Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia
Discussion on the Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia Based on the Theory of "Heart Dominating Mind" and "Body-spirit Syncretism" in Traditional Chinese Medicine
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Aug 2022
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
August 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 26, 2022
August 1, 2022
10 months
February 22, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
change of the Scale for the Assessment of Negative Symptoms (SANS)
Negative symptoms will be evaluated using the Scale for the Assessment of Negative Symptoms (SANS). The scale made up for the lack of attention to negative symptoms in previous psychiatric rating scales. It contains five subscales: affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A total of 24 items were scored at 6 levels for each item.
Change from Baseline at 3 months
Secondary Outcomes (2)
change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Change from Baseline at 3 months
change of event-related potential P300 (ERP P300)
Change from Baseline at 3 months
Other Outcomes (10)
change of n-back task
Change from Baseline at 3 months
change of 36-item Short Form Health Survey（SF-36）
Change from Baseline at 3 months
change of Social-Adaptive Functioning Evaluation (SAFE)
Change from Baseline at 3 months
- +7 more other outcomes
Study Arms (2)
Control group
EXPERIMENTALdaily rehabilitation interventions
Interventional group
EXPERIMENTALdaily rehabilitation interventions and shen-based Qigong exercise
Interventions
including Naikan therapy, Morita therapy, group art therapy, group painting therapy
a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day
Eligibility Criteria
You may qualify if:
- Han Chinese population
- age ≥ 18 years
- education level ≥ 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination
- assessed by MINI 7.0 and satisfied with the diagnostic criteria for schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-5)
- patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months
- residual negative symptoms, with at least one item ≥ 2 on the negative subscale of PANSS (N1-N7)
- taking second generation antipsychotics
- no training history of traditional Chinese exercises
- agreement to participate in the study and willing to give written informed consent
You may not qualify if:
- having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases
- satisfied with the diagnostic criteria for other mental disorders based on DSM-5
- having alcohol or substance abuse/dependence
- having mental retardation(WAIS\<70) and/or severe cognitive impairment(MMSE\<24)
- having visual and / or hearing problems, unable to complete the relevant test
- electroconvulsive or repetitive transcranial magnetic stimulation(rTMS) therapy in the past 3 months
- currently enrolled or participated in other clinical studies in the past 3 months
- participating in regular exercise training in the past 6 months
- failure to sign or refuse to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Related Publications (2)
Shen H, Lian A, Wu Y, Zhou J, Liu Y, Zhu L, Zhang Y, Yi Z, Liu X, Fan Q. Shen-based Qigong Exercise improves cognitive impairment in stable schizophrenia patients in rehabilitation wards: a randomized controlled study. BMC Psychiatry. 2024 Nov 13;24(1):796. doi: 10.1186/s12888-024-06146-8.
PMID: 39538216DERIVEDLian A, Fan Q, Wang W, Liu Q, Shi J, Zhuang M, Li Y, Liu X. Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial. Contemp Clin Trials Commun. 2023 Oct 3;36:101214. doi: 10.1016/j.conctc.2023.101214. eCollection 2023 Dec.
PMID: 37842323DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qing Fan
Shanghai Mental Health Center
- STUDY CHAIR
Xiaodan Liu
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2022
First Posted
April 5, 2022
Study Start
August 16, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
October 26, 2022
Record last verified: 2022-08