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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
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.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
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.
Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
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.
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).
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.
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).
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.
Time frame: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
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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.
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).
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.
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).
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.
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
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.
Time frame: 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.
Time frame: Assessed at immediately post-intervention at week 3 (T1).