Method of measurement
Ruminative Responses Scale

4

Description
Relapse Tendency
Timepoint
Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions)
Method of measurement
Relapse Prediction Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

2

Description
Control group:
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital
Full name of responsible person
Nassim Rezaei
Street address
Sepidar
City
Ahvaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 21 1111 1111
Email
nassim.rre@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
KUM
Street address
Kermanshah - Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
daftarriasat@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Nassim Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sepidar
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۷۷۷۷۴۶۹۰
Phone
+98 21 0000 0000
Email
Re.nasim@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nassim Rezaei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sepidar-mehrgan4
City
Ahvaz
Province
Khouzestan
Postal code
6177111111
Phone
00980000000000
Email
nassim.rre@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nassim Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sepidar
City
Ahvaz
Province
Khouzestan
Postal code
6111111111
Phone
00980000000000
Email
nassim.rre@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
داده‌های فردی شرکت‌کنندگان به صورت غیرقابل شناسایی (بدون نام و با کد عددی) شامل: نمرات پیش‌آزمون و پس‌آزمون متغیرهای حافظه هیجانی (آزمون حافظه هیجانی)، راهبردهای تنظیم هیجان (پرسشنامه ERQ)، نشخوار فکری (مقیاس RRS) و گرایش به عود (پرسشنامه RPS) به همراه اطلاعات دموگرافیک (سن، جنسیت، وضعیت تأهل، تحصیلات، مدت مصرف، مدت درمان با متادون). فایل راهنمای متغیرها و پروتکل مطالعه نیز ارائه خواهد شد. عنوان و جزیی
When the data will become available and for how long
Starting six months after publication of the main results (after manuscript acceptance and print) and continuing for 5 years.
To whom data/document is available
Researchers affiliated with recognized academic or research institutions (universities, research centers, teaching hospitals). Requests from industry (private companies) will be considered on a case-by-case basis if the proposed use aligns with research ethics.
Under which criteria data/document could be used
Data may be used solely for legitimate and ethical research purposes such as meta-analysis, independent replication, verification of results, or secondary analyses related to substance use disorder, emotion regulation, and emotion efficacy therapies. Commercial use or any attempt to re-identify participants is prohibited. Requests must include a scientific proposal and approval from the requester's institutional ethics committee.
From where data/document is obtainable
Nassim Rezaei (corresponding researcher / MSc student) via email: Nassim.rre@gmail.com Alternatively, the principal investigator, Dr. Nasrin Jaberghaderi, can be contacted at: n_jg2004@yahoo.com Postal address: Department of Clinical Psychology, Faculty of Medicine, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard, Kermanshah, Iran.
What processes are involved for a request to access data/document
Requester sends a written request including a scientific proposal, approval from their institutional ethics committee, and a clear description of the intended use to the above emails. The request will be reviewed by the principal investigator and researcher within 2 weeks. If approved, the requester must sign a data use agreement (committing to no re-identification and no commercial use). After receiving the signed agreement, a download link for the de-identified data (Excel or CSV format) along with a data dictionary will be provided within 1 week. The entire process typically takes less than 1 month.
Comments
Loading...