SchizophreniaNCT06820580
The Effect of Salutogenic-based Interviewing on Subjective Recovery and Quality of Life in Schizophrenia
A study testing Salutogenic Approach Based Interview in people with Schizophrenia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Schizophrenia is an inherited, complex, multidimensional syndrome with varying degrees of psychotic, negative, cognitive, mood and motor symptoms. Schizophrenia is a serious public health problem that causes significant losses in the lives of individuals due to both its occurrence at a young age and its prevalence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Salutogenic Approach Based Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- The participant is in the recovery (remission) period
- Being diagnosed with schizophrenia
- Being suitable for group work
Who cannot join
- The participant experienced an exacerbation (relapse) period
- Presence of hearing and comprehension problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Elazığ Community Mental Health Center
Elâzığ, Province, 23000
Şeyda Erçel, MSc, +90 539 493 37 90, seydaercel23@gmail.com
About this study
Official title: The Effect of Salutogenic Approach Based Interview on Subjective Recovery and Quality of Life in Individuals With Schizophrenia
Schizophrenia is an inherited, complex, multidimensional syndrome with varying degrees of psychotic, negative, cognitive, mood and motor symptoms. Schizophrenia is a serious public health problem that causes significant losses in the lives of individuals due to both its occurrence at a young age and its prevalence. Ranked by the World Health Organization as one of the top ten diseases contributing to the global burden of disease, it is among the most disabling and economically disastrous medical disorders. The boundaries of schizophrenia remain unclear, indicating a lack of categorical cohesion and the need to reconceptualize it as a broader, multidimensional and/or spectrum construct.
With the discovery of antipsychotic drugs, the symptoms of the disease were alleviated, the level of severity decreased and the length of hospitalization was shortened. However, this led to repeated hospitalizations of patients with chronic course and a revolving door effect occurred. Drug treatment has a limited effect on readjustment to society, improving social relations and increasing self-care activities in individuals with chronic mental illness. Therefore, it is important to support drug treatment with social support programs and various psychosocial approaches. In the past, pathogenic approaches focusing on problems and risk factors have been adopted to promote and maintain health. The salutogenic model developed by medical sociologist Aaron Antonovsky (1987) focuses on the causes of health rather than the factors that cause disease. This model is concerned with the relationship between how people approach stressful situations (such as mental and chronic health conditions and their consequences) and their individual ability to self-manage and cope with these situations. The model is a medical approach that focuses on the causes of health rather than the factors that cause disease.
This study was planned to evaluate the effect of salutogenic approach-based interviewing on subjective recovery and quality of life in individuals diagnosed with schizophrenia.
Read the detailed description
Salutogenesis theory focuses on what contributes to the development of good health and contrasts with pathogenesis explaining disease. The most important question for the salutogenic orientation is how a person identifies and utilizes different resources and thus how health promotion can be supported. It focuses on the creation and maintenance of good health rather than looking for the cause of specific diseases. This is in contrast to the traditional pathogenic model, which focuses on risk factors that play a role in disease occurrence.
The similarity between the core principle of the salutogenic model and the professional purpose of psychiatric nursing is striking. Psychiatric nursing supports the protection and promotion of community mental health, the rehabilitation of disorders and the regaining of the ability to cope with the experiences of suffering and to find meaning in life. Therefore, the model is suitable for many practice areas of psychiatric nurses.
The increasing number of people living with mental health problems in society for many years focuses on the need for recovery from a coping and mental health promotion perspective. The value of salutogenic theory is that it emphasizes coping and health promotion. Although there are numerous empirical applications of salutogenic theory in the field of public health, reviews of salutogenic-based interventions and their impact on population health are limited. Through the salutogenic method, examining deep challenges can provide opportunities to understand how individuals cope during crises and suggest methods to improve the health of the general population. As nursing education and intervention, it is important in terms of emphasizing the need for health promotion and ultimately promoting normal physical and psychological health.
The motto of the Mental Health Action Plan for 2021-2023 is stated as "Implementing an integrated community-based mental health service model in mental health services, monitoring, protecting and improving the mental health of individuals". Subjective recovery is a personally perceived improvement that includes other factors beyond clinical recovery. These factors focus on areas of personal development such as empowerment, having a sense of hope, having confidence in the future, redefining oneself, overcoming stigmatization, establishing supportive relationships, taking responsibility, giving meaning to life and leading a fulfilling life. Subjective well-being and quality of life are increasingly recognized as important treatment outcomes in patients with schizophrenia. Schizophrenia, which usually lasts a lifetime, is a disorder that causes significant problems in quality of life and functioning. Factors such as physical health, adaptability, well-being, economic status and social interaction are among the components of quality of life.
