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SchizophreniaNCT07557368

Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia

A study testing Gamified Digital Rehabilitation in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Schizophrenia is a severe and chronic mental disorder that profoundly impacts patients' psychological, social, and occupational functions. Cognitive impairment is a core symptom that severely limits daily living abilities. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Schizophrenia
What is being tested?
Gamified Digital Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
19 Apr 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Registered in the Shanghai Mental Health Information Management System and hospitalized in the designated district-level mental health center wards;
  • Schizophrenia patients meeting the diagnostic criteria of schizophrenia in the International Classification of Diseases (ICD-10);
  • 18 - 45 years old;
  • Good self-care ability;
  • Clinically stable (without acute exacerbation) for at least 1 week before enrollment, with a stable dose of antipsychotic drugs or other concomitant psychotropic drugs for at least 1 week;
  • No hand disabilities, and can use mobile phones or tablets normally;
Show all 10Show fewer
  • Have a primary school education or above;
  • Normal vision and hearing, or within the normal range after correction;
  • Own and be able to independently use a smart phone or other electronic devices;
  • Patients and their families have given informed consent to this study, and voluntarily cooperate to participate in the intervention and sign the informed consent form.

Who cannot join

  • not reside in Shanghai after discharge;
  • suffering from serious physical or brain organic diseases;
  • comorbid with other psychotic disorders.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Shanghai Mental Health Center

    Shanghai

    Jun Cai

    Recruiting

Other trials in China

About this study

Official title: Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia: A Randomized Controlled Trial[

Schizophrenia is a severe and chronic mental disorder that profoundly impacts patients' psychological, social, and occupational functions. Cognitive impairment is a core symptom that severely limits daily living abilities. Systematic rehabilitation is crucial for delaying disease progression and improving social functions.

Traditional rehabilitation typically relies on pharmacological treatments and conventional cognitive remediation therapies. However, cognitive training alone rarely translates spontaneously into real-world functional improvement; integration with functional skills training is generally required before meaningful gains in daily living are achieved. Furthermore, traditional interventions are typically delivered in contexts detached from patients' everyday lives and are often perceived as monotonous, resulting in poor treatment adherence and compromised long-term rehabilitation outcomes.

Read more

With the development of digital health technologies, gamified interventions offer new opportunities for psychiatric rehabilitation. Among these innovative approaches, integrating psychoeducation with interactive storytelling has shown unique advantages. Such immersive narrative contexts can effectively enhance patients' illness awareness, treatment motivation, and medication adherence. Nevertheless, existing digital tools still have room for improvement. On one hand, many applications are confined to static screen-based interactions, overlooking the elevated somatic disease burden and sedentary risks prevalent in this population. On the other hand, existing applications rarely successfully integrate cognitive interventions with coherent psychosocial interventions, making it difficult for cognitive improvements to genuinely translate into real-life skills.

To this end, the present study developed an interactive digital rehabilitation application specifically designed for individuals with schizophrenia. This intervention innovatively combines cognitive remediation with psychosocial rehabilitation through two distinct yet highly complementary modules: a sensory-motion cognitive module, which leverages the built-in motion-sensing capabilities of mobile devices to engage patients in moderate physical activity while performing cognitive tasks; and an interactive narrative module, encompassing medication management, symptom management, psychological recovery, and social rehabilitation. Through a randomized controlled trial, this study evaluates the practical effectiveness of this multimodal approach in improving patients' overall rehabilitation outcomes, ultimately seeking to provide a highly engaging rehabilitation pathway that facilitates the transfer of skills to daily life.

Read the detailed description

In this study, the investigators aimed to investigate the effectiveness of a multimodal digital intervention on the rehabilitation outcomes of inpatients with schizophrenia, with an 8-week intervention and a 24-month duration of follow up. The investigators hypothesized that patients assigned into the digital intervention group would show better improvement in cognitive functions, social function, and overall rehabilitation outcomes. The study protocol was approved by the Institutional Review Board in Shanghai Mental Health Center. Aim of the study: 1.1 To explore the effectiveness of the gamified somatosensory and narrative intervention in patients with schizophrenia. 1.2 The patients were followed up for 24 months to explore the long-term effects of the digital intervention . Introduction of the study: Patients aged 18 to 45 years who previously diagnosed as schizophrenia according to International Classification of Diseases 10th Revision (ICD-10) would receive routine psychiatric care in the hospital. The selected schizophrenic patients were randomly assigned into intervention group and control group . During the 8-week intervention period, the control group received routine inpatient psychiatric rehabilitation while the intervention group received additional gamified rehabilitation (including somatosensory cognitive games and interactive narrative games) three times a week, 30 minutes per session . Clinical assessments were conducted at baseline, 8 weeks (immediately post-intervention), and 1, 3, 6, 12, and 24 months post-intervention . A single-blind method was used, in which all the assessments were independently completed by trained investigators who didn't know the grouping . The MATRICS Consensus Cognitive Battery (MCCB), Social Disability Screening Schedule (SDSS), Brief Psychiatric Rating Scale (BPRS), Morisky Medication Adherence Scale (MMAS-8), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and World Health Organization Quality of Life Brief Version (WHOQOL-BREF) were measured at the designated time points during the study .

Conditions
Schizophrenia
Being tested
Gamified Digital Rehabilitation
Keywords
Gamified Rehabilitation, Schizophrenia, Cognitive, Psychosocial
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamified Digital RehabilitationOther

    A digital application consisting of two complementary modules:

    1. Somatosensory cognitive games utilizing the device's gyroscope to engage patients in moderate physical activity while completing cognitive tasks, consisting of 10 games set in a community background;
    2. Interactive narrative games divided into four modules: medication management, symptom management, psychological rehabilitation, and social rehabilitation, comprising a total of 24 stories. Patients complete one cognitive game and two narrative games per session.
Study groups in NCT07557368
Study groupRoleWhat they receive
Intervention Group (Gamified Digital Rehabilitation)ExperimentalParticipants in this group will receive an 8-week gamified digital rehabilitation intervention in addition to routine inpatient psychiatric care. The digital intervention comprises somatosensory cognitive games and interactive narrative games, administered for 30 minutes per session, three times a week .
Receives: Other: Gamified Digital Rehabilitation
Controlled groupNo interventionParticipants in this group will receive only routine inpatient psychiatric rehabilitation and care[8.1]. No additional digital game intervention will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MCCB

    Cognitive function is assessed using the MATRICS Consensus Cognitive Battery (MCCB) . The MCCB includes 9 standardized tests covering domains such as processing speed, attention, and working memory. The raw scores are converted into standardized T-scores (mean = 50, standard deviation = 10) based on normative data. Higher T-scores indicate better cognitive performance.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  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.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  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').

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  4. MMAS-8

    Medication adherence is assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) . The total score ranges from 0 to 8. A score of 8 indicates high adherence, 6 to less than 8 indicates medium adherence, and less than 6 indicates low adherence. Higher scores indicate better adherence to the prescribed medication regimen.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  5. SDSS

    Social functioning is assessed using the Social Disability Screening Schedule (SDSS) . The SDSS is a 10-item scale evaluating various aspects of social and occupational impairment in psychiatric patients. Each item is scored from 0 to 2. The total score ranges from 0 to 20, with lower scores indicating better social functioning and less social disability.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

Secondary outcomes (3)
  1. BPRS

    Psychiatric symptoms are assessed using the Brief Psychiatric Rating Scale (BPRS) . The BPRS consists of 18 items covering five factors: anxiety-depression, anergia, thought disturbance, activation, and hostile-suspiciousness. Each item is rated on a 7-point scale (1 = not present, 7 = extremely severe). The total score ranges from 18 to 126, with higher scores indicating more severe psychiatric symptoms.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  2. WHOQOL-BREF

    Quality of life is assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) . This 26-item instrument measures physical health, psychological health, social relationships, and environment domains. Higher scores indicate a better overall quality of life.

    Measured: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

  3. uMARS

    Satisfaction and engagement with the digital intervention are assessed using the User Version of Mobile Application Rating Scale (uMARS) . The uMARS includes 14 items across 3 dimensions (information, functionality, user engagement) rated on a 5-point scale. Higher scores indicate better app quality and higher user satisfaction. (Note: This measure is only evaluated for participants in the intervention group).

    Measured: 8 weeks (immediately post-intervention, T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start19 Apr 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07557368
Sponsor's protocol ID
JCai2
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gamified Digital Rehabilitation in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weibo Zhang (86-13764694223, zhangweibo600@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCCB (time frame: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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