The Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-based rehabilitation treatment combined with standard treatment, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Anxiety Disorders. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial Protocol Testing the Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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).]
Secondary outcome measures (8)
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT07545070 · MZhao-027