Anxiety Disorders
Conditions
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.
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
DEVICEAI-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.
OTHERTreatment as Usual (TAU)
Both groups will receive treatment as usual, including medication, exercise and psychological education.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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 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). | 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. |
| Change from baseline in functional impairment, as measured by the Sheehan Disability Scale (SDS). | 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. |
| Patient Global Impression of Improvement | 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. |
| System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ). | 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. |
Countries
China
Outcome results
None listed