The Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With AUD

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05675553
Collaborator
(none)
100
1
2
21.5
4.6

Study Details

Study Description

Brief 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 efficacy than traditional therapy in the treatment of alcohol use disorders.

Condition or Disease Intervention/Treatment Phase
  • Device: robot-assisted rehabilitation intelligent treatment
  • Other: treatment as usual
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: robot-assisted rehabilitation intelligent treatment

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
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.

Other: treatment as usual
Both groups will receive treatment as usual, including medication, exercise, and psychological education.

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
Both groups will receive treatment as usual, including medication, exercise, and psychological education.

Outcome Measures

Primary Outcome Measures

  1. Desire for alcohol [3 months]

    The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).

Secondary Outcome Measures

  1. Change Readiness and Treatment Eagerness [3 months]

    The secondary outcome includes participants' Change Readiness and Treatment Eagerness, measured by the Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES).

  2. Impulsiveness [3 months]

    The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).

  3. Anxiety [3 months]

    The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).

  4. Depression [3 months]

    The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).

  5. Perception of stress [3 months]

    The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).

  6. Sleep Quality [3 months]

    The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).

  7. coping style [3 months]

    The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).

  8. use of alcohol [3 months]

    The secondary outcome includes participants' use of alcohol.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Between the ages of 18-55;

  2. Meeting DSM-5 criteria for alcohol use disorders;

  3. Withdrawing alcohol for less than 12 months;

  4. Ability to use computers;

  5. Signing informed consent;

Exclusion Criteria:
  1. Having comorbidities of other neuropsychiatric diseases;

  2. Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.

  3. With a family history of mental illness

  4. Not familiar with computer operation, unable to complete assessment and treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mental Health Center Shanghai Shanghai China 23000

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT05675553
Other Study ID Numbers:
  • MZhao-011
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023