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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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)
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.

Mahinur Betül ÇALIŞKAN, MSc contact

+05070497185

mbcaliskan@hotmail.com

Melike DİŞSİZ, Assoc. Prof. contact

+05437995143

melike.dissiz@sbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Saglik Bilimleri Universitesi

    Istanbul, 34668

    Mahinur Betül Çalışkan, MsN, +905070497185, mbcaliskan@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT05208021
Study groupRoleWhat they receive
Intervention groupExperimental"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 GroupNo interventionOnly 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.

  1. 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)
  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.

  1. First posted26 Jan 2022
  2. Study start29 Mar 2021
  3. Primary completion28 Oct 2021
  4. Study completionApr 2022 (estimated)

Resources

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)
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

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.

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