SalutogenesisNCT04740944
Salutogenic Approach Based Interview With People With Schizophrenia
A study testing Salutogenic Approach Based Interview in people with Salutogenesis and Mental Health Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study determines the effectiveness of the interviewing based on salutogenic approach on the sense of coherence and resilience of people with schizophrenia. For this, while the intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Salutogenesis, Mental Health Disorder, Schizophrenia
- What is being tested?
- Salutogenic Approach Based Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2018to 31 Dec 2019
- 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
- Getting diagnosed with schizophrenia or schizoaffective disorder
- Completing acute treatment and being at maintenance medication period
Who cannot join
- Being at the period of psychotic relapse
- Having mental development disorder
- Being under the influence of alcohol-drugs
- Having diagnosed with personal disorder
- Being considered unsuitable to include in the group study by doctors and nurses of CMHC.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa Institute of Granduate Studies
Istanbul
About this study
Official title: The Effect of Salutogenic Approach Based Interview on Sense of Coherence and Psychological Resistance of People With Schizophrenia: A Randomized Controlled Trial
This study determines the effectiveness of the interviewing based on salutogenic approach on the sense of coherence and resilience of people with schizophrenia. For this, while the intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week. The control group continued their routine activities and was interviewed face-to-face 5 times.
Read the detailed description
Schizophrenia is a chronic and serious disease that affecting 20 million people in the world. Because of the problems these individuals face in cognitive, emotional, and behavioral domains, they have frequently difficulty in adapting to their environment, have to struggle against stigmatization, have an increased risk of committing suicide due to ever decreasing functioning and hopelessness they experience, and they need a long-term care and support due to their difficulty in compliance to treatment.
The sense of coherence and resilience are important components for individuals diagnosed with schizophrenia to cope with problems in cognitive, emotional, and behavioral domains. Sense of coherence reflects the capacity of a person to respond stressful situations. It is associated with a person's emotional responses and resources, making sense of the world, use of required resources, and respond to demands. Powerful sense of coherence helps a person to protect own health, to cope with the stress factors, to manage the strain, and to activate their resources.
Resilience is described as the capacity of individuals to recover or adapt after problems, difficult periods, and stressful life crises that they face during their life. This term can also be understood as the ability to ensure and/or maintain a state of coherence.
The model addressing the concepts of sense of coherence and resilience is salutogenic model. Salutogenic model (1996) which was developed by Aaron Antonovsky (1923-1994) is an alternative model to pathogenesis approach. While pathogenesis focuses on how the disease has occurred, salutogenesis focuses on how wellbeing is formed. Salutogenic approach attempts to explain why some people better cope with the strain, stressful life events and difficulties they face and how they maintain their health and wellbeing better compared to others. The most significant factor in personal evaluation of an external stimulus and in coping with the strain is explained with sense of coherence which is specified in the model. Sense of coherence is the fundamental concept of salutogenic theory and consists of three components. These are comprehensibility, manageability, and meaningfulness. Comprehensibility expresses that internal and external stressors experienced by a person are "expected" and "explainable" in the life. Manageability is the sense about that individual has the internal and external resources to cope with the situation caused by stressor. Meaningfulness states a person's perception on how they struggle against negative life events.
Lindström and Eriksson (2010) describe salutogenesis as an "umbrella". Under this umbrella, there are also concepts of "empowerment", "self-efficacy", "quality of life", "resilience", "welfare", and "competence" as well as the sense of coherence. It is accepted that all of these concepts are associated with salutogenic dimensions and provide significant contributions to describe, explain, analyze, and promote health.
There are studies applying intervention programs based on salutogenic model in people with mental disorder or groups at risk in terms of mental disorder. The first intervention program based on salutogenic model is talk therapy. The major goal of this application is to increase awareness and confidence of the participants and to promote their sense of coherence, coping skills, mental health, and welfare level by allowing them to recognize internal/external resources and potentials. With the talk therapy application, it is provided to manage stressful situations effectively by bringing out personal and collective resistance resources.
The intervention based on salutogenic model has five fundamental components. (1) Sustainability of health, (2) Story of the person, (3) Factors to promote health, (4) Understanding the health promotion power of tension and strain, (5) Active adaptation.
Traditional therapy which is recommended for recovery focuses on negative life events, diagnosis, and medication. In the talk therapy based on salutogenic approach, resources and coping potential of a person are addressed and three recovery factors are focused for the recovery process. These factors are (1) participants' perception about themselves as more than only a diagnosis and disease, (2) getting respected about discovering themselves and getting discovered by other people, (3) having control of their own lives. Psychiatric nurses take part as group leaders in the intervention. Focus of the talk therapies is their speech.