Therefore, this study was planned to evaluate the effect of salutogenic approach-based interviewing on subjective recovery and quality of life in individuals diagnosed with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Salutogenic Approach Based Interview
- Keywords
- Schizophrenia, Salutogenesis, Subjective Recovery, Quality of Life
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salutogenic Approach Based InterviewOther
Salutogenic Approach Based Interviewing Program consists of 8 sessions. The interview will be conducted for four weeks and on two specific days of the week. Interviews will be conducted in groups of 6-8 people. The interview will last 30-40 minutes on average.
| Study group | Role | What they receive |
|---|---|---|
| Salutogenic Approach Based Interview Group | Experimental | Participants will be offered an 8-session Salutogenic Approach Based Interview Program two days a week. Receives: Other: Salutogenic Approach Based Interview |
| Control group | No intervention | There will be no intervention interview. They will continue their normal routines and treatments at the community mental health center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Recovery Assessment Scale
It is a 17-item Likert-type self-report scale. Each item is scored from 1 to 5. Higher scores indicate that the individual perceives himself/herself as more recovered. The scale has no sub-dimensions and is evaluated as a single factor. Cronbach's alpha coefficient of the scale was found to be 0.987.
Measured: From immediately before the interview began to 4 weeks after the interview.
Secondary outcomes (1)
Quality of Life Scale for Schizophrenia
The scale, which is administered in a semi-structured interview and assessed by the interviewer, is designed to assess the quality of life of schizophrenia patients receiving maintenance treatment. The scale provides information about symptoms and functioning over the previous four weeks. It consists of 21 questions and four sub-dimensions: interpersonal relationships (questions 1-8), occupational role (questions 9-12), mental symptoms (questions 13-17 and 20-21), and daily use and activities (questions 18-19). Each item consists of three parts. In the first part, a brief description is given to help the interviewer understand and focus on the parameter to be assessed, in the second part, a few sample questions are given to help the interviewer examine the patient, and in the third part, a 7-point Likert-type scale is given to make the assessment. The Cronbach Alpha reliability coefficient of the scale was found to be 0.80.
Measured: From immediately before the interview began to 4 weeks after the interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion26 Oct 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled study design will be used. It is planned to include 30 individuals in the experimental group and 30 individuals in the control group by randomization method (using the software at http://www.randomizer.org). Participants will be divided into two groups: Experimental group Control group Individuals in the experimental group will be subjected to a four-week training program and assessments will be made twice, before and after the training. In the control group, no training will be given and the assessments will be conducted twice, four weeks apart.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda Erçel, Ataturk University
- Investigators
- Şeyda Erçel, MSc, Principal investigator, Ataturk UniversitySibel Asi Karakaş, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820580
- Sponsor's protocol ID
- AU-SBF-ŞE-01
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salutogenic Approach Based Interview on Subjective Recovery and Quality of Life in Individuals With Schizophrenia
- ClinicalTrials.gov ID
- NCT06820580
- Acronym / sponsor ID
- AU-SBF-ŞE-01
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Salutogenesis, Subjective Recovery, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 26 Oct 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
Schizophrenia is an inherited, complex, multidimensional syndrome with varying degrees of psychotic, negative, cognitive, mood and motor symptoms. Schizophrenia is a serious public health problem that causes significant losses in the lives of individuals due to both its occurrence at a young age and its prevalence. Ranked by the World Health Organization as one of the top ten diseases contributing to the global burden of disease, it is among the most disabling and economically disastrous medical disorders. The boundaries of schizophrenia remain unclear, indicating a lack of categorical cohesion and the need to reconceptualize it as a broader, multidimensional and/or spectrum construct.
With the discovery of antipsychotic drugs, the symptoms of the disease were alleviated, the level of severity decreased and the length of hospitalization was shortened. However, this led to repeated hospitalizations of patients with chronic course and a revolving door effect occurred. Drug treatment has a limited effect on readjustment to society, improving social relations and increasing self-care activities in individuals with chronic mental illness. Therefore, it is important to support drug treatment with social support programs and various psychosocial approaches. In the past, pathogenic approaches focusing on problems and risk factors have been adopted to promote and maintain health. The salutogenic model developed by medical sociologist Aaron Antonovsky (1987) focuses on the causes of health rather than the factors that cause disease. This model is concerned with the relationship between how people approach stressful situations (such as mental and chronic health conditions and their consequences) and their individual ability to self-manage and cope with these situations. The model is a medical approach that focuses on the causes of health rather than the factors that cause disease.
