An interventional study of robot-assisted rehabilitation intelligent treatment and treatment as usual in Alcohol Use Disorder, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
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.
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Shanghai Mental Health Center is the lead sponsor of 271 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
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.
Device: robot-assisted rehabilitation intelligent treatment · Other: treatment as usual
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.
Other: treatment as usual
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.
Both groups will receive treatment as usual, including medication, exercise, and psychological education.
Desire for alcohol
The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).
Time frame: 3 months
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).
Time frame: 3 months
Impulsiveness
The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).
Time frame: 3 months
Anxiety
The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).
Time frame: 3 months
Depression
The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).
Time frame: 3 months
Perception of stress
The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).
Time frame: 3 months
Sleep Quality
The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).
Time frame: 3 months
coping style
The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).
Time frame: 3 months
use of alcohol
The secondary outcome includes participants' use of alcohol.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Dec 2023, 18 months after the start.
Of 459 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 18 months is below that.
Counting every sponsor, half of 482 studies reached it within 34 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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