Prediction and Intervention Effect of Rehabilitation Status for Severe Mental Disorder Patients Based on Multimodal Analysis and AI Agents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center

About this trial

Mental health issues represent a major public health and social problem that significantly impacts economic and social development. Compared to other diseases, mental disorders can impair various aspects of a patient' s life, including psychological, social, occupational, and educational functions, affecting their quality of life and daily living abilities. Particularly, severe mental disorders tend to have a chronic course, often resulting in diminished social functions and social withdrawal, making it difficult for patients to integrate into society. Repeated, systematic, and comprehensive rehabilitation training for patients with severe mental disorders can effectively control or delay disease recurrence, improve social functions, enhance quality of life, and facilitate patients' reintegration into society.

In recent years, the scope of mental disorder rehabilitation has expanded to include enhancing patients' social functions and promoting their integration into society. Vocational rehabilitation and social skills training are widely used in the rehabilitation treatment of patients with severe mental disorders, and some physical intervention methods, such as neurofeedback training, have also proven to be significantly effective in the rehabilitation process. However, traditional rehabilitation techniques often lack specificity and fail to meet individualized needs of patients. Additionally, the rehabilitation process lacks long-term monitoring, making it challenging to continuously assess and adjust patients' rehabilitation outcomes. Furthermore, the assessment of rehabilitation effectiveness mainly relies on patients' subjective feelings and clinical observations, lacking high-quality evidence. Therefore, there is an urgent need to introduce new rehabilitation technologies and scientifically evaluate their effectiveness to address the shortcomings of traditional methods and provide more personalized, precise, and effective rehabilitation support.

With the rise of digital health technologies, the field of mental health rehabilitation has encountered new opportunities. Compared to traditional therapies, digital health is revolutionizing the healthcare industry, moving away from traditional approaches to healthcare management to real-time personalized monitoring and therapeutic care.Technologies such as remote monitoring, virtual reality, and computer-assisted cognitive correction therapy are increasingly applied in rehabilitation. However, these methods still need improvements in data management and integration capabilities. A large amount of data accumulates in systems, recording only the training process and real-time effects of patients, without further evaluating their rehabilitation status, leading to resource waste. Therefore, there is an urgent need to develop a digital rehabilitation model that better meets the genuine needs of patients with severe mental disorders.

This study aims to integrate multimodal technology, reinforcement learning, and agent-based modeling (ABM) into the research of mental health rehabilitation to more accurately assess and predict the rehabilitation status of mental disorder patients and to more effectively guide and support decision-making in mental rehabilitation treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Registered in the Shanghai Mental Health Information Management System,

Diagnosed patients with one of the six severe mental disorders: schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, mental disorder due to epilepsy, and mental retardation accompanied by mental disorder,

Aged between 18 and 65 years old, ④ Normal vision or hearing, or within the normal range after correction, ⑤ Patients or their families have provided informed consent for this study and signed the informed consent form.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gamified Digital Rehabilitation

    Other intervention

    The gamification intervention measures are as follows: Currently, the initial version of the community mental health rehabilitation interactive game mainly focuses on six dimensions of medication management, including the importance of taking medication, identifying and dealing with adverse reactions to antipsychotic drugs, learning self-management of medication, assessing the effectiveness of medication treatment, long-term management of medication treatment, and discussing issues related to medication effects with medical staff. Next, we will continue to design a series of games themed on symptom management and psychological rehabilitation, and implement game-based digital rehabilitation interventions for patients in the intervention group based on these games.

  • Routine Care

    Behavioral

    Receive regular psychiatric medication treatment and regular community rehabilitation services, including regular follow-ups, rehabilitation guidance, and community education,etc.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Gamified Digital Rehabilitation)Experimental treatment 2 interventions
Group B: Control Group (Routine Care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

BPRS reduction rate

The Brief Psychiatric Rating Scale (BPRS) was used to measure the presence and severity of psychiatric symptoms entailing positive symptoms, general psychopathology, and affective symptoms (e.g., thought disturbance, emotional withdrawal, hostility, and suspiciousness) for patients with mental illness, particularly schizophrenia. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = 'not present' to 7 = 'extremely severe', with scores ranging from 18 to 126 (achieved through summing the item scores). Higher scores indicated more severity of psychiatric symptoms. Reduction rate was calculated using the following formula: reduction rate= (Score before treatment-Score after treatment)/(Score before treatment-18) × 100%. A reduction rate of BPRS score \> 25% was considered as a clinically meaningful improvement.

Time frame
Baseline (pre-intervention), immediately post-intervention (3 months), 1-month follow-up (4 months), 3-month follow-up (6 months) and 6-month follow-up (9 months).

Secondary outcomes

1

MMAS-8

The 8-item Morisky medicationadherence scale is the most widely used medication compliance assessment scale, which has been applied to patients with multiple chronic diseases and has been translated into different languages.

Time frame
Baseline (pre-intervention), immediately post-intervention (3 months), 1-month follow-up (4 months), 3-month follow-up (6 months) and 6-month follow-up (9 months).
2

GAD-7

The Generalized Anxiety Disorder Screener (GAD-7) is a brief, 7-item self-report measure for anxiety symptoms in adolescents and adults. Although developed primarily as a screening tool for GAD, it can also be used as a diagnostic tool to monitor changes in symptoms over time, and as a screener for social anxiety, panic disorder, and post-traumatic stress disorder. Each item is rated on a likert-type scale from zero ('not at all') to three ('nearly every day'), with total scores ranging from 0 to 21.

Time frame
Baseline (pre-intervention), immediately post-intervention (3 months), 1-month follow-up (4 months), 3-month follow-up (6 months) and 6-month follow-up (9 months).
3

PHQ-9

The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening , diagnosing, monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. The PHQ -9 is brief and useful in clinical practice. The PHQ -9 can be administered repeatedly , which can reflect improvement or worsening of depression in response to treatment .Each item is rated on a likert-type scale from zero ('not at all') to three ('nearly every day').

Time frame
Baseline (pre-intervention), immediately post-intervention (3 months), 1-month follow-up (4 months), 3-month follow-up (6 months) and 6-month follow-up (9 months).
4

WHOQOL-BREF

The WHO Quality of Life Scale-Brief (WHOQOL-BREF) was developed by the Word Health Organisation as a quality of life assessment that would be applicable cross-culturally. It is a 26 item self report measure, especially useful for measuring outcomes with adults with a psychosocial disability. The WHOQOL-BREF measures four factors: physical health, psychological Health, social relationships, and environment. The total score is presented between 26 and 156, where higher scores represent higher levels of quality of life.

Time frame
Baseline (pre-intervention), immediately post-intervention (3 months), 1-month follow-up (4 months), 3-month follow-up (6 months) and 6-month follow-up (9 months).

Other outcomes

Sponsors and contacts

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Shanghai Mental Health Center

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Collaborator