The Effectiveness of Mindfulness-based Relapse Prevention

March 26, 2025 updated by: Sir Run Run Shaw Hospital

The Effectiveness of Mindfulness-based Relapse Prevention: A Randomized Controlled Trial Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Relapse Prevention
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
250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-Depression Scale (PHQ-9)
Time Frame: 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.
before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Beck Anxiety Inventory (BAI-21)
Time Frame: 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.
before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
region segmental task
Time Frame: before and immediately after the mindfulness-based intervention
correct rate of reginal segmental task
before and immediately after the mindfulness-based intervention
fMRI
Time Frame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Brain structure and brain function
before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Investigators

  • Study Director: Yanhui Liao, MD, Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Actual)

August 5, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U22A20302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and privacy consideration, IPD might not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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