Motivational InterviewsNCT04941352
Motivational Interviewing in Patients With Schizophrenia
A study testing 6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up. in people with Motivational Interviews and Schizophrenia, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motivational Interviews, Schizophrenia
- What is being tested?
- 6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2019to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
Denizli, Kınıklı Kampus, 20160
About this study
Official title: 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).
Read the 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.
- Conditions
- Motivational Interviews, Schizophrenia
- Being tested
- 6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.
- Keywords
- Insight, Functional Recovery, Interpersonal Relations Theory, Motivational Interviews, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Study group | Experimental | Study group intervention consists 6-session Interpersonal Relations Theory-Based Motivational Interviews and 3-month follow-up. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline Functional Remission of General Schizophrenia score at 3 months
Secondary outcomes (1)
Number of health care uses
According to the patient's declaration, number of hospitalizations.
Measured: Change in the number of initial health care use in the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start17 Sep 2019
- Primary completion25 Feb 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewsStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled pre-post test design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrin Çunkuş, Pamukkale University
- Investigators
- Gülay Yiğitoğlu, PhD, Study director, Pamukkale UniversityNesrin Çunkuş, Msc, Principal investigator, Pamukkale UniversityAyşe Nur İnci Kenar, PhD, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941352
- Sponsor's protocol ID
- 60116787-020/50912
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be announced in a publication.
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.
PubMed 20595203Pinho 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.
PubMed 30454632Fernandes 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.
PubMed 29888541
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interpersonal Relations Theory-Based Motivational Interviews on Functional Recovery and Insight Levels of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04941352
- Acronym / sponsor ID
- 60116787-020/50912
- Conditions
- Motivational Interviews, Schizophrenia
- Keywords
- Insight, Functional Recovery, Interpersonal Relations Theory, Motivational Interviews, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled pre-post test design
| Arm | Type | Receives |
|---|---|---|
| Experimental: Study group | Experimental | Behavioral: 6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.Study group intervention consists 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental: Study group |
Primary outcome
Assessing the Three Components of Insight Score
Time frame: Change from baseline Assessing the Three Components of Insight score at 3 months
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
Time frame: Change from baseline Functional Remission of General Schizophrenia score at 3 months
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.
1 secondary outcome
Number of health care uses
Time frame: Change in the number of initial health care use in the 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- BackgroundTownsend 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 publication: PubMed 20595203Medalia 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 publicationPinho 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 publicationWorld Health Organisation (WHO) 2019. Schizophrenia. [Last accessed on 2021 May 6]. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia
- Results publication: PubMed 30454632Cho 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 publicationFernandes 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 publication: PubMed 29888541Ertem 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.
- Individual participant dataSharing planned: Yes. Study results will be announced in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Yiğitoğlu, PhD study director
Pamukkale University
Nesrin Çunkuş, Msc principal investigator
Pamukkale University
Ayşe Nur İnci Kenar, PhD study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up. in people with Motivational Interviews and Schizophrenia, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the Three Components of Insight Score (time frame: Change from baseline Assessing the Three Components of Insight score at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941352, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.