SchizophreniaNCT05259748
The Effect of Psychoeducation on Healthy Lifestyle Behaviors in Individuals With Schizophrenia
A study testing Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors in people with Schizophrenia, run by Hatay Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Definition: Schizophrenia is a chronic mental disorder that causes drastic changes in life quality and life functions, characterized by behavioural, cognitive and affective state deterioration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 2 Nov 2020
- 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
- Between the ages 18 and 65
- Being diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V)
- Being literate
- Not having education and language problem that can block the interview
- Being open to communication and cooperation
- Being in one of the three stages of the Transtheoretical Model: contemplation, preparation and action
Who cannot join
- Those who did not meet the inclusion criteria were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antakya Community Mental Health Center
Hatay, Antakya, 31000
About this study
Official title: The Effect of Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors in Individuals With Schizophrenia: Randomized Controlled Trial
Definition: Schizophrenia is a chronic mental disorder that causes drastic changes in life quality and life functions, characterized by behavioural, cognitive and affective state deterioration. Therefore, it is regarded as one of the most important health problems causing both personal and economic problems around the world. Unhealthy lifestyle behaviours in individuals with chronic mental disorders, like schizophrenia, are emphasized to play a big part in physical health problems. For individuals to develop a healthy lifestyle behaviour, it is necessary to primarily determine the lifestyle behaviours and then prevent the illnesses caused by the lifestyle and deaths linked to these illnesses. Current theory or models used to benefit from health programmes, prepared for the development of healthy lifestyle behaviours, should be deep-scaled. Theories and models are guides for systematic planning and decision-making. A well-defined model could contribute to the process of effective health improvement programmes for directive and content creation. One of the models mainly used to develop a behavioural change in health and explain how to obtain the most effective health behavioural change is the "Transtheoretical Model". Objective: The study was conducted with the pretest-posttest randomized controlled trial design to detect the effect of psychoeducation on a healthy lifestyle, based on the Transtheoretical Model in an individual with schizophrenia.
The Hypotheses of the Study Hypothesis 1: When the individuals with schizophrenia who received psychoeducation based on the Transtheoretical Model are compared to the ones that did not, they will show progress in behavioural change steps.
Read more
Hypothesis 2: When the individuals with schizophrenia who received psychoeducation based on the Transtheoretical Model are compared to the ones that did not, they will have higher final test results in the healthy lifestyle scale.
Methods: The data were collected from 82 participants, as 41 intervention and 41 control. The data were collected via personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II. 6-week psychoeducation, consisting of 6 modules, based on the Transtheoretical model, was applied to the intervention group. No interventions were applied to the control group. Pretests and posttests were applied to both groups.
Read the detailed description
This study is conducted in pretest-posttest randomized controlled experimental research type in a Community Mental Health Center in the south of Turkey. The population of the study are the individuals with schizophrenia who registered in a Community Mental Health Center and are under observation (N=230). The sample number is determined based on another similar study with power analysis. In the evaluation completed according to the healthy lifestyle behaviours score, the sample number needed to participate in the study was determined to be at least 42 (intervention group=21 - control group=21) in order for research results to have a meaningful effect.In order to reduce the selection bias in the determination of intervention and control groups, intervention and control groups were formed with a third person who did not have a direct role in the research from 1 to 82 using simple random sampling method. The data were collected from 82 individuals with schizophrenia, as 41 intervention and 41 control groups. The individuals with schizophrenia in the study and their families were informed according to the Helsinki Declaration and written and verbal approval were collected. The behavioural change identification form was applied to individuals with schizophrenia, who agreed to participate in the study, and their stage of the Transtheoretical Model was detected. The participants meeting the criteria in the participation stage (contemplation, preparation, action) were assigned to the intervention and control groups with the randomization. Pretests (personal information form, behavioural change identification form, Healthy Lifestyle Behaviours Scale II) were applied to the intervention and control groups before the psychoeducation. In addition to the rehabilitation activities conducted in the Community Mental Health Center, healthy lifestyle behaviours psychoeducation programme, based on the Transtheoretical Model, with 6 sessions (healthcare responsibility, nutrition, physical activity, spiritual development, interpersonal relationships, stress management) was applied to the intervention group for 6 weeks as three days in the weekdays and two sessions in a day. Psychoeducation was carried out by the researcher on the same day but within different time zones. Each psychoeducation session took 90-120 minutes with the breaks taken considering the participants' mood. After completing six sessions, the behavioural change identification form and