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

NCT07545070 | Not Yet Recruiting

• 1 other identifier: MZhao-027
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  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).

  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).

  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 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).

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

Study Arms (2)

AI-based rehabilitation treatment combined with standard treatment

EXPERIMENTAL

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; Other: Treatment as Usual (TAU)

Treatment as usual

OTHER

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)

Interventions

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.

AI-based rehabilitation treatment combined with standard treatment

Treatment as Usual (TAU) OTHER

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

AI-based rehabilitation treatment combined with standard treatment; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)