Alcohol Use DisorderNCT05675553
The Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With AUD
A study testing robot-assisted rehabilitation intelligent treatment and treatment as usual in people with Alcohol Use Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- robot-assisted rehabilitation intelligent treatment and treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 31 Mar 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-55;
- Meeting DSM-5 criteria for alcohol use disorders;
- Withdrawing alcohol for less than 12 months;
- Ability to use computers;
- Signing informed consent;
Who cannot join
- Having comorbidities of other neuropsychiatric diseases;
- Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- With a family history of mental illness
- Not familiar with computer operation, unable to complete assessment and treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 23000
Min Zhao, MD, 34289888-3193, drminzhao@smhc.org.cn
Shuo Li, MA, +8613905536086, ls520522@sjtu.edu.cn
About this study
Official title: A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders
We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater efficacy than traditional therapy in the treatment of alcohol use disorders.
Read the detailed description
Based on artificial intelligence technology, face recognition technology, and 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 patients with alcohol use disorders, and compare with traditional treatment to verify the efficacy and safety of the Robot-assisted rehabilitation intelligent system in Chinese patients with alcohol use disorders.
- Conditions
- Alcohol Use Disorder
- Being tested
- robot-assisted rehabilitation intelligent treatment, treatment as usual
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted rehabilitation intelligent treatmentDevice
Participants assigned to this condition were offered 10 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, and explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants. The treatment framework is semi-structured through human-computer interaction. The forms of interaction include inquiries, statements, recommendations summaries, and knowledge assessments.
treatment as usualOther
Both groups will receive treatment as usual, including medication, exercise, and psychological education.
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted rehabilitation intelligent treatment | Experimental | Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system. Receives: Device: robot-assisted rehabilitation intelligent treatment; Other: treatment as usual |
| treatment as usual | Other | Participants in the treatment-as-usual group were offered standard treatment at the mental health hospitals, which consisted of group and/or individual therapy, as determined by the clinical team. Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desire for alcohol
The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).
Measured: 3 months
Secondary outcomes (8)
Change Readiness and Treatment Eagerness
The secondary outcome includes participants' Change Readiness and Treatment Eagerness, measured by the Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES).
Measured: 3 months
Impulsiveness
The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).
Measured: 3 months
Anxiety
The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).
Measured: 3 months
Depression
The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).
Measured: 3 months
Perception of stress
The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).
Measured: 3 months
Sleep Quality
The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).
Measured: 3 months
coping style
The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).
Measured: 3 months
use of alcohol
The secondary outcome includes participants' use of alcohol.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675553
- Sponsor's protocol ID
- MZhao-011
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT05675553
- Acronym / sponsor ID
- MZhao-011
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Jan 2023 (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.
We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater efficacy than traditional therapy in the treatment of alcohol use disorders.
Detailed description
Based on artificial intelligence technology, face recognition technology, and 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 patients with alcohol use disorders, and compare with traditional treatment to verify the efficacy and safety of the Robot-assisted rehabilitation intelligent system in Chinese patients with alcohol use disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted rehabilitation intelligent treatment | Experimental | Device: robot-assisted rehabilitation intelligent treatment, Other: treatment as usualBoth groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system. |
| treatment as usual | Other | Other: treatment as usualParticipants in the treatment-as-usual group were offered standard treatment at the mental health hospitals, which consisted of group and/or individual therapy, as determined by the clinical team. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18-55;
- Meeting DSM-5 criteria for alcohol use disorders;
- Withdrawing alcohol for less than 12 months;
- Ability to use computers;
- Signing informed consent;
Key exclusion criteria (4 listed)
- Having comorbidities of other neuropsychiatric diseases;
- Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- With a family history of mental illness
- Not familiar with computer operation, unable to complete assessment and treatment.
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 treatmentParticipants assigned to this condition were offered 10 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, and explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants. The treatment framework is semi-structured through human-computer interaction. The forms of interaction include inquiries, statements, recommendations summaries, and knowledge assessments. | Device | robot-assisted rehabilitation intelligent treatment |
| treatment as usualBoth groups will receive treatment as usual, including medication, exercise, and psychological education. | Other | robot-assisted rehabilitation intelligent treatment, treatment as usual |
Primary outcome
Desire for alcohol
Time frame: 3 months
The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).
8 secondary outcomes
Change Readiness and Treatment Eagerness
Time frame: 3 months
Impulsiveness
Time frame: 3 months
Anxiety
Time frame: 3 months
Depression
Time frame: 3 months
Perception of stress
Time frame: 3 months
Sleep Quality
Time frame: 3 months
coping style
Time frame: 3 months
use of alcohol
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
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 treatment as usual in people with Alcohol Use Disorder, 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 4 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 9 Jan 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desire for alcohol (time frame: 3 months). 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 9 Jan 2023.