Healthy Lifestyle Behaviours Scale II were applied to the intervention group again. On the other hand, the control group continued their rehabilitation practices prepared for themselves in the Community Mental Health Center. It was contacted with the control group three times, two face to face and one via phone. In the third and final meeting, when the intervention group's sessions are completed, the behavioural change identification form and Healthy Lifestyle Behaviours Scale II were applied again to the control group. All the participants remained in the study at the end of it. The study was completed with 41 individuals in the intervention group and 41 individuals in the control group. Statistical Package for the Social Sciences v23.0, which is a statistical analysis programme, was used to evaluate the findings of the study. It was benefited from descriptive statistics such as frequency, percentage, arithmetic average, standard deviation, minimum and maximum during data analysis. Parametric tests were used for the data analysis. The chi-squared test was used for relation analysis of two different categorized variables whereas the t-test was used while comparing averages of two independent groups. To determine the alteration of individuals' behavioural change stages before and after receiving psychoeducation, the McNemar test was used. Analysis of covariance (ANCOVA) while detecting the effect of the intervention study in the researches designed in the entrepreneurial pattern. In ANCOVA, to detect how big the effect of the independent variable on the dependent variable the eta squared (effect size) was calculated and the eta squared value (η2) was interpreted that it presents which parts of the change explain the total variant that the independent variable has on the dependent variable and it received a value. Eta squared is interpreted as 0,01 as the minor effect, 0,06 as medium effect and 0,14 as large effect. All test results were evaluated in terms of p<0.05 meaningfulness level
- Conditions
- Schizophrenia
- Being tested
- Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors
- Keywords
- Schizophrenia, Transtheoretical Model, Healthy Lifestyle, Behavioral Change, Mental Health and Psychiatric Nurse
- Medical subject headings
- Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle BehaviorsBehavioural
Healthy lifestyle behaviours psychoeducation programme, based on the Transtheoretical Model, with 6 sessions (healthcare responsibility, nutrition, physical activity, spiritual development, interpersonal relationships, stress management) was applied to the intervention group for 6 weeks as three days in the weekdays and two sessions in a day. Psychoeducation was carried out by the researcher on the same day but within different time zones. Each psychoeducation session took 90-120 minutes with the breaks taken considering the participants' mood. After completing six sessions, the behavioural change identification form and Healthy Lifestyle Behaviors Scale II were applied to the intervention group again.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | At the beginning, personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II were applied. 6-week psychoeducation, consisting of 6 modules, based on the Transtheoretical model, was applied to the intervention group. Finally, posttests were applied after the psychoeducation. Receives: Behavioral: Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors |
| control group | No intervention | At the beginning, personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II were applied. No interventions were applied to the control group. It was contacted with the control group three times, two face to face and one via phone. In the third and final meeting, when the intervention group's sessions are completed, posttests were applied again to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Behavioural Change Stage Identification Form
It was constructed by the researcher using the behavioral change stages of the transtheoretic model and to determine the behavioral stages of the participants in the areas of taking responsibility for their own health, nutrition, physical exercise, spiritual development, stress management and interpersonal relationships.. The structure of the model consists of stages as pre-contemplation, contemplation, preparation, action, maintenance and termination. These stages also describe the individuals' intention, attitude and behavioral change time, as well as their interests and motivations for change. The purpose of using this form is to determine which change stage the participants are in. Thus, it was aimed to provide each individual with the support they need at the stage they are in, to develop and to determine the effectiveness of the psychoeducation given by applying this form before and after the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale-change in health responsibility sub-dimension
Health responsibility is an individual's active sense of responsibility for their own well-being. It is to take care of his own health, to be informed about health, to seek professional help when necessary. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the health responsibility levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the health responsibility levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale-change in physical exercise sub-dimension
Physical exercise includes regular practice of light, moderate and heavy exercises. It is carried out in a planned way as a part of daily life. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the physical exercise levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the physical exercise levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale-change in nutrition sub-dimension
Nutrition determines the value of an individual in choosing, arranging and choosing meals. With this sub-scale of the healthy lifestyle behaviors scale, it was aimed to determine the nutrition levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the nutritional levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale-change in spiritual development sub-dimension
