Protocol summary

Study aim
Determining the effectiveness of acceptance and commitment therapy on resilience, alexithymia, and fear of relapse to addiction in people with substance use disorders in addiction treatment centers in Ahvaz.
Design
A controlled, double-blind, randomized, parallel-group clinical trial on 30 patients. Random Number Generator software will be used for randomization.
Settings and conduct
This study is a field experimental research with a pretest–posttest control group design. The statistical population consisted of all substance abusers in the city of Ahvaz in 2024 who had referred to addiction treatment centers and had been diagnosed with addiction. Among them, 30 individuals were selected through simple random sampling and assigned to two groups: an experimental group (15 individuals) and a control group (15 individuals). The experimental group received Acceptance and Commitment Therapy (ACT) based on the Hayes and Wilson (2004) model over eight 90-minute sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being between the ages of 18-50 Having had an addiction for at least one year Having a history of admission to addiction treatment centers Exclusion Criteria: Having a specific physical or psychological illness that affects the treatment process Taking psychiatric medications Undergoing education and other addiction-related treatments
Intervention groups
Intervention group: A set of therapeutic interventions based on increasing commitment and psychological flexibility, including increasing the individual's psychological connection with their thoughts and feelings, which will be held in 8 sessions, each session lasting 90 minutes, based on the Hayes and Wilson (2004) therapeutic model, for the experimental group. Control group: Will not receive any intervention.
Main outcome variables
Resilience; alexithymia; fear of relapse into addiction.

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20250916067273N1
Registration date: 2025-09-23, 1404/07/01
Registration timing: prospective

Last update: 2025-09-23, 1404/07/01
Update count: 0
Registration date
2025-09-23, 1404/07/01
Registrant information
Name
Mohsen Khatibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 418 8388
Email address
mohsen.khatibi.13@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-07, 1404/07/15
Expected recruitment end date
2025-10-17, 1404/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on resilience, alexithymia, and fear of relapse to addiction in people with substance use disorder.
Public title
The effectiveness of acceptance and commitment therapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between the ages of 18-50 Having had an addiction for at least one year Having a history of being admitted to addiction treatment centers
Exclusion criteria:
Having a specific physical or psychological illness that affects the treatment process Taking psychiatric medications Undergoing education and other addiction-related treatments
Age
From 18 years old to 50 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, to achieve completely random assignment and eliminate any researcher interference or bias, a simple randomization method will be used. First, a complete list of individuals with a history of substance use disorder in addiction treatment centers who meet the study inclusion criteria will be prepared. Then, each of these individuals will be assigned an initial numerical identification code. These codes will be entered into the Random Number Generator software. The software will generate a unique random number for each individual. After the numbers are generated, the participants will be listed in ascending order based on the value of the random number. Then, sequentially, the first to fifteenth people on the list will be assigned to the experimental group and the sixteenth to thirtieth people will be assigned to the control group. This process will be designed in such a way that the order of entry or the researcher's knowledge of the participants will have no role in the assignment, and it will not be possible to predict the group of each individual before randomization is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz
Street address
Islamic Azad University of Ahvaz, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.255

Health conditions studied

1

Description of health condition studied
Drug use disorder
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

Description
Resilience
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Connor and Davidson Resilience Scale (2003)

2

Description
Aphasia
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Toronto and Taylor Alexithymia Scale (1986)

3

Description
Return to addiction
Timepoint
Substance Abuse Relapse Questionnaire (2007)
Method of measurement
before performing the intervention and two weeks after completion of the intervention

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A set of therapeutic interventions based on increasing commitment and psychological flexibility, including increasing the individual's psychological connection with their thoughts and feelings, will be held in 8 sessions, each session lasting 90 minutes, based on the Hayes and Wilson (2004) therapeutic model.
Category
Behavior

2

Description
Control group: They receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Aftab Addiction Counseling and Treatment Clinic
Full name of responsible person
Mohsen Khatibi
Street address
No. 4, 3rd Floor, Mizan Building, Behind Javad Al-A’emmeh Mosque, Shahid Farjavani St., Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6183993199
Phone
+98 937 418 8388
Email
Mohsen.khatibi.13@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pezhman Tghipour Birgani
Street address
Islamic Azad University of Ahvaz, Farhang Shahr.
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Parvin Ehteshamzadeh
Proportion provided by this source
100
Public or private sector
Private
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
Mohsen Khatibi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, 3rd Floor, No. 22, Farshid 1 St., Melli Rah Alley
City
Ahvaz
Province
Khouzestan
Postal code
6163767448
Phone
+98 937 418 8388
Email
Mohsen.khatibi.13@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Khatibi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, 3rd Floor, No. 22, Farshid 1 St., Melli Rah Alley
City
Ahvaz
Province
Khouzestan
Postal code
6163767448
Phone
+98 937 418 8388
Email
Mohsen.khatibi.13@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Khatibi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, 3rd Floor, No. 22, Farshid 1 St., Melli Rah Alley
City
Ahvaz
Province
Khouzestan
Postal code
6163767448
Phone
+98 937 418 8388
Email
Mohsen.khatibi.13@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is completely confidential and I do not intend to publish it.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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