Amphetamine AddictionNCT04531384
Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.
A study testing robot-assisted rehabilitation intelligent treatment and standard psychotherapy treatment in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Amphetamine Addiction
- What is being tested?
- robot-assisted rehabilitation intelligent treatment and standard psychotherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
- Education level equal or more than 9 years;
- Have normal or corrected-to-normal vision;
- Have normal or corrected-to-normal hearing;
- Less than 3 months before last drug use;
Who cannot join
- Current substance use (except nicotine or caffeine);
- History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
- Intelligence quotient less than 70.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Gaojing Rehabilitation Center
Shanghai, 200030
Jianyan Dai
About this study
Official title: Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders
The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.
Read the detailed description
Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.
- Conditions
- Amphetamine Addiction
- Being tested
- robot-assisted rehabilitation intelligent treatment, standard psychotherapy treatment
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted rehabilitation intelligent treatmentDevice
robot-assisted rehabilitation psychotherapy
standard psychotherapy treatmentOther
standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted rehabilitation intelligent treatment | Experimental | Participants assigned to this condition were offered 10 weekly individual sessions of robot-assisted rehabilitation treatment, delivered by the Robot-assisted rehabilitation intelligent system. The system contains 10 core cognitive-behavioral therapy (CBT) skill topics (such as functional analysis, coping skills training, reviewing practice exercises, explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants. Receives: Device: robot-assisted rehabilitation intelligent treatment |
| treatment as usual | Other | Participants in the treatment-as-usual group were offered standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions, which consisted of weekly group and/or individual therapy, as determined by the clinical team. Receives: Other: standard psychotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of galvanic skin response during the virtual reality based addiction assessment system
The galvanic skin response is an emotional physiological indicator, and its unit is ohm.
Measured: in 1 year
Secondary outcomes (7)
Treatment motivation
Using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) to measure the treatment motivation of the participants. The score of the scale is between 19 and 95. The higher the score, the higher the treatment motivation.
Measured: in 1 year
Anxiety
Anxiety is assessed by the State-Trait Anxiety Scale (SAS). The score of the SAS scale is between 0 and 80. The higher the score, the more severe the anxiety symptoms.
Measured: in 1 year
Depression
Depression is assessed by the the Beck Depression Scale (SDS). The score of the SDS scale is between 0 and 80. The higher the score, the more severe the depression symptoms.
Measured: in 1 year
Attentional bias related to drugs and emotional stimulation
The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.
Measured: in 1 year
Risky decision-making
Balloon Analogue Risk Task is used for assess the risky decision-making ability. The indicator is the average number of balloon blows, and its unit is times.
Measured: in 1 year
Reaction inhibition ability
Stop signal task is used for assess the reaction inhibition ability. The indicator is the reaction time when the participant completes the task, and its unit is milliseconds.
Measured: in 1 year
Changes of electroencephalogram power spectrum during the virtual reality based addiction
The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV^2.
Measured: in 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Dec 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine AddictionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531384
- Sponsor's protocol ID
- MZhao-010
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2020
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT04531384
- Acronym / sponsor ID
- MZhao-010
- Conditions
- Amphetamine Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.
Detailed description
Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted rehabilitation intelligent treatment | Experimental | Device: robot-assisted rehabilitation intelligent treatmentParticipants assigned to this condition were offered 10 weekly individual sessions of robot-assisted rehabilitation treatment, delivered by the Robot-assisted rehabilitation intelligent system. The system contains 10 core cognitive-behavioral therapy (CBT) skill topics (such as functional analysis, coping skills training, reviewing practice exercises, explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants. |
| treatment as usual | Other | Other: standard psychotherapy treatmentParticipants in the treatment-as-usual group were offered standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions, which consisted of weekly group and/or individual therapy, as determined by the clinical team. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
- Education level equal or more than 9 years;
- Have normal or corrected-to-normal vision;
- Have normal or corrected-to-normal hearing;
- Less than 3 months before last drug use;
Key exclusion criteria (3 listed)
- Current substance use (except nicotine or caffeine);
- History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
- Intelligence quotient less than 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot-assisted rehabilitation intelligent treatmentrobot-assisted rehabilitation psychotherapy | Device | robot-assisted rehabilitation intelligent treatment |
| standard psychotherapy treatmentstandard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions | Other | treatment as usual |
Primary outcome
Changes of galvanic skin response during the virtual reality based addiction assessment system
Time frame: in 1 year
The galvanic skin response is an emotional physiological indicator, and its unit is ohm.
7 secondary outcomes
Treatment motivation
Time frame: in 1 year
Anxiety
Time frame: in 1 year
Depression
Time frame: in 1 year
Attentional bias related to drugs and emotional stimulation
Time frame: in 1 year
Risky decision-making
Time frame: in 1 year
Reaction inhibition ability
Time frame: in 1 year
Changes of electroencephalogram power spectrum during the virtual reality based addiction
Time frame: in 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhao principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted rehabilitation intelligent treatment and standard psychotherapy treatment in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zhao (64387250, drminzhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of galvanic skin response during the virtual reality based addiction assessment system (time frame: in 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.