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NCT Number: NCT07545070

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

AI-based rehabilitation treatment combined with standard treatment

Device

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.

Treatment as usual (TAU)

Other

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

Primary outcomes

  1. Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

Secondary outcomes

  1. Change from baseline in depression status, as assessed by the Patient Health Questionnaire-9 (PHQ-9).

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

  2. Change from baseline in social anxiety symptoms, as measured by the Liebowitz Social Anxiety Scale (LSAS).

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

  3. Change from baseline in emotion regulation ability, as measured by the Emotion Regulation Questionnaire (ERQ).

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

  4. Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).

    Time frame: 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.

  5. Change from baseline in insomnia severity, as assessed by the Insomnia Severity Index (ISI).

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

  6. Change from baseline in functional impairment, as measured by the Sheehan Disability Scale (SDS).

    Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).

    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.

  7. Patient Global Impression of Improvement

    Time frame: Assessed at immediately post-intervention at week 3 (T1).

    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.

  8. System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ).

    Time frame: Assessed at immediately post-intervention at week 3 (T1).

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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