Positive Psychological Intervention for Parkinson's Disease Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson
• Intervention / Treatment: Behavioral: Routine nursing methods; Behavioral: PERMA positive psychological intervention mode

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Wenzhou, China
    • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study group was treated with routine nursing combined with PERMA positive psychological intervention mode	Behavioral: Routine nursing methods; 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.; Behavioral: PERMA positive psychological intervention mode; (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.
Active Comparator: Control group; The control group will receive routine nursing methods to ensure that patients receive standard medical support and treatment during the intervention period.	Behavioral: Routine nursing methods; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: Meichun Shu2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No