Anxiety DisordersNCT07545070
The Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
A study testing AI-based rehabilitation treatment combined with standard treatment and Treatment as Usual (TAU) in people with Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- AI-based rehabilitation treatment combined with standard treatment and Treatment as Usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2026to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, MD, 0086-021-34289888 ext. 3193, drminzhao@smhc.org.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- AI-based rehabilitation treatment combined with standard treatment, Treatment as Usual (TAU)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based rehabilitation treatment combined with standard treatmentDevice
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.
Both groups will receive treatment as usual, including medication, exercise and psychological education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at immediately post-intervention at week 3 (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545070
- Sponsor's protocol ID
- MZhao-027
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Protocol Testing the Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07545070
- Acronym / sponsor ID
- MZhao-027
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-based rehabilitation treatment combined with standard treatment | Experimental | Device: AI-based rehabilitation treatment combined with standard treatment, Other: Treatment as Usual (TAU)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. |
| Treatment as usual | Other | Other: Treatment as Usual (TAU)Participants in the treatment-as-usual group were offered standard treatment at the mental health hospitals as determined by the clinical team. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based rehabilitation treatment combined with standard treatmentParticipants 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. | Device | AI-based rehabilitation treatment combined with standard treatment |
| Treatment as Usual (TAU)Both groups will receive treatment as usual, including medication, exercise and psychological education. | Other | AI-based rehabilitation treatment combined with standard treatment, Treatment as usual |
Primary outcome
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.
8 secondary outcomes
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 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 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 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 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 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).
Patient Global Impression of Improvement
Time frame: Assessed at immediately post-intervention at week 3 (T1).
System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ).
Time frame: Assessed at immediately post-intervention at week 3 (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based rehabilitation treatment combined with standard treatment and Treatment as Usual (TAU) in people with Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.