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Completed

NCT Number: NCT06739304

The Effectiveness of Mindfulness-based Relapse Prevention

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.

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Key information

Conditions

Substance Use Disorder Anxiety Disorders Behavior Behavior, Addictive Behavioral Symptoms Chemically-Induced Disorders Compulsive Behavior Depression Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

25 year–57 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mindfulness-based relapse prevention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. region segmental task

    Time frame: before and immediately after the mindfulness-based intervention

    correct rate of reginal segmental task

  4. fMRI

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

    Brain structure and brain function

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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