SchizophreniaNCT05208021
The Effect of Psychoeducation Program on Healthy Living Behaviors
A study testing Intervention group (Motivational Interviewing) in people with Schizophrenia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Intervention group (Motivational Interviewing)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2021to Apr 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri Universitesi
Istanbul, 34668
Mahinur Betül Çalışkan, MsN, +905070497185, mbcaliskan@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Intervention group (Motivational Interviewing)
- Keywords
- healthy lifestyle, schizophrenia, motivational interviewing, psychiatric nursing
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group (Motivational Interviewing)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | "Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program was applied to the intervention group Receives: Behavioral: Intervention group (Motivational Interviewing) |
| Control Group | No intervention | Only data collection was carried out. No attempt was made by the researcher during the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Life Style Behavior Scale II
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.
Measured: 8 month
Secondary outcomes (1)
Health Improvement Profile
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.
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start29 Mar 2021
- Primary completion28 Oct 2021
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahinur Betül Çalışkan, Saglik Bilimleri Universitesi
- Investigators
- Mahinur Betül ÇALIŞKAN, MSc, Principal investigator, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208021
- Sponsor's protocol ID
- SY200217B08
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individual Psychoeducation Program Based on the Health Promotion Model on the Healthy Living Behaviors of Individuals With Schizophrenia
- ClinicalTrials.gov ID
- NCT05208021
- Acronym / sponsor ID
- SY200217B08
- Conditions
- Schizophrenia
- Keywords
- healthy lifestyle, schizophrenia, motivational interviewing, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 26 Jan 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention group (Motivational Interviewing)"Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program was applied to the intervention group |
| Control Group | No intervention | –Only data collection was carried out. No attempt was made by the researcher during the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Intervention group (Motivational Interviewing)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. | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Health Improvement Profile
Time frame: 8 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Mahinur Betül ÇALIŞKAN, MSc principal investigator
Istanbul Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group (Motivational Interviewing) in people with Schizophrenia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahinur Betül ÇALIŞKAN, MSc (+05070497185, mbcaliskan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Life Style Behavior Scale II (time frame: 8 month). 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 10 Feb 2022.