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IRCT20170702034844N5 IRCT 2020-04-28 Iranian National Center for Addiction Studies effectiveness of mindfulness-based relapse prevention group therapy among people with opioids use disorder comparing the effectiveness of mindfulness-based relapse prevention group therapy with treatment as usual on shame, perfectionism and self-criticism among people with opioids use disorder 2019-07-23 anticipated 30 Complete https://irct.ir/trial/40080 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: randomization: using a random sequence generation, a quadrilateral block is used with a random number table. allocation: by a third-party supervisor who is a physician at the National Center fo Addictive Studies and coordinating the placement of each patient in each treatment group. N/A Opioids dependence. Intervention 1: Intervention group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.Then they reieve the mindfulness based relapse prevention intervention whithin 8 sessions. This programe is combined of mindfulness skills and cognitive behavioral therapy. This group will also recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies. At the end of the intervention and 1 month after that, questionarres will be reapeted. Intervention 2: Control group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.This group will recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies.At the end of the intervention of intervention group and after 1 month later, control group will fill the questionarres again. Yes - There is a plan to make this available What will be shared: Participants data file: The participants data without identifying information will be available after copmletion of the study. Clinical study report: The clinical study report will be available after completion of the study. When: From August 2020 To whom: Researchers of psychiatric disorders clinical studies. Conditions: Using study data for systematic reviews and meta-analysis studies is permitted. Where to obtain: Dr. Alireza Noroozi,Psychiatric clinic, Iranian National Center for Addiction Studies, No 486, south karegar St, Tehran, Iran. Email: a_r_noroozi@yahoo.com How to obtain: The data request need to clearly define data needs. The study contact person will provide available data within 1 week after receiving the request. Comments:
public Dr. Alireza Noroozi
No 486, South kargar St, Qazvin Sq, Next to Farabi Hospital
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1155 a_r_noroozi@yahoo.com Tehran University of Medical Sciences scientific Dr. Alireza Noroozi
No 486, South karegar St, Qazvin Sq, Next to Farabi Hospital
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1155 a_r_noroozi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) age: 20 to 45 years old education: at least 8 grades opioids use disorder based on DSM-5 criteria informed consent for participating in research maitenance therapy with methadone or buprenorphine more than 1 week and less than 24 weeks 20 years 45 years Both having psychotic syptoms organic brain disorder having suicide thoughts based on interiew meeting critera for personality disorder F11.2 Opioid dependence Behavior Behavior Intervention group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.Then they reieve the mindfulness based relapse prevention intervention whithin 8 sessions. This programe is combined of mindfulness skills and cognitive behavioral therapy. This group will also recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies. At the end of the intervention and 1 month after that, questionarres will be reapeted. Control group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.This group will recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies.At the end of the intervention of intervention group and after 1 month later, control group will fill the questionarres again. Shame score other ad shamer scale. Timepoint: Before starting the treatment, after treatment, and 1 month after treatment. Method of measurement: Using other as shamer scale. Scores in positive and negative perfectionism questionarre. Timepoint: Before starting the treatment, after treatment, and 1 month after treatment. Method of measurement: Using positive and negative perfectionism questionarre. Scores in self-criticism questionarre. Timepoint: Before starting the treatment, after treatment, and 1 month after treatment. Method of measurement: Using self criticism questionarre. Iranian National Center for Addiction Studies Approved 2019-07-20 Ethics commitee of shahid beheshti university faculty of cognitive sciences and brain, shahid beheshti university, daneshjoo blvd, Evin. Tehran Tehran Iran (Islamic Republic of)