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The Effectiveness of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment

Protocol summary

Study aim
Determining the Effectiveness of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment
Design
A randomized, controlled, parallel-group clinical trial will be conducted on 30 individuals undergoing substance abuse treatment. Participants will be randomly assigned to either the intervention group or the control group using a simple randomization method.
Settings and conduct
This study is being conducted at the Sina Substance Abuse Treatment Center in Semnan, involving individuals undergoing treatment for substance abuse who, following an initial assessment, are randomly assigned to either an intervention group or a control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18–60 years, diagnosis of substance use disorder, at least one month of maintenance treatment, and informed consent. Exclusion criteria: severe psychiatric or cognitive disorders, need for hospitalization or urgent psychiatric services, and concurrent use of substances or medications affecting cognitive and emotional states.
Intervention groups
In this study, the intervention group undergoes an integrated transdiagnostic intervention delivered in eight weekly, 90-minute sessions. The session content encompasses increasing awareness of emotional experiences, identifying maladaptive emotional and behavioral patterns, teaching emotion regulation skills, fostering acceptance of and exposure to emotions, and reducing experiential avoidance. The control group does not receive the specialized intervention and continues to receive their usual therapeutic services throughout the study.
Main outcome variables
Experiential avoidance, emotion regulation, and treatment durability.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260920071126N1
Registration date: 2026-09-24, 1405/07/02
Registration timing: prospective

Last update: 2026-09-24, 1405/07/02
Update count: 0
Registration date
2026-09-24, 1405/07/02
Registrant information
Name
Fatemeh Shahjouei
Name of organization / entity
Islamic Azad University, Semnan Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3342 1655
Email address
fateme.shahjuiee@iau.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-22, 1405/07/30
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment
Public title
The Effect of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Visiting and receiving treatment services at substance abuse treatment centers in the city of Semnan. Ages 18 to 60 Diagnosis of substance use disorder based on medical records At least one month of history receiving maintenance therapy Stability of physical and mental condition at the time of enrollment in the study Informed consent and willingness to participate in research Ability to comprehend material and complete research instruments Possessing the readiness and ability to attend intervention sessions regularly
Exclusion criteria:
Suffering from severe psychiatric disorders such as psychosis or severe bipolar disorder Presence of cognitive impairment or intellectual disability affecting the understanding and implementation of the intervention Urgent need for hospitalization or specialized psychiatric services Concomitant use of substances or medications that significantly affect an individual's cognitive and emotional state.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible individuals will be randomly assigned to either the intervention or control group following initial assessments. A simple randomization method will be employed for this purpose. First, each participant will be assigned a unique identification number. These numbers will then be entered into the Random Allocation Software (RAS) to randomly assign participants to the intervention or control group. To maintain the independence of the allocation process and minimize the risk of bias, randomization will be performed by an individual independent of the intervention implementation team. This approach ensures that every participant has an equal chance of being assigned to either 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
Ethics Committee of Islamic Azad University, Semnan Branch
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2026-08-31, 1405/06/09
Ethics committee reference number
IR.IAU.SEMNAN.REC.1405.075

Health conditions studied

1

Description of health condition studied
Opioid abuse
ICD-10 code
F11.1
ICD-10 code description
Opioid abuse

Primary outcomes

1

Description
Experiential avoidance
Timepoint
Before the start of the intervention and after the completion of the 8 intervention sessions
Method of measurement
Gámez et al.'s (2014) Brief Experiential Avoidance Questionnaire

2

Description
Emotion regulation
Timepoint
Before the start of the intervention and after the completion of the 8 intervention sessions
Method of measurement
Gross and John (2003) Emotion Regulation Questionnaire

3

Description
Treatment retention
Timepoint
From the start of maintenance treatment until treatment discontinuation by the participant
Method of measurement
The number of days of treatment retention, from initiation to discontinuation.

Secondary outcomes

1

Description
Substance craving
Timepoint
Before the start of the intervention and after the completion of the 8 intervention sessions
Method of measurement
Somoza et al.'s (1995) Substance Craving Questionnaire

2

Description
Substance cessation self-efficacy
Timepoint
Before the start of the intervention and after the completion of the 8 intervention sessions
Method of measurement
Bramson's Addiction Cessation Self-Efficacy Questionnaire (1999)

3

Description
Quality of life
Timepoint
Before the start of the intervention and after the completion of the 8 intervention sessions
Method of measurement
World Health Organization Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: The intervention group undergoes an integrated transdiagnostic intervention consisting of eight weekly, 90-minute sessions. This intervention is designed to reduce experiential avoidance, improve emotion regulation, and enhance treatment durability. The sessions focus on increasing individuals' awareness of their emotional experiences, thoughts, and behavioral patterns, as well as identifying maladaptive emotion regulation strategies. Subsequently, using transdiagnostic techniques, participants are taught skills related to acceptance and emotional exposure, the reduction of experiential avoidance, emotion regulation, and the modification of maladaptive patterns. In the final sessions, the acquired skills are reviewed, with an emphasis on consolidating and applying them in daily life and situations relevant to the treatment process.
Category
Treatment - Other

2

Description
Control group: Participants in this group will not receive any intervention from the researcher during the study and will simply benefit from the center's standard treatment services. No additional therapeutic or educational sessions will be conducted for this group, and their routine treatment process will continue unchanged.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Substance Abuse Treatment Center
Full name of responsible person
Majid Mazinani
Street address
No. 59, 11th East St., Modarres Blvd., Motahari Square
City
Semnan
Province
Semnan
Postal code
3519751128
Phone
+98 23 3344 7553
Email
Mazinani.majid@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Nader Rahbar
Street address
No. 1, Central Building, Islamic Azad University, Semnan Branch, University Campus, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 6180
Email
nrahbar@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, Semnan Branch
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, Semnan Branch
Full name of responsible person
Fatemeh Shahjouei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 911, 20th East St., Damavand Square, Raziyeh Town
City
Semnan
Province
Semnan
Postal code
3519955563
Phone
+98 23 3342 1655
Email
fateme.shahjuiee@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Shahab Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 4, Faculty of Humanities, Islamic Azad University, University Campus, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
Shahab.moradi@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Fatemeh Shahjouei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 911, 20th East St., Damavand Square, Rouziyeh Town
City
Semnan
Province
Semnan
Postal code
3519955563
Phone
+98 23 3342 1655
Email
fateme.shahjuiee@iau.ir

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
Yes - There is 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
All data will be available for sharing after the removal of participants’ identifying information and confirmation that the data are fully anonymized.
When the data will become available and for how long
The data can be made available one week after the results are published.
To whom data/document is available
The data and documentation from this study will be accessible exclusively to researchers and specialists in fields related to substance abuse, psychology, behavioral sciences, and the treatment of substance use disorders who are affiliated with academic institutions, research centers, and reputable scientific organizations.
Under which criteria data/document could be used
The data and documentation may be used for study or research purposes, provided the source is cited.
From where data/document is obtainable
If the data is required, please contact fateme.shahjuiee@iau.ir via email.
What processes are involved for a request to access data/document
Upon receipt and review of the request by the principal investigator, the data—accompanied by an undertaking not to publish the data without the principal investigator's name—will be sent to the requester within a maximum of one week.
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