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IRCT20251027067788N1 IRCT 2026-02-13 Tabassom Saeid par var The effectiveness of group therapy on opioid users undergoing treatment in Therapeutic Community GCBT-GUP 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) 2025-12-06 anticipated 45 Complete https://irct.ir/trial/87296 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: no, Randomization description: Simple randomization. Individual. Random number table. N/A Addiction. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Control group: Control group with normal and conventional treatments at the TC center. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision will be made based on the order of the Vice Chancellor of the University.
public tabassom saeid par var
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) 1416634793 +98 21 8670 2030 intl@iums.ac.ir Iran University of Medical Sciences scientific Majid Safa
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 2503 safa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Male 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 F11.2 Opioid dependence, in remission Behavior Behavior Treatment - Other 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. 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. Control group: Control group: Control group with normal and conventional treatments at the TC center. 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). - Approved 2025-07-15 کمیته اخلاق دانشگاه علوم پزشکی ایران No.131 Setani Ave . first square of Tehran pars /Tehran. Iran. t Tehran Tehran Iran (Islamic Republic of)