It is stated that it could be possible for a person diagnosed with schizophrenia to gradually regain the ability of functioning independently, to rebuild family relationships, and to fulfil professional roles and functions with the practices to be made by the help of salutogenic model. Therefore, these people should be empowered to decide about their lives. By this means, it is possible to lead a satisfying life for them against the restrictions caused by the disease. A study evaluating sense of coherence and quality of life for people diagnosed with schizophrenia revealed that sense of coherence was an indicator for the quality of life. Bengtsson-Tops and Hansson (2001) concluded in their literature review on sense of coherence that the studies using methods regarding care, support and recovery of people diagnosed with schizophrenia or schizoaffective disorder could be useful in terms of recovery. In the light of these findings, Bengtsson-Tops and Hansson concluded that actions to improve cognitive abilities of people in order to facilitate the recovery could be increased by the concepts of sense of coherence. Menzies (2000) providing detailed information about how salutogenic approach should be applied for a person diagnosed with schizophrenia highlighted that psychiatric nurse would develop a person's hopes allowing them to cope with symptoms and problems, would enhance their self-esteem supporting their abilities and skills, would contribute development of their personal identity, and would increase the sense of coherence.
It is stated in the literature that practices based on salutogenic model and talk therapy based on this model could be used for people diagnosed with schizophrenia. In the international literature, there is no study in which salutogenic-based talk therapy program is applied to only people diagnosed with schizophrenia. In Turkey, there has been no study examining the efficacy of any intervention program based on this model.
- Being tested
- Salutogenic Approach Based Interview
- Keywords
- Salutogenesis, sense of coherence, resilience, schizophrenia
- Medical subject headings
- Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salutogenic Approach Based InterviewBehavioural
Salutogenic Approach Based Interview has five basic components. (1) Continuity of health, (2) The story of the person, (3) Health promoting factors, (4) Understanding the health promoting power of tension and strain, (5) Active adaptation In traditional therapy recommended for recovery, more emphasis is placed on negative life events, diagnosis and medication. In the salutogenic approach-based interview, the resources and coping potential of the person are discussed and three healing factors are focused on for the recovery process. These factors are that the participants (1) perceive themselves as more than just a diagnosis and disease, (2) self-discovery and respect for other people's self-discovery, (3) control over their own lives. In the intervention, mental health nurses take part as group leaders. The focus in interviews is therapeutic conversations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | the intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week. Receives: Behavioral: Salutogenic Approach Based Interview |
| Control group | No intervention | The control group continued their routine activities and was interviewed face-to-face 5 times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense of Coherence Scale_13 (SOC_13)
At the end of 8 weeks (16 sessions of salutogenic approach based interview ), they were evaluated using the sense of coherence scale which was developed by Antonovsky (1987) is a self-report scale consisting of a total of 13 items ranging between 1 and 7. The scale allows to use subscale scores and calculate total score. Higher scale scores indicate that individual has higher sense of coherence. In the reliability studies of the original version of the scale, internal consistency coefficients were calculated as .62 for "meaningfulness", .54 for "manageability", .57 for "comprehensibility", and .69 for overall scale.
Measured: 8 weeks
Brief Resilience Scale (BRS)
At the end of 8 weeks (16 sessions of salutogenic approach based interview ), they were evaluated using brief resilience scale which was developed by Smith et al., (2008) to measure resilience of individuals. The scale is a 5-point likert self-report assessment instrument with 6 items. High BRS scores signify higher resilience of a person.
Measured: 8 weeks
Secondary outcomes (2)
Sense of Coherence Scale_13 (SOC_13)
At the end of 12 weeks (16 sessions of salutogenic approach based interview + 1 month), they were evaluated using the sense of coherence scale which was developed by Antonovsky (1987) is a self-report scale consisting of a total of 13 items ranging between 1 and 7. The scale allows to use subscale scores and calculate total score. Higher scale scores indicate that individual has higher sense of coherence. In the reliability studies of the original version of the scale, internal consistency coefficients were calculated as .62 for "meaningfulness", .54 for "manageability", .57 for "comprehensibility", and .69 for overall scale.
