- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941352
Motivational Interviewing in Patients With Schizophrenia
The Effect of Interpersonal Relations Theory-Based Motivational Interviews on Functional Recovery and Insight Levels of Patients With Schizophrenia
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).
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kınıklı Kampus
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Denizli, Kınıklı Kampus, Turkey, 20160
- Pamukkale University Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental: Study group
Study group intervention consists 6-session Interpersonal Relations Theory-Based Motivational Interviews and 3-month follow-up.
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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.
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No Intervention: No Intervention: Control group
Control group receives general care and the training booklet at the end of the study.
Also includes 3-month follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the Three Components of Insight Score
Time Frame: Change from baseline Assessing the Three Components of Insight score at 3 months
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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.
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Change from baseline Assessing the Three Components of Insight score at 3 months
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Functional Remission of General Schizophrenia Score
Time Frame: Change from baseline Functional Remission of General Schizophrenia score at 3 months
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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.
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Change from baseline Functional Remission of General Schizophrenia score at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of health care uses
Time Frame: Change in the number of initial health care use in the 3rd month
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According to the patient's declaration, number of hospitalizations.
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Change in the number of initial health care use in the 3rd month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gülay Yiğitoğlu, PhD, Pamukkale University
- Principal Investigator: Nesrin Çunkuş, Msc, Pamukkale University
- Study Chair: Ayşe Nur İnci Kenar, PhD, Pamukkale University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- World Health Organisation (WHO) 2019. Schizophrenia. [Last accessed on 2021 May 6]. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/50912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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