Positive Psychological Intervention for Parkinson's Disease Patients
Effect Evaluation of PERMA Positive Psychological Intervention Model in Parkinson's Disease Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
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
Study Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedFebruary 18, 2025
February 1, 2025
1 year
February 12, 2025
February 12, 2025
Conditions
Outcome Measures
Primary Outcomes (18)
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
before the intervention
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
after one month of intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
before the intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
after one month of intervention
the scores of Hamilton Depression Scale(HAMD)
before the intervention
the scores of Hamilton Depression Scale(HAMD)
after one month of intervention
the scores of Hamilton Anxiety Scale(HAMA)
before the intervention
the scores of Hamilton Anxiety Scale(HAMA)
after one month of intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
before the intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
after one month of intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
before the intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
after one month of intervention
the scores of Mini-Mental State Examination(MMSE)
before the intervention
the scores of Mini-Mental State Examination(MMSE)
after one month of intervention
the scores of Positive and Negative Affect Schedule (PANAS)
before the intervention
the scores of Positive and Negative Affect Schedule (PANAS)
after one month of intervention
the Newcastle Nursing Satisfaction Scale score
before the intervention
the Newcastle Nursing Satisfaction Scale score
after one month of intervention
Study Arms (2)
Study group
EXPERIMENTALThe study group was treated with routine nursing combined with PERMA positive psychological intervention mode
Control group
ACTIVE COMPARATORThe control group will receive routine nursing methods to ensure that patients receive standard medical support and treatment during the intervention period.
Interventions
According to their condition, they receive individualized drug treatment, including the main drugs of Parkinson's disease (such as dopamine replacement drugs) and combined antidepressant drugs. Secondly, regular follow-up evaluations will be conducted to monitor disease progression and drug side effects. At the same time, patients and their families will receive health education on Parkinson's disease and depression.The patients would receive basic psychological support. Medical staff will encourage patients to express their emotions and pay attention to their psychological state, which will help alleviate anxiety and depression. Medical staff will provide patients with information about local support organizations and social groups, and encourage patients to participate in related activities to increase social interaction and emotional support.
(1) Formation of an intervention team.(2) Development and execution of interventions.The study group participated in a series of positive psychology workshop involving interviews and exercises aligned with the PERMA model as part of their routine health education. Each participant took part in individualized interviews focused on two specific topics each week until all subjects were covered, with each session lasting between 30 to 50 minutes. This interview phase continued for one month, conducted in the hospital ward.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 18, 2025
Study Start
February 1, 2022
Primary Completion
February 1, 2023
Study Completion
April 1, 2023
Last Updated
February 18, 2025
Record last verified: 2025-02