Spiritual development focuses on the development of inner resources. Growth can happen by relating and being transcended. Transcending provides inner peace, creating the possibility of providing opportunities for more new experiences outside of who we are and what we do. To relate is to be in relationship with the universe and to feel in harmony. Growth is working for life's purposes, maximizing the individual's power towards well-being. With this sub-scale of the healthy lifestyle behaviors scale, it is aimed to determine the spiritual development levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the spiritual development levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale-change in interpersonal relationships sub-dimension
Interpersonal relationships are relationships with others, requiring using communication to establish a meaningful relationship outside of causal requirements. Communication involves sharing thoughts and feelings through verbal and non-verbal messages. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the interpersonal relationship levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the interpersonal relationship levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Healthy Lifestyle Behaviours Scale- change in stress management sub-dimension
Stress management is the individual's ability to identify and activate physiological and psychological resources in order to reduce or effectively control tension. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the stress management levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the stress management levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
change in total of the Healthy Lifestyle Behaviours Scale points
The scale measures behaviors that develop health in relation to the healthy lifestyle of the individual. The scale has a total of 52 items and has 6 sub-factors. The subgroups are spiritual development, health responsibility, physical activity, nutrition, interpersonal relations and stress management. The general score of the scale provides a healthy lifestyle behavior score. The lowest score 52 for the entire scale is 52, the highest score is 208.It was aimed to compare and evaluate the efficacy of the healthy lifestyle behavior of the participants before and after the planned psychoeducation as 6 weeks.
Measured: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Apr 2019
- Primary completion18 Sep 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is conducted in pretest-posttest randomized controlled experimental research type.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatay Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sercan Mansuroglu, Hatay Training and Research Hospital
- Investigators
- Sercan Mansuroğlu, Dr., Principal investigator, Hatay Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259748
- Sponsor's protocol ID
- 10378149
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
Mansuroglu S, Kutlu FY. The Transtheoretical Model based psychoeducation's effect on healthy lifestyle behaviours in schizophrenia: A randomized controlled trial. Arch Psychiatr Nurs. 2022 Dec;41:51-61. doi: 10.1016/j.apnu.2022.07.018. Epub 2022 Jul 20.
PubMed 36428075
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors in Individuals With Schizophrenia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05259748
- Acronym / sponsor ID
- 10378149
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Transtheoretical Model, Healthy Lifestyle, Behavioral Change, Mental Health and Psychiatric Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hatay Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 2 Mar 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.
Definition: Schizophrenia is a chronic mental disorder that causes drastic changes in life quality and life functions, characterized by behavioural, cognitive and affective state deterioration. Therefore, it is regarded as one of the most important health problems causing both personal and economic problems around the world. Unhealthy lifestyle behaviours in individuals with chronic mental disorders, like schizophrenia, are emphasized to play a big part in physical health problems. For individuals to develop a healthy lifestyle behaviour, it is necessary to primarily determine the lifestyle behaviours and then prevent the illnesses caused by the lifestyle and deaths linked to these illnesses. Current theory or models used to benefit from health programmes, prepared for the development of healthy lifestyle behaviours, should be deep-scaled. Theories and models are guides for systematic planning and decision-making. A well-defined model could contribute to the process of effective health improvement programmes for directive and content creation. One of the models mainly used to develop a behavioural change in health and explain how to obtain the most effective health behavioural change is the "Transtheoretical Model". Objective: The study was conducted with the pretest-posttest randomized controlled trial design to detect the effect of psychoeducation on a healthy lifestyle, based on the Transtheoretical Model in an individual with schizophrenia.
The Hypotheses of the Study Hypothesis 1: When the individuals with schizophrenia who received psychoeducation based on the Transtheoretical Model are compared to the ones that did not, they will show progress in behavioural change steps.
Hypothesis 2: When the individuals with schizophrenia who received psychoeducation based on the Transtheoretical Model are compared to the ones that did not, they will have higher final test results in the healthy lifestyle scale.
Methods: The data were collected from 82 participants, as 41 intervention and 41 control. The data were collected via personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II. 6-week psychoeducation, consisting of 6 modules, based on the Transtheoretical model, was applied to the intervention group. No interventions were applied to the control group. Pretests and posttests were applied to both groups.
