The Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders

A Randomized Controlled Trial Protocol Testing the Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders

The trail aimed to test the efficacy of AI-based rehabilitation treatment in patients with anxiety disorders. Specifically, the objective of this trial is to determine whether the AI-based rehabilitation combined with treatment as usual is more effective than treatment as usual alone in improving outcomes in patients with anxiety disorders.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Device: AI-based rehabilitation treatment combined with standard treatment; Other: Treatment as Usual (TAU)

Detailed Description

This study aims to evaluate an AI-based rehabilitation system for delivering psychological intervention to patients with anxiety disorders. A randomized controlled single-blind trial design was employed to compare the clinical outcomes between patients receiving AI-based rehabilitation treatment combined with standard treatment and those receiving standard treatment alone, in order to evaluate the efficacy of the AI-based rehabilitation system. Additionally, system usability and acceptability will be assessed in the intervention group using standardized scales, evaluating ease of use, task efficiency, interaction quality, and overall user satisfaction, thereby providing evidence to support the clinical integration of AI technology in mental health interventions.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Mental Health Center
      • Contact: Min Zhao, MD; Phone Number: 3193 0086-021-34289888; Email: drminzhao@smhc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

1. Subjects with anxiety disorders

• Inclusion Criteria:

  • In accordance with ICD-11 for Anxiety Disorders;
  • Between the ages of 18-60;
  • Completed at least 9 years of education;
  • Ability to use computers or smartphone;
  • Native Chinese speaker;
  • Signing informed consent.

• Exclusion Criteria:

  • With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment;
  • Use of cognitive-enhancing medications within the past 6 months;
  • With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-based rehabilitation treatment combined with standard treatment; Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise and psychological education. Rehabilitation treatment will be delivered to participants in the testing group through an AI-based intervention system.	Device: AI-based rehabilitation treatment combined with standard treatment; Participants were offered a 3-week psychological intervention , delivered by the AI-based rehabilitation system. The system contains 12 core topics, such as basic knowledge and emotion regulation, cognitive restructuring, behavior activation, interpersonal communication skills, mindfulness and sleep, and relaxation training. The intervention schedule was 4 sessions per week, each lasting approximately 20 minutes, for a total of 12 sessions.; Other: Treatment as Usual (TAU); 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 as determined by the clinical team.	Other: Treatment as Usual (TAU); Both groups will receive treatment as usual, including medication, exercise and psychological education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)	Change in anxiety symptoms, measured by reduction in total score and rate of score reduction on the Generalized Anxiety Disorder 7-item Scale (GAD-7). The GAD-7 total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in depression status, as assessed by the Patient Health Questionnaire-9 (PHQ-9).	Change in depressive symptoms, measured by reduction in total score and rate of score reduction on the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Change from baseline in social anxiety symptoms, as measured by the Liebowitz Social Anxiety Scale (LSAS).	Change in social anxiety symptoms, measured by reduction in total score and rate of score reduction on the Liebowitz Social Anxiety Scale (LSAS). The LSAS total score ranges from 0 to 144, with higher scores indicating greater severity of social anxiety symptoms.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Change from baseline in emotion regulation ability, as measured by the Emotion Regulation Questionnaire (ERQ).	Change in emotion regulation ability, measured by total score on the Emotion Regulation Questionnaire (ERQ). The ERQ total score ranges from 0 to 70, with higher scores indicating greater use of emotion regulation strategies and better emotion regulation ability.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).	Change in resilience level, measured by total score on the Connor-Davidson Resilience Scale-10 (CD-RISC-10). The CD-RISC-10 total score ranges from 0 to 40, with higher scores indicating greater psychological resilience.	Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).
Change from baseline in insomnia severity, as assessed by the Insomnia Severity Index (ISI).	Change from baseline in insomnia severity, measured by reduction in total score on the Insomnia Severity Index (ISI). The ISI total score ranges from 0 to 28, with higher scores indicating greater severity of insomnia symptoms.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Change from baseline in functional impairment, as measured by the Sheehan Disability Scale (SDS).	Change from baseline in functional impairment, measured by reduction in total score on the Sheehan Disability Scale (SDS). The SDS total score ranges from 0 to 30, with higher scores indicating greater functional impairment.	Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Patient Global Impression of Improvement	Patient-reported global impression of improvement, as assessed by the Patient Global Impression of Improvement (PGI-I). The PGI-I is a 7-point scale ranging from "very much improved" to "very much worse", reflecting the participant's subjective perception of change in overall condition.	Assessed at immediately post-intervention at week 3 (T1).
System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ).	System usability and acceptability, as assessed in the intervention group using the Chinese version of the Mobile App Usability Questionnaire (MAUQ). The MAUQ evaluates ease of use, task efficiency, interaction quality, and overall user satisfaction.	Assessed at immediately post-intervention at week 3 (T1).

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Therapeutics
• Other Study ID Numbers: MZhao-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No