NCT06832358

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 12, 2025

Last Update Submit

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

EXPERIMENTAL

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

Behavioral: Routine nursing methodsBehavioral: PERMA positive psychological intervention mode

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.

Behavioral: Routine nursing methods

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.

Control groupStudy group

(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.

Study group

Eligibility Criteria

Age42 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations