NCT05675553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

December 28, 2022

Last Update Submit

December 28, 2022

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Desire for alcohol

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

    3 months

Secondary Outcomes (8)

  • Change Readiness and Treatment Eagerness

    3 months

  • Impulsiveness

    3 months

  • Anxiety

    3 months

  • Depression

    3 months

  • Perception of stress

    3 months

  • +3 more secondary outcomes

Study Arms (2)

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.

Device: robot-assisted rehabilitation intelligent treatmentOther: 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.

Other: treatment as usual

Interventions

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.

robot-assisted rehabilitation intelligent treatment
treatment as usualOTHER

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

robot-assisted rehabilitation intelligent treatmenttreatment as usual

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 23000, China

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 9, 2023

Study Start

June 15, 2022

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

January 9, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)