ParkinsonNCT06832358
Positive Psychological Intervention for Parkinson's Disease Patients
A study testing Routine nursing methods and PERMA positive psychological intervention mode in people with Parkinson, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 81 years
- Conditions the study is for
- Parkinson
- What is being tested?
- Routine nursing methods and PERMA positive psychological intervention mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson
- Being tested
- Routine nursing methods, PERMA positive psychological intervention mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine nursing methodsBehavioural
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 modeBehavioural
(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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group was treated with routine nursing combined with PERMA positive psychological intervention mode Receives: Behavioral: Routine nursing methods; Behavioral: 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. Receives: Behavioral: Routine nursing methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
Measured: before the intervention
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
Measured: after one month of intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
Measured: before the intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
Measured: after one month of intervention
the scores of Hamilton Depression Scale(HAMD)
Measured: before the intervention
the scores of Hamilton Depression Scale(HAMD)
Measured: after one month of intervention
the scores of Hamilton Anxiety Scale(HAMA)
Measured: before the intervention
the scores of Hamilton Anxiety Scale(HAMA)
Measured: after one month of intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
Measured: before the intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
Measured: after one month of intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
Measured: before the intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
Measured: after one month of intervention
the scores of Mini-Mental State Examination(MMSE)
Measured: before the intervention
the scores of Mini-Mental State Examination(MMSE)
Measured: after one month of intervention
the scores of Positive and Negative Affect Schedule (PANAS)
Measured: before the intervention
the scores of Positive and Negative Affect Schedule (PANAS)
Measured: after one month of intervention
the Newcastle Nursing Satisfaction Scale score
Measured: before the intervention
the Newcastle Nursing Satisfaction Scale score
Measured: after one month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Feb 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meichun Shu, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832358
- Sponsor's protocol ID
- Meichun Shu2
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of PERMA Positive Psychological Intervention Model in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT06832358
- Acronym / sponsor ID
- Meichun Shu2
- Conditions
- Parkinson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Routine nursing methods, Behavioral: PERMA positive psychological intervention modeThe study group was treated with routine nursing combined with PERMA positive psychological intervention mode |
| Control group | Active comparator | Behavioral: Routine nursing methodsThe control group will receive routine nursing methods to ensure that patients receive standard medical support and treatment during the intervention period. |
Who may qualify
- Ages
- 42 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine nursing methodsAccording 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. | Behavioural | Control group, Study group |
| 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. | Behavioural | Study group |
Primary outcome
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
Time frame: before the intervention
the scores of Unified Parkinson's Disease Rating Scale(UPDRS)
Time frame: after one month of intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
Time frame: before the intervention
the scores of Parkinson's Disease Quality of Life Scale(PDQ-39)
Time frame: after one month of intervention
the scores of Hamilton Depression Scale(HAMD)
Time frame: before the intervention
the scores of Hamilton Depression Scale(HAMD)
Time frame: after one month of intervention
the scores of Hamilton Anxiety Scale(HAMA)
Time frame: before the intervention
the scores of Hamilton Anxiety Scale(HAMA)
Time frame: after one month of intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
Time frame: before the intervention
the scores of Connor-Davidson Resilience Scale(CD-RISC)
Time frame: after one month of intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
Time frame: before the intervention
the scores of Pittsburgh Sleep Quality Index(PSQI)
Time frame: after one month of intervention
the scores of Mini-Mental State Examination(MMSE)
Time frame: before the intervention
the scores of Mini-Mental State Examination(MMSE)
Time frame: after one month of intervention
the scores of Positive and Negative Affect Schedule (PANAS)
Time frame: before the intervention
the scores of Positive and Negative Affect Schedule (PANAS)
Time frame: after one month of intervention
the Newcastle Nursing Satisfaction Scale score
Time frame: before the intervention
the Newcastle Nursing Satisfaction Scale score
Time frame: after one month of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine nursing methods and PERMA positive psychological intervention mode in people with Parkinson, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the scores of Unified Parkinson's Disease Rating Scale(UPDRS) (time frame: before the intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.