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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04941352
Other study ID # 60116787-020/50912
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2019
Est. completion date June 11, 2021

Study information

Verified date June 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 11, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.
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.

Locations

Country Name City State
Turkey Pamukkale University Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing Denizli Kinikli Kampus

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

Ertem MY, Duman ZÇ. 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. — View 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.

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. — View 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.

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.

World Health Organisation (WHO) 2019. Schizophrenia. [Last accessed on 2021 May 6]. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline Assessing the Three Components of Insight score at 3 months
Primary 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. Change from baseline Functional Remission of General Schizophrenia score at 3 months
Secondary Number of health care uses According to the patient's declaration, number of hospitalizations. Change in the number of initial health care use in the 3rd month
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