The Effectiveness of Mindfulness-based Relapse Prevention

Zhejiang University

Status: Completed

Conditions: Substance Use Disorder

Treatments: Behavioral: Mindfulness-based Relapse Prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT06739304

U22A20302

Details and patient eligibility

About

This study developed a Mindfulness-based Relapse Prevention targeting craving. Based on the Randomized Controlled Trial design, 600 adult USD females and 600 adult USD males with methamphetamine, heroin, or ketamine in Intervention group(MBI) , the matched 250 subjects in Control group and 250 healthy matched controls (HC) participated in this study, 1200 adult USD subjects of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists. SUD patients were assessed three times, before, during(1-2 weeks after the MBI began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fMRI and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness.

Full description

The Group Mindfulness-based intervention adhered to structured formal procedures, conducted by psychiatrists, and was scheduled once a week, where each session spans for two hours, interspersed with a 10-minute break. Starting from the second intervention, the previous intervention's contents and home practice were reviewed at the beginning of each subsequent intervention.

Based on the Randomized Controlled Trial design, the evaluation time nodes for clinical variables, cognitive task(reginal segmental task),fMRI and blood test were baseline (before intervention), 1-2 weeks after intervention began, and after intervention. All clinical variable scales were presented in paper form, the questions were clearly explained by researchers.

Enrollment: 1,200 patients

Sex: Female

Ages: 25 to 57 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Meets the diagnostic criteria for DSM-5 of substance use disorders;
2. The duration of using the addictive substance shall not be less than 1 year;
3. Prohibit addictive substances for at least 48 hours before conducting magnetic resonance imaging scans;
4. Han nationality, junior high school or above education level, aged 18-57 years old;
5. Informed and agreed to participate in this study, with the consent of the Ethics Committee.

Exclusion criteria

1. Have a history of mental illness before taking drugs;
2. Other substance use disorders (excluding nicotine);
3. Brain organic diseases, history of craniocerebral injury, history of coma;
4. Individuals with mental disorders who meet the DSM-5 diagnostic criteria within two generations;
5. History of endocrine diseases; Those with abnormal function in blood, heart, liver, and kidney after examination;
6. Intelligence impairment IQ.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Mindfulness-Based Relapse Prevention

Experimental group

Description:

250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists，and were assessed three times, before, during(1-2 weeks after the MBI began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fMRI and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness.

Treatment:

Behavioral: Mindfulness-based Relapse Prevention

Control group

No Intervention group

Description:

the matched 250 females in Control group were assessed by the by a variety of clinical variables, cognitive task(reginal segmental task),FMRI and blood test.