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Motivational Interviewing in Patients With Schizophrenia

Primary Purpose

Motivational Interviews, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Motivational Interviews focused on measuring Insight, Functional Recovery, Interpersonal Relations Theory, Motivational Interviews, Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To be at least primary school graduate,
  • Living in the city center of Denizli,
  • Being open to communication and cooperation.
  • Being between the ages of 18-65,
  • Being in remission (period without psychotic exacerbation),
  • To have a diagnosis of schizophrenia according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria.

Exclusion Criteria:

  • Being under the age of 18 and over the age of 65,
  • Being illiterate in Turkish,
  • Having Mental Retardation,
  • Being diagnosed with a mental illness other than schizophrenia according to the DSM-5 diagnostic criteria,
  • Being in a psychotic attack period.

Sites / Locations

  • Pamukkale University Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Study group

No Intervention: Control group

Arm Description

Study group intervention consists 6-session Interpersonal Relations Theory-Based Motivational Interviews and 3-month follow-up.

Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up.

Outcomes

Primary Outcome Measures

Assessing the Three Components of Insight Score
Scales were filled in by interviewing each participant. The scale consists of 8 questions. In the first 7 questions, each item is evaluated as 0-2. The highest total score of the first seven questions is 14. The eighth question is presented as an appendix. It is left to the researcher to ask this question. The highest total score with this question is 18. Increased score indicates an increase in insight.
Functional Remission of General Schizophrenia Score
Scales were filled in by interviewing each participant. Scoring is done between 1-5 points. The maximum score that can be obtained from the scale is 95, and the minimum score is 19. Increased score indicates an increase in general functionality.

Secondary Outcome Measures

Number of health care uses
According to the patient's declaration, number of hospitalizations.

