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Comparing the effectiveness of mindfulness group therapy, cognitive rehabilitation and drug therapy on reducing non-motor symptoms and quality of life of Parkinson's patients.

Protocol summary

Study aim
Determining the difference in the effectiveness of mindfulness group therapy , cognitive rehabilitation and drug therapy on the reduction of non-motor symptoms and quality of life of patients with Parkinson's disease
Design
115 / 5,000 A clinical trial with a control group, with parallel groups, no blind strain, randomized, was conducted on 54 patients.
Settings and conduct
The samples used were Parkinson's patients referred to Imam Reza Clinic, Shiraz, Department of Neurology under the supervision of Dr. Vahid Reza Ostovan, psychological interventions with a semi-experimental method with a pre-test-post-test design with a three-month follow-up with the control group. Mere drug therapy) was done by me in Mehrabani Clinic. After determining the sample, they were placed in three groups of 18 people using the integrated Parkinson's rating scale.
Participants/Inclusion and exclusion criteria
Parkinson's disease diagnosis, patient permit, absence of psychosis and dementia , and not participating in other psychological courses
Intervention groups
Three intervention groups while receiving medication, one of them received the treatment of the third wave of behaviorism, mindfulness, and the second group received cognitive rehabilitation of the second wave of behaviorism, and the control group received only drug therapy. The experimental groups received these treatments in order to reduce non-motor symptoms and They received an increase in the quality of life.
Main outcome variables
Non-motor symptoms, quality of life, depression, anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240727062560N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: retrospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Mohammad Hossein Arab
Name of organization / entity
Islamic Azad Univercity Bushehr brunch
Country
Iran (Islamic Republic of)
Phone
+98 71 3844 9461
Email address
mharabshz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2023-07-22, 1402/04/31
Trial completion date
2023-11-22, 1402/09/01
Scientific title
Comparing the effectiveness of mindfulness group therapy, cognitive rehabilitation and drug therapy on reducing non-motor symptoms and quality of life of Parkinson's patients.
Public title
The effect of non-pharmacological treatments on the non-motor symptoms of Parkinson patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Parkinson's disease by a neurologist , Patient permit ability and skill in writing and reading Absence of psychosis and dementia
Exclusion criteria:
Incidence of dementia and psychosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Actual sample size reached: 54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple random method will be used. The random list will be prepared through the random function (RAND) in Excel
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University Bushehr brunch
Street address
No 1/ب ,west Fajr Blvd,. Valfajr Town
City
Shiraz
Province
Fars
Postal code
7176913218
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
IR.BPUMS.REC.1402.079

Health conditions studied

1

Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Decreasing scores in the questionnaire of non-motor symptoms of Parkinson's patients
Timepoint
Measurement time before the intervention and three months after the treatment
Method of measurement
questionnaire of non-motor symptoms of Parkinson's patients

2

Description
Decreased scores in the Beck Anxiety Questionnaire
Timepoint
Measurement time before the intervention and three months after the treatment
Method of measurement
Beck Anxiety Questionnaire

3

Description
Decreased scores in the Beck ِDepression Questionnaire
Timepoint
Measurement time before the intervention and three months after the treatment
Method of measurement
Beck ِDepression Questionnaire

4

Description
Increasing the score of the 39-question quality of life questionnaire for Parkinson's patients
Timepoint
Measurement time before the intervention and three months after the treatment
Method of measurement
quality of life questionnaire for Parkinson's patients

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: 7 90-minute group therapy sessions are held at Mehrabani Counseling Center. In group meetings, after creating therapeutic motivation and a sense of trust between group members, the rules and techniques of therapeutic methods are taught.
Category
Treatment - Other

2

Description
Intervention group 2: In 7 90-minute sessions, cognitive rehabilitation group therapy will be held at Mehrabani Counseling Center. In group meetings, after creating therapeutic motivation and a sense of trust between group members, the rules and techniques of therapeutic methods are taught.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Imam Reza Clinic
Full name of responsible person
Dr Moloud Keykhosravani
Street address
No, 1/ب Valfajr Town
City
Shiraz
Province
Fars
Postal code
7176913218
Phone
+98 930 712 3131
Email
mharabshz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mehrabani Clinic
Full name of responsible person
Mandana Homayoni Meymandi
Street address
Motahhari Blvd
City
Shiraz
Province
Fars
Postal code
7176913218
Phone
+98 930 712 3131
Email
mharabshz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mohammad Hossein Arab
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hossein Arab
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No, 1/B. west Fajr Blvd, Valfajr Town
City
Shiraz
Province
Fars
Postal code
7176913218
Phone
+98 71 3844 9461
Email
mharabshz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hossein Arab
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No, 1/B. west Fajr Blvd, Valfajr Town
City
Shiraz
Province
Fars
Postal code
7176913218
Phone
+98 71 3844 9461
Email
mharabshz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hossein Arab
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No, 1/B. west Fajr Blvd, Valfajr Town
City
Shiraz
Province
Fars
Postal code
7176913218
Phone
+98 71 3844 9461
Email
mharabshz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data, such as information related to the main outcome or similar, can be shared
When the data will become available and for how long
Beginning of the access period from 2025
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
General data is for guidance only
From where data/document is obtainable
I am Dr. Mohammad Hossein Arab-Merhabani Counseling Center-Shiraz, Motahari Blvd., Hundred Gol Building 0098 9307123131
What processes are involved for a request to access data/document
The applicant should send his/her request to my email with a complete explanation of why and how to do the work mharabshz@gmail.com
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