The Effectiveness of Mindfulness-based Relapse Prevention

NCT06739304 | Completed

• 1 other identifier: U22A20302
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorder

Keywords

addiction; Mindfulness-based Relapse Prevention; anxiety; depression; subliminal perception

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire-Depression Scale (PHQ-9)

  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.

  before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention

• Beck Anxiety Inventory (BAI-21)

  Anxiety Assessment with 21 items. Minimum score is 0, and maximum is 63. The higher scores indicate higher levels of anxiety.

  before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention

• region segmental task

  correct rate of reginal segmental task

  before and immediately after the mindfulness-based intervention

• fMRI

  Brain structure and brain function

  before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention

Study Arms (2)

Mindfulness-Based Relapse Prevention

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Relapse Prevention

Control group

NO INTERVENTION

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.

Interventions

Mindfulness-based Relapse Prevention BEHAVIORAL

250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists.

Mindfulness-Based Relapse Prevention

Eligibility Criteria

• Age: 25 Years - 57 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (30)

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MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Behavioral Symptoms

Study Officials

• Yanhui Liao, MD

  Sir Run Run Shaw Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2024
• Study Start: June 10, 2023
• Primary Completion: August 5, 2023
• Study Completion: November 10, 2023
• Last Updated: April 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)