The Effectiveness of Mindfulness-based Relapse Prevention

NCT ID: NCT06739304

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-11-10

Brief Summary

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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

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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.

Conditions

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Substance Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based Relapse Prevention

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based Relapse Prevention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

57 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanhui Liao, MD

Role: STUDY_DIRECTOR

Sir Run Run Shaw Hospital

Locations

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Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Other Identifiers

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U22A20302

Identifier Type: -

Identifier Source: org_study_id

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