Clinical trial NCT06739304: The Effectiveness of Mindfulness-based Relapse Prevention
Official title: The Effectiveness of Mindfulness-based Relapse Prevention: A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Keywords: addiction
Mindfulness-based Relapse Prevention
anxiety
depression
subliminal perception
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire-Depression Scale (PHQ-9)
timeFrame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
measure: Beck Anxiety Inventory (BAI-21)
timeFrame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
measure: region segmental task
timeFrame: before and immediately after the mindfulness-based intervention
measure: fMRI
timeFrame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yanhui Liao, MD
role: STUDY_DIRECTOR
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