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Completed

NCT Number: NCT06832358

Positive Psychological Intervention for 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.

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Key information

Conditions

Parkinson

Age range

42 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine nursing methods

Behavioral

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.

PERMA positive psychological intervention mode

Behavioral

(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.

Primary outcomes

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

    Time frame: before the intervention

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

    Time frame: after one month of intervention

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

    Time frame: before the intervention

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

    Time frame: after one month of intervention

  5. the scores of Hamilton Depression Scale(HAMD)

    Time frame: before the intervention

  6. the scores of Hamilton Depression Scale(HAMD)

    Time frame: after one month of intervention

  7. the scores of Hamilton Anxiety Scale(HAMA)

    Time frame: before the intervention

  8. the scores of Hamilton Anxiety Scale(HAMA)

    Time frame: after one month of intervention

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

    Time frame: before the intervention

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

    Time frame: after one month of intervention

  11. the scores of Pittsburgh Sleep Quality Index(PSQI)

    Time frame: before the intervention

  12. the scores of Pittsburgh Sleep Quality Index(PSQI)

    Time frame: after one month of intervention

  13. the scores of Mini-Mental State Examination(MMSE)

    Time frame: before the intervention

  14. the scores of Mini-Mental State Examination(MMSE)

    Time frame: after one month of intervention

  15. the scores of Positive and Negative Affect Schedule (PANAS)

    Time frame: before the intervention

  16. the scores of Positive and Negative Affect Schedule (PANAS)

    Time frame: after one month of intervention

  17. the Newcastle Nursing Satisfaction Scale score

    Time frame: before the intervention

  18. the Newcastle Nursing Satisfaction Scale score

    Time frame: after one month of intervention

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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