Comparative study of the effectiveness of Unified transdiagnostic group therapy (UP) and cognitive-behavioral group therapy (CBT) on reducing comorbid sleep problems, emotional disturbances, drug cravings and relapse prevention in Men with opioid use disorder living in Therapeutic Community (TC)
Comparison of the effectiveness of integrated transdiagnostic group therapy (UP) with cognitive-behavioral group therapy (CBT) on reducing sleep problems associated with drug dependence disorder in male patients treated in Therapeutic Community (TC)
Comparison of the effectiveness of integrated transdiagnostic group therapy (UP) with cognitive-behavioral group therapy (CBT) on reducing emotional distress associated with drug dependence disorder in male patients treated in Therapeutic Community (TC)
Comparison of the effectiveness of integrated transdiagnostic group therapy (UP) with cognitive-behavioral group therapy (CBT) on reducing craving in men with substance use disorder treated in Therapeutic Community (TC)
Comparison of the effectiveness of integrated transdiagnostic group therapy (UP) with cognitive-behavioral group therapy (CBT) in preventing relapse in men with substance use disorder treated in Therapeutic Community (TC)
Design
tow arm parallel group (with control group) randomized trial
Settings and conduct
Using a convenient sampling method and based on entry and exit criteria, 45 people were selected .in Arshia Alborz TC .protocol training
Participants/Inclusion and exclusion criteria
No psychiatric disorder or specific medical disorders (such as head trauma, seizures, etc.)
Age between 18 and 65 years
Literacy at least up to the first year of high school
Recording the amount and type of sleeping medication used
Being under treatment for at least three months
Willingness to participate in the study
Starting treatment within the last month
Assessment of substance use history and type or types of substance used
Intervention groups
Three groups of 15 people, including the UP group, the CBT group, and the usual treatment group in the centers
Main outcome variables
Reducing sleep problems, emotional disturbance, substance cravings, and preventing relapse
General information
Reason for update
Acronym
GCBT-GUP
IRCT registration information
IRCT registration number:IRCT20251027067788N1
Registration date:2026-02-13, 1404/11/24
Registration timing:retrospective
Last update:2026-02-13, 1404/11/24
Update count:0
Registration date
2026-02-13, 1404/11/24
Registrant information
Name
Tabassom Saeid par var
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 4766
Email address
tabassom.spr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2026-01-05, 1404/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of Unified transdiagnostic group therapy (UP) and cognitive-behavioral group therapy (CBT) on reducing comorbid sleep problems, emotional disturbances, drug cravings and relapse prevention in Men with opioid use disorder living in Therapeutic Community (TC)
Public title
The effectiveness of group therapy on opioid users undergoing treatment in Therapeutic Community
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Men with features of opioid use disorder in a Therapeutic Community
Do not have a psychiatric disorder
Have no history of specific medical disorders (such as head trauma, seizures, etc.)
Literacy at least up to the first year of high school
Recording the amount and type of sleeping medication used and being under treatment for at least three months in addiction treatment centers
Willingness to participate in the study (informed consent)
Treatment started within the last month
Assessing substance use history and type(s) of substance used
Exclusion criteria:
Simultaneous use of multiple addictive substances
Comorbidity with severe psychiatric disorders such as bipolar disorder, psychotic disorders, and other disorders that may overshadow the therapeutic relationship
No motivation for treatment
Mental retardation/disability
Having a history of previous psychological interventions, especially CBT
Diagnosis of a comorbid condition such as schizophrenia or bipolar disorder, or other conditions specifically other than impulsivity and sleep problems
Changing the dosage of sleep medications
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:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Individual. Random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ایران
Street address
No.131 Setani Ave . first square of Tehran pars /Tehran. Iran. t
City
Tehran
Province
Tehran
Postal code
1651699614
Approval date
2025-07-15, 1404/04/24
Ethics committee reference number
IR.IUMS.REC.1404.424
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F11.2
ICD-10 code description
Opioid dependence, in remission
Primary outcomes
1
Description
Comorbid sleep problems are the scores that subjects obtain on the Morin Insomnia Severity Index (ISI) (1993). Emotional disturbance is the score that the subject receives on the Depression, Anxiety, Stress Scale (DASS, Lavibond & Lavibond, cited in Anthony et al., 1998). Craving is the score that participants obtain on the Drug Craving Questionnaire (DDQ) developed by Franken et al. (2002). Relapse prevention is actually the result that the subject obtains on the Morphine Trial (TLC), such that a positive result indicates relapse and re-use, and a negative result indicates relapse prevention.
Timepoint
The beginning of the study, the end of the study (about two months), and the two-month follow-up after treatment.
Method of measurement
Drug Craving Questionnaire (DDQ). Morphine Test (TLC). Morin Insomnia Severity Index (ISI). Depression, Anxiety, Stress Scale (DASS). Unified Transdiagnostic Group Therapy (UP). Cognitive Behavioral Group Therapy (CBT). Psychiatric Symptom Checklist - Short Form (SCL-25). Structured Clinical Interview (SCID).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Unified transdiagnostic group therapy. This type of therapy identifies and targets factors that are common to multiple mental disorders. The 12-session protocol of Barlow et al. (2020; 2011) will be used. This protocol consists of 12 60-minute sessions.
Category
Behavior
2
Description
Intervention group 2: Cognitive-Behavioral Therapy (CBT) is a psychotherapy approach that uses a combination of cognitive and behavioral therapy methods in a group setting. The goal of this approach is to help individuals identify and change unhealthy thought and behavioral patterns and develop coping skills. This program consists of 12 sessions, each session lasting 60 minutes.
Category
Behavior
3
Description
Control group: Control group: Control group with normal and conventional treatments at the TC center.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arshia (Therapeutic Community )Comprehensive Addiction Treatment Center
Full name of responsible person
Dr. Ali Rafeeie
Street address
End of Laleh Street 17 - South of Sultan Abad Ring Road Malek Abad. Karaj
City
Alborz. Karaj
Province
Alborz
Postal code
-
Phone
+98 912 147 0441
Email
markazjamearshia@gmail.com
Web page address
https://www.instagram.com/markazjamearshia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabassom Saeid par var
Full name of responsible person
-
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8670 2030
Email
intl@iums.ac.ir
Web page address
https://en.iums.ac.ir/
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
tabassom saeid par var
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8670 2030
Email
intl@iums.ac.ir
Web page address
https://en.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Position
Vice President for Research and Technology, Iran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
safa.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tabassom saeid par var
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 131 setany alley First square Tehran pars
City
Tehran
Province
Tehran
Postal code
1651699614
Phone
+98 21 7770 8904
Email
tabassom.spr@gmail.com
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