Protocol summary

Study aim
Determining the effectiveness of acceptance and commitment therapy on reducing cravings and increasing psychological resilience in people with substance abuse
Design
The clinical trial has an experimental and control group, with parallel groups, no blinding, randomized, and is conducted on 50 people. A random number table is used for randomization.
Settings and conduct
The study is conducted on people with substance abuse in Ahvaz. 50 people with substance abuse are selected using a convenient and purposeful sampling method and according to the inclusion criteria. They are randomly divided into two intervention groups and a control group. The intervention is carried out in 8 90-minute sessions, one session per week for 2 months. Also, blinding is not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: diagnosis of substance abuse or substance use disorder based on DSM-5-TR or diagnosis by a psychiatrist/psychologist, being between 20 and 50 years old, having at least 6 months of regular substance use history, and exclusion criteria included: having an acute psychiatric disorder or requiring hospitalization prior to the study, having a severe or debilitating physical illness, and taking psychiatric medications.
Intervention groups
The intervention group includes people with substance abuse who receive 8 90-minute sessions, one session per week, under the intervention protocol of internal family system training. While the control group does not receive any intervention.
Main outcome variables
Craving, psychological flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260902070889N1
Registration date: 2026-09-06, 1405/06/15
Registration timing: prospective

Last update: 2026-09-06, 1405/06/15
Update count: 0
Registration date
2026-09-06, 1405/06/15
Registrant information
Name
Ali Delfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5919 8022
Email address
akbarsg1393@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on reducing cravings and increasing psychological resilience in people with substance abuse.
Public title
The effectiveness of acceptance and commitment therapy on reducing cravings and increasing psychological flexibility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of substance abuse or substance use disorder based on DSM-5-TR or diagnosis by a psychiatrist/psychologist Being between 20 and 50 years old At least 6 months of regular substance use history
Exclusion criteria:
Having an acute psychiatric disorder or requiring hospitalization prior to the study Having a severe or debilitating physical illness Taking psychiatric medications
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of eligible subjects to the intervention and control groups will be simple random, using a random sequence generated by a random number table on the Randomization.com website. (To prepare a randomization list on the Randomization.com website, first enter the number of samples, the number of groups, and the type of randomization (such as block); then the website automatically generates a random list for assigning subjects to the research groups, which can be used in the sampling or subject assignment process.) This sequence is written in lowercase letters and kept in a sealed envelope. When each individual is selected, the envelope is opened and the individual is assigned to the counseling or control group according to the code.
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, Ahvaz Branch
Street address
Southern Kargar Boulevard, Culture City, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-05-26, 1405/03/05
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.139

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
Substance abuse
Timepoint
At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention.
Method of measurement
Drug Use Propensity Questionnaire by Franken et al. (2002)

2

Description
Psychological flexibility
Timepoint
At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention.
Method of measurement
Personalized Psychological Flexibility Questionnaire by Kashden et al. (2020)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Session 1: Introduction and Creative HopelessnessIntroducing the group members, therapist, and objectives of the treatment sessionsExplaining the rules and framework of the sessionsAssessing the participants’ history of attempts to control craving, using questions such as: “What have you tried? What was the outcome?”Conducting the “Control Is the Problem” exerciseDiscussing the costs of experiential avoidance and attempts to control unpleasant internal experiencesSession 2: Acceptance and Contact with the Present MomentExplaining the concept of acceptance of internal experiencesTeaching and practicing mindful breathingConducting the “Sitting with Craving” exercise, with the aim of observing craving without acting upon itUsing the “Passengers on the Bus” metaphor to address thoughts related to substance useSession 3: Cognitive DefusionExplaining the concepts of cognitive fusion and cognitive defusionTeaching and practicing defusion exercises, including repeating thoughts in a cartoon voiceWriting thoughts on leaves and allowing them to drift awayPracticing “Labeling Thoughts” using the statement: “This is just a thought”Helping participants develop psychological distance from thoughts and beliefs associated with substance useSession 4: Self-as-ContextIntroducing the concept of self-as-contextUsing the “Sky and Weather” metaphor to illustrate the distinction between the observing self and thoughts and emotionsConducting the observer-self exercise and observing thoughts as clouds passing through the skyExplaining the distinction between the “conceptualized self” and the “observing self”Using the “Chessboard and Chess Pieces” metaphor to facilitate a better understanding of this conceptSession 5: ValuesClarifying participants’ fundamental life valuesIdentifying values that participants wish to pursue in a life free from substance use, such as family, work, and healthConducting the “Funeral/Eulogy” or “80th Birthday” exercise to identify and prioritize important life valuesExploring the distinction between values and goalsExamining the role of values in developing motivation for behavioral changeSession 6: Committed ActionEstablishing small, value-based goals using the SMART frameworkDeveloping plans for engaging in value-consistent actions despite the presence of craving and substance-related thoughtsConducting the “Small Steps” exerciseIdentifying potential barriers to behavioral changeStrengthening participants’ commitment to engaging in behaviors consistent with their personal valuesSession 7: Integrating ACT Processes and Craving ManagementReviewing the six core ACT processesConducting the comprehensive exercise of “Accepting Craving, Cognitive Defusion, and Value-Based Action”Role-playing and practicing responses to high-risk situations associated with substance useTeaching strategies for responding to lapsesReviewing participants’ experiences and strengthening their recommitment to the process of changePracticing the simultaneous use of acceptance, mindfulness, cognitive defusion, and values in real-life situationsSession 8: Review, Consolidation, and Follow-UpReviewing participants’ progress throughout the treatment sessionsReviewing and reinforcing the skills learned during treatmentReviewing and completing the final homework assignmentsDeveloping a relapse-prevention planAdministering the post-test assessmentSummarizing the overall treatment processConcluding the treatment and planning follow-up
Category
Treatment - Other

2

Description
Control group: They do not receive any training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pasargad Addiction Treatment Clinic
Full name of responsible person
Babak Hashemi
Street address
No. 112, between Soltani and Mansouri, Salman Farsi St
City
Ahvaz
Province
Khouzestan
Postal code
6171584922
Phone
+98 61 3551 2893
Email
pasargad.atc@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farid Jamali Shini
Street address
South Kargar Blvd, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Fax
+98 61 3332 9200
Email
info@iauahvaz.ac.ir
Web page address
https://ahvaz.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Full name of responsible person
Ali Delfi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 9, Shahid Salman Pour Street, Bandaghir
City
Shoshtar
Province
Khouzestan
Postal code
6147528963
Phone
+98 61 5919 8022
Fax
Email
ali_delfi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delfi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 9, Shahid Salman Pour Street, Bandaghir
City
Shoshtar
Province
Khouzestan
Postal code
6147528963
Phone
+98 61 5919 8022
Fax
Email
ali_delfi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delfi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 9, Shahid Salman Pour Street, Bandaghir
City
Shoshtar
Province
Khouzestan
Postal code
6147528963
Phone
+98 61 5919 8022
Fax
Email
ali_delfi@gmail.com

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
Study data, treatment protocol
When the data will become available and for how long
After publishing the articles
To whom data/document is available
All those interested in research in this field
Under which criteria data/document could be used
Any type of analysis on the submitted data is permitted and acceptable with attribution of the source.
From where data/document is obtainable
Via email to Ali Delfi at: ali_delfi@gmail.com
What processes are involved for a request to access data/document
Send an email to Ali Delfi and after approval by the research team members, the data will be sent.
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