This study was planned to evaluate the effect of salutogenic approach-based interviewing on subjective recovery and quality of life in individuals diagnosed with schizophrenia.
Detailed description
Salutogenesis theory focuses on what contributes to the development of good health and contrasts with pathogenesis explaining disease. The most important question for the salutogenic orientation is how a person identifies and utilizes different resources and thus how health promotion can be supported. It focuses on the creation and maintenance of good health rather than looking for the cause of specific diseases. This is in contrast to the traditional pathogenic model, which focuses on risk factors that play a role in disease occurrence.
The similarity between the core principle of the salutogenic model and the professional purpose of psychiatric nursing is striking. Psychiatric nursing supports the protection and promotion of community mental health, the rehabilitation of disorders and the regaining of the ability to cope with the experiences of suffering and to find meaning in life. Therefore, the model is suitable for many practice areas of psychiatric nurses.
The increasing number of people living with mental health problems in society for many years focuses on the need for recovery from a coping and mental health promotion perspective. The value of salutogenic theory is that it emphasizes coping and health promotion. Although there are numerous empirical applications of salutogenic theory in the field of public health, reviews of salutogenic-based interventions and their impact on population health are limited. Through the salutogenic method, examining deep challenges can provide opportunities to understand how individuals cope during crises and suggest methods to improve the health of the general population. As nursing education and intervention, it is important in terms of emphasizing the need for health promotion and ultimately promoting normal physical and psychological health.
The motto of the Mental Health Action Plan for 2021-2023 is stated as "Implementing an integrated community-based mental health service model in mental health services, monitoring, protecting and improving the mental health of individuals". Subjective recovery is a personally perceived improvement that includes other factors beyond clinical recovery. These factors focus on areas of personal development such as empowerment, having a sense of hope, having confidence in the future, redefining oneself, overcoming stigmatization, establishing supportive relationships, taking responsibility, giving meaning to life and leading a fulfilling life. Subjective well-being and quality of life are increasingly recognized as important treatment outcomes in patients with schizophrenia. Schizophrenia, which usually lasts a lifetime, is a disorder that causes significant problems in quality of life and functioning. Factors such as physical health, adaptability, well-being, economic status and social interaction are among the components of quality of life.
Therefore, this study was planned to evaluate the effect of salutogenic approach-based interviewing on subjective recovery and quality of life in individuals diagnosed with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled study design will be used. It is planned to include 30 individuals in the experimental group and 30 individuals in the control group by randomization method (using the software at http://www.randomizer.org). Participants will be divided into two groups: Experimental group Control group Individuals in the experimental group will be subjected to a four-week training program and assessments will be made twice, before and after the training. In the control group, no training will be given and the assessments will be conducted twice, four weeks apart.
| Arm | Type | Receives |
|---|---|---|
| Salutogenic Approach Based Interview Group | Experimental | Other: Salutogenic Approach Based InterviewParticipants will be offered an 8-session Salutogenic Approach Based Interview Program two days a week. |
| Control group | No intervention | –There will be no intervention interview. They will continue their normal routines and treatments at the community mental health center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- The participant is in the recovery (remission) period
- Being diagnosed with schizophrenia
- Being suitable for group work
Key exclusion criteria (2 listed)
- The participant experienced an exacerbation (relapse) period
- Presence of hearing and comprehension problems
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 |
|---|---|---|
| Salutogenic Approach Based InterviewSalutogenic Approach Based Interviewing Program consists of 8 sessions. The interview will be conducted for four weeks and on two specific days of the week. Interviews will be conducted in groups of 6-8 people. The interview will last 30-40 minutes on average. | Other | Salutogenic Approach Based Interview Group |
Primary outcome
Subjective Recovery Assessment Scale
Time frame: From immediately before the interview began to 4 weeks after the interview.
It is a 17-item Likert-type self-report scale. Each item is scored from 1 to 5. Higher scores indicate that the individual perceives himself/herself as more recovered. The scale has no sub-dimensions and is evaluated as a single factor. Cronbach's alpha coefficient of the scale was found to be 0.987.
1 secondary outcome
Quality of Life Scale for Schizophrenia
Time frame: From immediately before the interview began to 4 weeks after the interview.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Şeyda Erçel, MSc principal investigator
Ataturk University
Sibel Asi Karakaş principal investigator
Ataturk 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 Salutogenic Approach Based Interview in people with Schizophrenia, run by Ataturk 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şeyda Erçel, MSc (+90 539 493 37 90, seydaercel23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Recovery Assessment Scale (time frame: From immediately before the interview began to 4 weeks after the interview.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.