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临床试验/NCT06832358
NCT06832358已完成不适用

Effect Evaluation of PERMA Positive Psychological Intervention Model in Parkinson's Disease Patients

First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)

研究概览

简要总结

This study aims to evaluate the impact of positive psychological intervention based on the PERMA model on Parkinson's disease patients by assessing their depression, quality of life, and related psychological indicators before and after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
42 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects must meet the clinical diagnostic criteria for primary Parkinson's disease
  • •Subjects must not have a history of depression or other significant illnesses (e.g., stroke, coronary heart and tumor disease)
  • •Subjects should have clear consciousness, effective communication capabilities, and basic comprehension and reading skills to complete routine assessments
  • •The diagnosis of depression adhered to the ' Chinese Classification and Diagnostic Criteria for Mental Disorders ' (Revised Third Edition)
  • •Subjectsshould not have schizophrenia
  • •Subjects should not have substance abuse (alcohol, tobacco or other psychoactive substances)

排除标准

  • •Subjects with significant mental or cognitive impairment that communication or completion of scale assessments
  • •Subjects exhibiting severe self-harm or suicidal tendencies
  • •Subjects with severe dysfunction of the heart, liver, kidney or other critical organs
  • •Subjects with contraindications for transcranial magnetic stimulation (such as cochlear implant, pacemaker, built-in pump, artificial metal heart valve, suspected metal in the eye or elevated intracranial pressure)
  • •Subjects with a history of epilepsy that is poorly controlled
  • •Subjects with Parkinson's disease who have undergone surgical treatment

研究组 & 干预措施

Study group

Experimental

The study group was treated with routine nursing combined with PERMA positive psychological intervention mode

干预措施: Routine nursing methods (Behavioral)

Study group

Experimental

The study group was treated with routine nursing combined with PERMA positive psychological intervention mode

干预措施: PERMA positive psychological intervention mode (Behavioral)

Control group

Active Comparator

The control group will receive routine nursing methods to ensure that patients receive standard medical support and treatment during the intervention period.

干预措施: Routine nursing methods (Behavioral)

结局指标

主要结局

the scores of Unified Parkinson's Disease Rating Scale(UPDRS)

时间窗: after one month of intervention

the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)

时间窗: after one month of intervention

the scores of Hamilton Depression Scale(HAMD)

时间窗: after one month of intervention

the scores of Hamilton Anxiety Scale(HAMA)

时间窗: after one month of intervention

the scores of Connor-Davidson Resilience Scale(CD-RISC)

时间窗: after one month of intervention

the scores of Pittsburgh Sleep Quality Index(PSQI)

时间窗: after one month of intervention

the scores of Mini-Mental State Examination(MMSE)

时间窗: after one month of intervention

the scores of Positive and Negative Affect Schedule (PANAS)

时间窗: after one month of intervention

the Newcastle Nursing Satisfaction Scale score

时间窗: after one month of intervention

the scores of Hamilton Depression Scale(HAMD)

时间窗: before the intervention

the scores of Hamilton Anxiety Scale(HAMA)

时间窗: before the intervention

the scores of Unified Parkinson's Disease Rating Scale(UPDRS)

时间窗: before the intervention

the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)

时间窗: before the intervention

the scores of Positive and Negative Affect Schedule (PANAS)

时间窗: before the intervention

the Newcastle Nursing Satisfaction Scale score

时间窗: before the intervention

the scores of Connor-Davidson Resilience Scale(CD-RISC)

时间窗: before the intervention

the scores of Pittsburgh Sleep Quality Index(PSQI)

时间窗: before the intervention

the scores of Mini-Mental State Examination(MMSE)

时间窗: before the intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meichun Shu

Doctor

First Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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