NCT04941352

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 17, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

June 22, 2021

Last Update Submit

June 25, 2021

Conditions

Keywords

InsightFunctional RecoveryInterpersonal Relations TheoryMotivational InterviewsSchizophrenia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Number of health care uses

    Change in the number of initial health care use in the 3rd month

Study Arms (2)

Experimental: Study group

EXPERIMENTAL

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

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

No Intervention: Control group

NO INTERVENTION

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

Interventions

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.

Experimental: Study group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Denizli, Kınıklı Kampus, 20160, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    BACKGROUND
  • 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.

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

    RESULT
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Gülay Yiğitoğlu, PhD

    Pamukkale University

    STUDY DIRECTOR
  • Nesrin Çunkuş, Msc

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Ayşe Nur İnci Kenar, PhD

    Pamukkale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and caregivers were not informed about intervention content and measurements.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled pre-post test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 28, 2021

Study Start

September 17, 2019

Primary Completion

February 25, 2021

Study Completion

June 11, 2021

Last Updated

June 28, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Study results will be announced in a publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Findings can be shared after the study has been published.
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.

Locations