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IRCT20210525051403N1 IRCT 2021-06-06 Self funded Mindfulness Based Relapse Prevention Therapy in Individuals with Amphetamine Use Disorder MBRP RCT 21 Mindfulness Based Relapse Prevention Therapy in Individuals with Amphetamine Use Disorder 2021-06-10 anticipated 90 Complete https://irct.ir/trial/56482 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Following initial instruction with recruited groups, subjects were randomly allocated using randomization to one of the two groups. An online "Clinical trial randomizer" (www.randomization.com) (Suresh, 2011) was conducted the treatment selection randomly. Participants were assigned to either MBRP + TAU or TAU, with repeated assessments at baseline. Parallel assignments were given to both groups. These procedures were conducted in a group setting. 2-3 Amphetamine-type stimulants. Intervention 1: Intervention group: This group contains individuals with amphetamine use disorder. Following consenting procedures and randomization, all participants in the experimental group underwent an initial baseline assessment. We had an assessment at four different time points at baseline, mid-treatment, post-treatment and end of follow-up. The intervention comprises eight weekly two-hour group therapy sessions delivered by two facilitators with 10-12 people. Each session focused on a novel concept, such as understanding personal triggers, immediate attention, and allowing/letting go, skillfully reacting to emotional and physical interactions, intrusive thought comprehension, or compassion in action. This group will also receive usual treatments like pharmacotherapy and 12 steps program as control group participants are receiving. Intervention 2: Control group: This group contains individuals with amphetamine use disorder. Following consenting procedures and randomization, all participants in the control group underwent an initial baseline assessment. We had an assessment at four different time points at baseline, mid-treatment, post-treatment and end of follow-up. In this group, individuals were received continued in their ongoing treatment and management plan provided by the rehab centre to support his sobriety through a 12- step, process-focused model.This group will receive usual treatments like pharmacotherapy and 12 steps program. Yes - There is a plan to make this available What will be shared: After the study is completed, the participant's data will be provided without identifying information. Clinical study report: After the study is completed, the clinical study report will be available. When: From Jan 2022, To whom: Researchers of mental health studies Conditions: For systematic reviews and meta-analysis, studies are permitted. Where to obtain: Safe care trust international main motorway Chowk near Almazan college; Email sctrwp@gmail.com How to obtain: The data request needs to clearly define data needs. The study contact person will provide data within a 2week after receiving the request. Comments:
public Aftab Hussain
Safe Care Trust International, main motorway chowk near almizan college, Islamabad
Islamabad Pakistan 44000 092629250235 aftab_hussain12@yahoo.com Islamia University Bahawalpur scientific aftab Hussain
Safe Care Trust International, main motorway chowk near almizan college, Islamabad
Islamabad Pakistan 44000 +92 51 5494233 aftab_hussain12@yahoo.com Islamia University Bahawalpur Pakistan Pakistan Age between 18 and 40 years age and therefore legally eligible to consent. A history of use of methamphetamine and a diagnosis of stimulant use disorder as described in the Mental Disorders Diagnostic and Statistical Manual (DSM-5); the passage of more than a week from complete methamphetamine detoxification and negative urine test. Be able to speak and read Urdu, sign a written consent for the participants to take part in the study, be mindful. Apart from signing into a written agreement, they have their rights, including the protection of personal data, the immunity to physical or mental harm, and the possibility of quitting the study they wish. All participants would go through urinalysis to make sure that they are not intoxicated 18 years 40 years Male Unwilling to attend the meetings, absenteeism of more than two sessions, engage concurrently in other health services, and have a long-term dependency on multi-drug concurrently; Requisite medical detoxification from any substances Those are suffering from severe medical and neuropsychiatric complications or any psychotic illness at the time of screening for intake Participants those are unavailable or hesitant to be a part of the study for the 20 weeks An individual having a history of using illicit substance use (e.g. cocaine, heroin) Already completed MBRP sessions. 304.40 (F1 AMPHETAMINE-TYPE SUBSTANCE USE DISORDER Behavior Behavior Intervention group: This group contains individuals with amphetamine use disorder. Following consenting procedures and randomization, all participants in the experimental group underwent an initial baseline assessment. We had an assessment at four different time points at baseline, mid-treatment, post-treatment and end of follow-up. The intervention comprises eight weekly two-hour group therapy sessions delivered by two facilitators with 10-12 people. Each session focused on a novel concept, such as understanding personal triggers, immediate attention, and allowing/letting go, skillfully reacting to emotional and physical interactions, intrusive thought comprehension, or compassion in action. This group will also receive usual treatments like pharmacotherapy and 12 steps program as control group participants are receiving. Control group: This group contains individuals with amphetamine use disorder. Following consenting procedures and randomization, all participants in the control group underwent an initial baseline assessment. We had an assessment at four different time points at baseline, mid-treatment, post-treatment and end of follow-up. In this group, individuals were received continued in their ongoing treatment and management plan provided by the rehab centre to support his sobriety through a 12- step, process-focused model.This group will receive usual treatments like pharmacotherapy and 12 steps program. To measure impulsivity in ATS users. Timepoint: Baseline; During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: Barratt Impulsiveness Scale-11. Craving in ATS users. Timepoint: Baseline; During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: Penn Alcohol Craving Scale (PACS) adopted for methamphetamine. Aggression in ATS users. Timepoint: Baseline;During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT);3-month follow-up. Method of measurement: Aggression Questionnaire (Buss & Perry, 1992). Self efficacy in ATS users. Timepoint: Baseline; During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: General Self-Efficacy Scale (GSES). Coping skills in ATS users. Timepoint: Baseline; During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: Brief COPE inventory (Carver, 1997). Quality of life in ATS users. Timepoint: Baseline; During Intervention the beginning of week 5 Post-intervention, the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: WHOQOl-BREF (WHO, 1998). Measuring risk of relapse in ATS users. Timepoint: Baseline; the end of the week (PRIMARY ENDPOINT); a 3-month follow-up. Method of measurement: Stimulant Relapse Risk Scale (SRRS). Self funded by researcher Approved 2021-02-26 Department of Psychology Ethics Committee (DPEC)The Islamia University Bahawalpur Baghdad ul jadeed campus, Hasilpur road, Bahawalpur, Pakistan Bahawalpur Punjab Pakistan