Full Information

First Posted
June 22, 2021
Last Updated
June 25, 2021
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04941352
Brief Title
Motivational Interviewing in Patients With Schizophrenia
Official Title
The Effect of Interpersonal Relations Theory-Based Motivational Interviews on Functional Recovery and Insight Levels of Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction: A poor therapeutic relationship, low insight and lack of motivation are associated with poor adjustment (to symptoms, treatment, and environment) in patients with schizophrenia. In order to achieve better compliance and results, the therapeutic relationship and insight should be developed by increasing the motivation of individuals. Purpose: This study examines the effect of Interpersonal Relations Theory-Based motivational interviews on functional recovery and insight levels of patients with schizophrenia. Methods: This single-blind, randomized controlled study used the simple randomization method and employed a pretest-posttest control group design, which is an experimental research design. The study was conducted at Pamukkale University, Health Research and Application Center, Habib Kızıltaş Psychiatric Hospital from November 2019 to June 2020 and included 40 individuals (20 in the experimental and 20 in the control groups). Study data were collected using a personal information form, the Functional Remission of General Schizophrenia Scale (FROGS) and the Scale for Assessing the Three Components of Insight (SAI). The researchers carried out a 6-session Interpersonal Relations Theory-based motivational interview with the participants in the experimental group. No intervention was made to the control group. The data were analyzed on the basis of pre-intervention, post-intervention and 3 months after the intervention (follow-up).
Detailed Description
Schizophrenia is a severe mental illness that causes problems in the thoughts, feelings, and behaviors of the individual, impairs the ability to evaluate reality, has a unique world and keeps the individual away from social life, causes difficulties in his family and social environment, relapses, and is a progressive, severe mental illness when regular treatment is not applied. It is reported that individuals diagnosed with schizophrenia have poor insight into how they evaluate the symptoms of the disease and what they expect from treatment. One of the problems of individuals diagnosed with schizophrenia is lack of motivation. It is stated that this may be caused by the dopaminergic system. This situation can cause individuals to have difficulties in social life. In this context, it is important to evaluate motivational processes in the treatment of schizophrenia and to plan and implement initiatives that will increase motivation. A poor therapeutic relationship, low insight and lack of motivation are associated with poor adjustment (to symptoms, treatment, and environment) in patients with schizophrenia. In order to achieve better compliance and results, the therapeutic relationship and insight should be developed by increasing the motivation of individuals. Nurses need to establish a therapeutic relationship in order for the nursing care to produce effective results in the recovery process of these patients. In this study, it is thought that Interpersonal Relations-Based Motivational Interviewing can be effective in increasing the symptom management, social-occupational functionality, adherence to treatment, daily life skills and insight levels of patients with schizophrenia, and may shed light and guide psychiatric nursing interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivational Interviews, Schizophrenia
Keywords
Insight, Functional Recovery, Interpersonal Relations Theory, Motivational Interviews, Schizophrenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled pre-post test design
Masking
ParticipantCare Provider
Masking Description
Participants and caregivers were not informed about intervention content and measurements.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Study group
Arm Type
Experimental
Arm Description
Study group intervention consists 6-session Interpersonal Relations Theory-Based Motivational Interviews and 3-month follow-up.
Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm Description
Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.
Intervention Description
6-session Interpersonal Relations Theory-based Motivational Interviews were applied to the individuals in the study group. All sessions were conducted face-to-face in the form of individual interviews. Each interview lasted an average of 30-40 minutes. With this intervention, it was aimed to increase treatment cooperation and motivation in individuals with schizophrenia, to increase insight, to improve adherence to treatment, daily living skills and social functionality.Study data were collected using a personal information form, the Functional Remission of General Schizophrenia Scale (FROGS) and the Scale for Assessing the Three Components of Insight (SAI). The data were analyzed on the basis of pre-intervention, post-intervention and 3 months after the intervention.
Primary Outcome Measure Information:
Title
Assessing the Three Components of Insight Score
Description
Scales were filled in by interviewing each participant. The scale consists of 8 questions. In the first 7 questions, each item is evaluated as 0-2. The highest total score of the first seven questions is 14. The eighth question is presented as an appendix. It is left to the researcher to ask this question. The highest total score with this question is 18. Increased score indicates an increase in insight.
Time Frame
Change from baseline Assessing the Three Components of Insight score at 3 months
Title
Functional Remission of General Schizophrenia Score
Description
Scales were filled in by interviewing each participant. Scoring is done between 1-5 points. The maximum score that can be obtained from the scale is 95, and the minimum score is 19. Increased score indicates an increase in general functionality.
Time Frame
Change from baseline Functional Remission of General Schizophrenia score at 3 months
Secondary Outcome Measure Information:
Title
Number of health care uses
Description
According to the patient's declaration, number of hospitalizations.
Time Frame
Change in the number of initial health care use in the 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be at least primary school graduate, Living in the city center of Denizli, Being open to communication and cooperation. Being between the ages of 18-65, Being in remission (period without psychotic exacerbation), To have a diagnosis of schizophrenia according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria. Exclusion Criteria: Being under the age of 18 and over the age of 65, Being illiterate in Turkish, Having Mental Retardation, Being diagnosed with a mental illness other than schizophrenia according to the DSM-5 diagnostic criteria, Being in a psychotic attack period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülay Yiğitoğlu, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nesrin Çunkuş, Msc
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayşe Nur İnci Kenar, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
City
Denizli
State/Province
Kınıklı Kampus
ZIP/Postal Code
20160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be announced in a publication.
IPD Sharing Time Frame
Findings can be shared after the study has been published.
IPD Sharing Access Criteria
The sociodemographic and disease-related characteristics of the participants, the pre-post-test and follow-up findings including the answers to the research questions and statistical analyzes will be shared.
Citations:
Citation
Townsend MC, Morgan KI. Schizoprenia spectrum and other Psychotic disorders. Psychiatric mental health nursing: Concepts of care in evidence-based practice. F. A. Davis Company, Philadelphia, 2017, s. 456-489.
Results Reference
background
PubMed Identifier
20595203
Citation
Medalia A, Brekke J. In search of a theoretical structure for understanding motivation in schizophrenia. Schizophr Bull. 2010 Sep;36(5):912-8. doi: 10.1093/schbul/sbq073. Epub 2010 Jun 30.
Results Reference
result
Citation
Pinho LGD, Pereira A, Chaves C. Nursing interventions in schizophrenia: The importance of therapeutic relationship. Nurse Care Open Acces J 2017; 3 (6): 331-333.
Results Reference
result
Citation
World Health Organisation (WHO) 2019. Schizophrenia. [Last accessed on 2021 May 6]. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia
Results Reference
result
PubMed Identifier
30454632
Citation
Cho JM, Lee K. Effects of motivation interviewing using a group art therapy program on negative symptoms of schizophrenia. Arch Psychiatr Nurs. 2018 Dec;32(6):878-884. doi: 10.1016/j.apnu.2018.07.002. Epub 2018 Jul 19.
Results Reference
result
Citation
Fernandes MA, de Almeida JS, de Oliveira ÉKC, Sousa KHJF. Nursing process based on Peplau interpersonal relationship theory applied to schizophrenia. REUFPI 2018; 7 (3): 42-47.
Results Reference
result
PubMed Identifier
29888541
Citation
Ertem MY, Duman ZC. The effect of motivational interviews on treatment adherence and insight levels of patients with schizophrenia: A randomized controlled study. Perspect Psychiatr Care. 2019 Jan;55(1):75-86. doi: 10.1111/ppc.12301. Epub 2018 Jun 11.
Results Reference
result

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Motivational Interviewing in Patients With Schizophrenia

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