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Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients

Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients - Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050885
Enrollment
130
Registered
2023-04-19
Start date
2023-04-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Intervention: Cognitive remedial therapy (NEAR) + exercise therapy (aerobic exercise) + usual treatment group Control: Cognitive remedial therapy (NEAR) + usual treatment group

Sponsors

Department of Psychiatry, Tohoku University Hospital Department of Psychiatry, Graduate School of Medicine, Tohoku University
Lead Sponsor
Miyagi Psychiatric Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with schizophrenia who are outpatients at Tohoku University Hospital Psychiatry Department and Miyagi Psychiatric Medical Center (2) Subjects who have been successfully treated with drugs and judged by the attending psychiatrist to be in a state of no significant hallucinations or delusions. Any stage is acceptable. (3) Age between 20 and 40 (at the time of registration). IQ>70 (4) Regardless of gender (5)Patients who have given their voluntary written consent after receiving a sufficient explanation for participating in this study. (6) Patients who are already registered with daycare in both hospitals or who are considering registration with daycare and who are judged by attending psychiatrists to require treatment at daycare.

Exclusion criteria

Exclusion criteria: (1) Those who have a medical history or undergoing treatment at the time of first registration as follows; substance dependence, head injury, lifestyle-related diseases (hypertension, hyperlipidemia, diabetes), or vascular disorders (brain, cardiac, etc.), eye disease (cataract, glaucoma, etc.) or severe visual impairment (myopia, hyperopia, etc.), diagnosis of dementia, or those who score 21 points or less on the cognitive function evaluation MMSE (Mini-Mental State Examination). (2) Subjects whose exercise is restricted by a doctor for some reason (orthopedic or medical reasons) at the time of first registration. (3)Patients judged by the attending psychiatrist to be significantly lacking in consent due to marked hallucinations/delusions or thought disorders.

Design outcomes

Primary

MeasureTime frame
(1) Evaluation of neurocognitive/social cognition function: The Brief Assessment of Cognition in Schizophrenia Japanese version (BACS.J), Social Cognition Screening Questionnaire Japanese version (SCSQ.J) (2) Psychiatric symptoms assessment: Global Assessment of Functioning (GAF), Positive and Negative Syndrome Scale (PANSS) (3) Evaluation of quality of life (QOL): Schizophrenia Quality of Life Scale Japanese version (SQLS.J) (4) Retinal layers: Measure the retinal nerve fiber layer (RNFL), ganglion cell layer complex (GCC), macular volume, macular thickness, etc by SD-OCT. Implemented only at Tohoku University Hospital. (5) Evaluation of Body composition: body fat percentage, muscle mass, basal metabolic rate, etc. (measured by body composition meter)

Secondary

MeasureTime frame
1) Evaluation of self-stigma: The Internalized Stigma of Illness Scale, Japanese version (ISMI.J) 2) Evaluation of personality tendency: Ten Item Personality Inventory Japanese versions (TIPI.J), The Autism-Spectrum Quotient Japanese versions (AQ.J)

Countries

Japan

Contacts

Public ContactHiroshi Komatsu

Tohoku University Hospital Department of Psychiatry

hkomatsu1019@gmail.com022-717-7262

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026