NCT05259748

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

November 29, 2021

Last Update Submit

February 15, 2022

Conditions

Keywords

SchizophreniaTranstheoretical ModelHealthy LifestyleBehavioral ChangeMental Health and Psychiatric Nurse

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

Study Arms (2)

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.

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.

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antakya Community Mental Health Center

Hatay, Antakya, 31000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaPsychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Sercan Mansuroğlu, Dr.

    Hatay Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The control group included in the study was not informed about the planned interventions to the experimental group before the study. Necessary information about the intervention study performed on the experimental group was given to the control group after the study was completed.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: This study is conducted in pretest-posttest randomized controlled experimental research type.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2021

First Posted

March 2, 2022

Study Start

April 1, 2019

Primary Completion

September 18, 2020

Study Completion

November 2, 2020

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available.

Locations