The Effectiveness of Mindfulness-based Relapse Prevention

Not Applicable

Completed

• Conditions: Substance Use Disorder

• Registration Number: NCT06739304
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-06-10
• Primary Completion: 2023-08-05
• Study Completion: 2023-11-10
• Study First Submitted: 2023-11-30
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-Depression Scale (PHQ-9)	before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention	A quick depression assessment. The minimum score is 0 and maximum is 27. Higher scores indicate higher levels of depression. Minimal depression: scores 1-4. Mild depression: scores 5-9. Moderate depression: scores 10-14. Moderately severe depression: 15-19. Severe depression: 20-27.
Beck Anxiety Inventory (BAI-21)	before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention	Anxiety Assessment with 21 items. Minimum score is 0, and maximum is 63. The higher scores indicate higher levels of anxiety.
region segmental task	before and immediately after the mindfulness-based intervention	correct rate of reginal segmental task
fMRI	before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention	Brain structure and brain function

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China