Detailed description
This study is conducted in pretest-posttest randomized controlled experimental research type in a Community Mental Health Center in the south of Turkey. The population of the study are the individuals with schizophrenia who registered in a Community Mental Health Center and are under observation (N=230). The sample number is determined based on another similar study with power analysis. In the evaluation completed according to the healthy lifestyle behaviours score, the sample number needed to participate in the study was determined to be at least 42 (intervention group=21 - control group=21) in order for research results to have a meaningful effect.In order to reduce the selection bias in the determination of intervention and control groups, intervention and control groups were formed with a third person who did not have a direct role in the research from 1 to 82 using simple random sampling method. The data were collected from 82 individuals with schizophrenia, as 41 intervention and 41 control groups. The individuals with schizophrenia in the study and their families were informed according to the Helsinki Declaration and written and verbal approval were collected. The behavioural change identification form was applied to individuals with schizophrenia, who agreed to participate in the study, and their stage of the Transtheoretical Model was detected. The participants meeting the criteria in the participation stage (contemplation, preparation, action) were assigned to the intervention and control groups with the randomization. Pretests (personal information form, behavioural change identification form, Healthy Lifestyle Behaviours Scale II) were applied to the intervention and control groups before the psychoeducation. In addition to the rehabilitation activities conducted in the Community Mental Health Center, healthy lifestyle behaviours psychoeducation programme, based on the Transtheoretical Model, with 6 sessions (healthcare responsibility, nutrition, physical activity, spiritual development, interpersonal relationships, stress management) was applied to the intervention group for 6 weeks as three days in the weekdays and two sessions in a day. Psychoeducation was carried out by the researcher on the same day but within different time zones. Each psychoeducation session took 90-120 minutes with the breaks taken considering the participants' mood. After completing six sessions, the behavioural change identification form and Healthy Lifestyle Behaviours Scale II were applied to the intervention group again. On the other hand, the control group continued their rehabilitation practices prepared for themselves in the Community Mental Health Center. It was contacted with the control group three times, two face to face and one via phone. In the third and final meeting, when the intervention group's sessions are completed, the behavioural change identification form and Healthy Lifestyle Behaviours Scale II were applied again to the control group. All the participants remained in the study at the end of it. The study was completed with 41 individuals in the intervention group and 41 individuals in the control group. Statistical Package for the Social Sciences v23.0, which is a statistical analysis programme, was used to evaluate the findings of the study. It was benefited from descriptive statistics such as frequency, percentage, arithmetic average, standard deviation, minimum and maximum during data analysis. Parametric tests were used for the data analysis. The chi-squared test was used for relation analysis of two different categorized variables whereas the t-test was used while comparing averages of two independent groups. To determine the alteration of individuals' behavioural change stages before and after receiving psychoeducation, the McNemar test was used. Analysis of covariance (ANCOVA) while detecting the effect of the intervention study in the researches designed in the entrepreneurial pattern. In ANCOVA, to detect how big the effect of the independent variable on the dependent variable the eta squared (effect size) was calculated and the eta squared value (η2) was interpreted that it presents which parts of the change explain the total variant that the independent variable has on the dependent variable and it received a value. Eta squared is interpreted as 0,01 as the minor effect, 0,06 as medium effect and 0,14 as large effect. All test results were evaluated in terms of p<0.05 meaningfulness level
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is conducted in pretest-posttest randomized controlled experimental research type.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle BehaviorsAt the beginning, personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II were applied. 6-week psychoeducation, consisting of 6 modules, based on the Transtheoretical model, was applied to the intervention group. Finally, posttests were applied after the psychoeducation. |
| control group | No intervention | –At the beginning, personal information form, behavioural change stage diagnosis form and healthy lifestyle scale II were applied. No interventions were applied to the control group. It was contacted with the control group three times, two face to face and one via phone. In the third and final meeting, when the intervention group's sessions are completed, posttests were applied again to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages 18 and 65
- Being diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V)
- Being literate
- Not having education and language problem that can block the interview
- Being open to communication and cooperation
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria were not included in the study.
