NCT05208021

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

January 12, 2022

Last Update Submit

January 26, 2022

Conditions

Keywords

healthy lifestyleschizophreniamotivational interviewingpsychiatric nursing

Outcome Measures

Primary Outcomes (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.

    8 month

Secondary Outcomes (1)

  • Health Improvement Profile

    8 month

Study Arms (2)

Intervention group

EXPERIMENTAL

"Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program was applied to the intervention group

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

Interventions

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mahinur Betül ÇALIŞKAN, MSc

    Istanbul Saglik Bilimleri University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahinur Betül ÇALIŞKAN, MSc

CONTACT

Melike DİŞSİZ, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Experimental: Intervention group "Health Promotion Model and the Motivational Interview-Based Health Protection and Promotion Program was applied to the intervention group No Intervention: Control Group Only data collection was carried out. No attempt was made by the researcher during the study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in nursing departman

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

March 29, 2021

Primary Completion

October 28, 2021

Study Completion

April 1, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations