- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208021
The Effect of Psychoeducation Program on Healthy Living Behaviors
January 26, 2022 updated by: Mahinur Betül Çalışkan, Saglik Bilimleri Universitesi
The Effect of Individual Psychoeducation Program Based on the Health Promotion Model on the Healthy Living Behaviors of Individuals With Schizophrenia
1.031 / 5.000 Çeviri sonuçları This research was planned to determine the effect of health protection and promotion program based on motivational interviewing based on Pender's Health Promotion Model on healthy lifestyle behaviors of individuals with schizophrenia.
When the national and international literature is examined, it is known that there are descriptive studies on the physical health of individuals with mental disorders, and interventional intervention programs under the leadership of psychiatric nurses for the protection and development of the physical health of individuals with mental disorders are very limited.
In this context, psychiatric nurses act as a bridge between mental and physical health for patients.
It is thought that this study, which will be conducted to evaluate the healthy lifestyle behaviors of individuals with schizophrenia, of the Health Promotion Model and motivational interview-based health protection and promotion program will contribute to the literature, provide data for future studies, and be an applicable model for TRSMs.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Research Istanbul Bakirkoy Prof. Dr.
In Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital Bakırköy Community Mental Health Center, the experimental research design was carried out with a pretest and posttest control group.
The study population of this study consisted of patients aged 18-65 years who were diagnosed with schizophrenia and other psychotic disorders (N=502).
The sample of the study consisted of patients diagnosed with schizophrenia and other psychotic disorders who met the sampling criteria determined in the study (n=52).
In the Power analysis of the research, the sample size was determined as 2 groups, with 26 people as the experimental group and 26 people as the control group, with a total of 52 people in the 95% confidence interval.
In the study, 52 patients diagnosed with schizophrenia and other psychotic disorders who met the sample selection criteria and volunteered to participate in the study were divided into experimental and control groups using simple random sampling technique.
As data collection tools in the research; Personal Information Form, Healthy Life Style Behavior Scale II, Health Improvement Profile, Anthropometric Measurements and Vital Findings and Stage of Change Diagnosis Form were used.
The implementation of the research was completed in four stages.
In the first stage, the "Health Promotion Model and Motivational Interview-Based Health Protection and Promotion Program" was developed by the researcher in line with the literature review.
In the second stage, after the program was introduced to all participants who met the inclusion criteria and their written consent was obtained, pre-tests including the variables of the research were applied, and then the participants were assigned to the experimental and control groups by randomization method.
Sessions were held in the form of individual interviews due to the pandemic and social distance conditions.
In the third stage, the Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program were applied to the experimental group, which consisted of 6 sessions and lasted an average of 60-120 minutes to discuss the warm-up period and the main themes of the sessions in each individual session.
A summary of the previous session was made to remember what was done in the first 5-10 minutes of each session.
"Weekly Nutrition Follow-up Form", "Weekly Step Count Follow-up Form", "Weekly Stress Follow-up Form", "Weekly Leisure Activities Follow-Up Form" and "Weekly Sleep Diary" prepared by the researcher for the experimental group participants were handed over to the patients as homework.
They were asked to fill it out weekly and bring it to their next session.
No intervention was made to the patients in the control group during the six-week period.
During this process, both experimental and control group patients continued their routine treatments including drug treatments, doctor's controls, psychoeducation, individual therapy, and other programs at the Community Mental Health Center.
At the end of the sixth session, the measurement tools were applied again and the implementation phase of the research was ended.
After the Health Promotion Model and Motivational Interview-Based Health Protection and Improvement Program sessions applied to the experimental group were completed, the post-test was applied three and six months later, and the control group was followed-up by applying the post-test six weeks, three and six months later.
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahinur Betül ÇALIŞKAN, MSc
- Phone Number: +05070497185
- Email: mbcaliskan@hotmail.com
Study Contact Backup
- Name: Melike DİŞSİZ, Assoc. Prof.
- Phone Number: +05437995143
- Email: melike.dissiz@sbu.edu.tr
Study Locations
-
-
-
Istanbul, Turkey, 34668
- Recruiting
- Saglik Bilimleri Universitesi
-
Contact:
- Mahinur Betül Çalışkan, MsN
- Phone Number: +905070497185
- Email: mbcaliskan@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Who agrees to participate in the research himself or his guardian,
- Diagnosed with schizophrenia and other psychotic disorders for at least six months according to DSM-V diagnostic criteria,
- Registered with the Community Mental Health Center and coming regularly,
- Between the ages of 18-65,
- Who can read and write Turkish,
- Using antipsychotic medication for at least six months,
- Not in the "pre-thinking" stage in the change cycle stage,
- No skeletal, muscular, nervous system disease that prevents physical activity or healthy eating,
- They are patients without mental retardation, neurocognitive disorder, alcohol or substance abuse.
Exclusion Criteria:
- Failure of himself or his guardian to participate in the research,
- Without a diagnosis of schizophrenia and other psychotic disorders,
- Not coming regularly to the Community Mental Health Center,
- Under 18 years old and over 65 years old,
- Does not speak Turkish,
- Not using regular antipsychotic medication,
- In the "pre-thinking" stage of the cycle of change,
- Those with skeletal, muscular, nervous system diseases that prevent physical activity or healthy nutrition,
- They are patients with mental retardation, neurocognitive disorder, alcohol and substance addiction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
"Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program was applied to the intervention group
|
The Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program were applied to the experimental group, which consisted of 6 sessions and lasted an average of 60-120 minutes.
Sessions were held in the form of individual interviews due to the pandemic and social distance conditions.
|
NO_INTERVENTION: Control Group
Only data collection was carried out.
No attempt was made by the researcher during the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthy Life Style Behavior Scale II
Time Frame: 8 month
|
Scale; It consists of six sub-factors consisting of spiritual development, interpersonal relations, nutrition, physical activity, health responsibility and stress management and a total of 52 items.
The scale is a four-point Likert scale, scored as never: 1, sometimes: 2, often: 3, and regularly: 4.
|
8 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Improvement Profile
Time Frame: 8 month
|
The Health Promotion Profile was developed to diagnose the physical health conditions of individuals diagnosed with mental disorders.
This profile, which enables physical health risk assessment, is different for men and women.
The Health Promotion Profile consists of four sub-dimensions: measurements, blood tests, screenings and lifestyle.
|
8 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mahinur Betül ÇALIŞKAN, MSc, Istanbul Saglik Bilimleri University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 29, 2021
Primary Completion (ACTUAL)
October 28, 2021
Study Completion (ANTICIPATED)
April 1, 2022
Study Registration Dates
First Submitted
January 12, 2022
First Submitted That Met QC Criteria
January 12, 2022
First Posted (ACTUAL)
January 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SY200217B08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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