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 |
|---|---|---|
| Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle BehaviorsHealthy lifestyle behaviours psychoeducation programme, based on the Transtheoretical Model, with 6 sessions (healthcare responsibility, nutrition, physical activity, spiritual development, interpersonal relationships, stress management) was applied to the intervention group for 6 weeks as three days in the weekdays and two sessions in a day. Psychoeducation was carried out by the researcher on the same day but within different time zones. Each psychoeducation session took 90-120 minutes with the breaks taken considering the participants' mood. After completing six sessions, the behavioural change identification form and Healthy Lifestyle Behaviors Scale II were applied to the intervention group again. | Behavioural | intervention group |
Primary outcome
Change in the Behavioural Change Stage Identification Form
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
It was constructed by the researcher using the behavioral change stages of the transtheoretic model and to determine the behavioral stages of the participants in the areas of taking responsibility for their own health, nutrition, physical exercise, spiritual development, stress management and interpersonal relationships.. The structure of the model consists of stages as pre-contemplation, contemplation, preparation, action, maintenance and termination. These stages also describe the individuals' intention, attitude and behavioral change time, as well as their interests and motivations for change. The purpose of using this form is to determine which change stage the participants are in. Thus, it was aimed to provide each individual with the support they need at the stage they are in, to develop and to determine the effectiveness of the psychoeducation given by applying this form before and after the intervention.
Healthy Lifestyle Behaviours Scale-change in health responsibility sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Health responsibility is an individual's active sense of responsibility for their own well-being. It is to take care of his own health, to be informed about health, to seek professional help when necessary. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the health responsibility levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the health responsibility levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Healthy Lifestyle Behaviours Scale-change in physical exercise sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Physical exercise includes regular practice of light, moderate and heavy exercises. It is carried out in a planned way as a part of daily life. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the physical exercise levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the physical exercise levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Healthy Lifestyle Behaviours Scale-change in nutrition sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Nutrition determines the value of an individual in choosing, arranging and choosing meals. With this sub-scale of the healthy lifestyle behaviors scale, it was aimed to determine the nutrition levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the nutritional levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Healthy Lifestyle Behaviours Scale-change in spiritual development sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Spiritual development focuses on the development of inner resources. Growth can happen by relating and being transcended. Transcending provides inner peace, creating the possibility of providing opportunities for more new experiences outside of who we are and what we do. To relate is to be in relationship with the universe and to feel in harmony. Growth is working for life's purposes, maximizing the individual's power towards well-being. With this sub-scale of the healthy lifestyle behaviors scale, it is aimed to determine the spiritual development levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the spiritual development levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Healthy Lifestyle Behaviours Scale-change in interpersonal relationships sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Interpersonal relationships are relationships with others, requiring using communication to establish a meaningful relationship outside of causal requirements. Communication involves sharing thoughts and feelings through verbal and non-verbal messages. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the interpersonal relationship levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the interpersonal relationship levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
Healthy Lifestyle Behaviours Scale- change in stress management sub-dimension
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
Stress management is the individual's ability to identify and activate physiological and psychological resources in order to reduce or effectively control tension. With this subscale of the healthy lifestyle behaviors scale, it was aimed to determine the stress management levels of the participants. With the psychoeducation planned for 6 weeks, it was aimed to determine and compare the stress management levels of the participants before and after the intervention and to evaluate the effectiveness of the intervention.
change in total of the Healthy Lifestyle Behaviours Scale points
Time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.
The scale measures behaviors that develop health in relation to the healthy lifestyle of the individual. The scale has a total of 52 items and has 6 sub-factors. The subgroups are spiritual development, health responsibility, physical activity, nutrition, interpersonal relations and stress management. The general score of the scale provides a healthy lifestyle behavior score. The lowest score 52 for the entire scale is 52, the highest score is 208.It was aimed to compare and evaluate the efficacy of the healthy lifestyle behavior of the participants before and after the planned psychoeducation as 6 weeks.
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 2 Mar 2022.
- Derived from this study: PubMed 36428075Mansuroglu S, Kutlu FY. The Transtheoretical Model based psychoeducation's effect on healthy lifestyle behaviours in schizophrenia: A randomized controlled trial. Arch Psychiatr Nurs. 2022 Dec;41:51-61. doi: 10.1016/j.apnu.2022.07.018. Epub 2022 Jul 20.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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Mental Health Promotion
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.
Sercan Mansuroğlu, Dr. principal investigator
Hatay Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation Based on the Transtheoretical Model on Healthy Lifestyle Behaviors in people with Schizophrenia, run by Hatay Training and Research Hospital 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 6 inclusion and 1 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 2 Mar 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?
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?
Change in the Behavioural Change Stage Identification Form (time frame: It was applied as a pre-test before the intervention and as a post-test 6 weeks after the intervention, within 1 week, and the change was observed.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259748, which also lists 1 linked publication.
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 2 Mar 2022.