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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Treatment as Usual (TAU)

    Other intervention

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

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: AI-based rehabilitation treatment combined with standard treatmentExperimental treatment 2 interventions
Group B: Treatment as usualOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

Sponsors and contacts

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