Measured: 12 weeks
Brief Resilience Scale (BRS)
At the end of 8 weeks (16 sessions of salutogenic approach based interview ), they were evaluated using brief resilience scale which was developed by Smith et al., (2008) to measure resilience of individuals. The scale is a 5-point likert self-report assessment instrument with 6 items. High BRS scores signify higher resilience of a person.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start31 Dec 2018
- Primary completion28 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for SalutogenesisStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Sema ACI, Istanbul University - Cerrahpasa
- Investigators
- OZGUR S ACI, Dr, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740944
- Sponsor's protocol ID
- Nurse_Psychiatric
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share to IPD
Publications
Arvidsdotter T, Marklund B, Taft C, Kylen S. Quality of life, sense of coherence and experiences with three different treatments in patients with psychological distress in primary care: a mixed-methods study. BMC Complement Altern Med. 2015 Apr 26;15:132. doi: 10.1186/s12906-015-0654-z.
PubMed 25928131Badura-Brzoza K, Zajac P, Matysiakiewicz J, Piegza M, Rycerski W, Hese RT, Koczy B, Semenowicz J. [The association of quality of life with mental status and sociodemographic data in patients after total hip replacement]. Psychiatr Pol. 2008 Mar-Apr;42(2):261-9. Polish.
PubMed 19697531Bag B, Salutogenic model in mental health and psychiatric nursing. Current Approaches in Psychiatry. 2017:9: 284-300.
Baş AU, Yurdabakan İ. The predictive value of resilience and school climate in life satisfaction among middle school students. Mehmet Akif Ersoy University Journal of Education Faculty. 2017;1: 202-214.
Bengtsson-Tops A, Brunt D, Rask M. The structure of Antonovsky's sense of coherence in patients with schizophrenia and its relationship to psychopathology. Scand J Caring Sci. 2005 Sep;19(3):280-7. doi: 10.1111/j.1471-6712.2005.00342.x.
PubMed 16101857Bengtsson-Tops A, Hansson L. The validity of Antonovsky's Sense of Coherence measure in a sample of schizophrenic patients living in the community. J Adv Nurs. 2001 Feb;33(4):432-8. doi: 10.1046/j.1365-2648.2001.01692.x.
PubMed 11251730Bilge A, Mermer G, Çam O, Çetinkaya A, Erdoğan E, Üçkuyu N. Profıle of communıty mental health centers in Turkey between 2013-2015 years. Journal of Health Sciences of Kocaeli University. 2016;(2): 1-5.
Çapan BE, Arıcıoğlu A. Forgiveness as predictor of psychological resiliency. e-International Journal of Educational Research. 2014;(5): 70-82.
Doğan T. Adaptation of the brief resilience scale into Turkish: A validity and reliability study. The Journal of Happiness ve Well-Being. 2015;3: 93-102.
Eriksson M. The Sense of Coherence in the Salutogenic Model of Health. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK435812/
PubMed 28590620Gassmann W, Christ O, Lampert J, Berger H. The influence of Antonovsky's sense of coherence (SOC) and psychoeducational family intervention (PEFI) on schizophrenic outpatients' perceived quality of life: a longitudinal field study. BMC Psychiatry. 2013 Jan 7;13:10. doi: 10.1186/1471-244X-13-10.
PubMed 23294596Griffiths CA. Sense of coherence and mental health rehabilitation. Clin Rehabil. 2009 Jan;23(1):72-8. doi: 10.1177/0269215508095360.
PubMed 19114439Griffiths CA. A critical analysis of Antonovsky's sense of coherence theory in relation to mental health and mental disorder and the effect of a lifelong learning intervention on the sense of coherence of mental health service users, Doktoral Thesis, Middlesex University.Dubai. 2010.
Hjelle EG, Bragstad LK, Kirkevold M, Zucknick M, Bronken BA, Martinsen R, Kvigne KJ, Kitzmuller G, Mangset M, Thommessen B, Sveen U. Effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke in Norway: A randomized controlled trial. J Rehabil Med. 2019 Sep 3;51(8):557-565. doi: 10.2340/16501977-2585.
PubMed 31411337Izydorczyk B, Sitnik-Warchulska K, Kuhn-Dymecka A, Lizinczyk S. Resilience, Sense of Coherence, and Coping with Stress as Predictors of Psychological Well-Being in the Course of Schizophrenia. The Study Design. Int J Environ Res Public Health. 2019 Apr 9;16(7):1266. doi: 10.3390/ijerph16071266.
PubMed 30970589
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salutogenic Approach Based Interview on Sense of Coherence and Psychological Resistance of People With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04740944
- Acronym / sponsor ID
- Nurse_Psychiatric
- Keywords
- Salutogenesis, sense of coherence, resilience, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Feb 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.
This study determines the effectiveness of the interviewing based on salutogenic approach on the sense of coherence and resilience of people with schizophrenia. For this, while the intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week. The control group continued their routine activities and was interviewed face-to-face 5 times.
Detailed description
Schizophrenia is a chronic and serious disease that affecting 20 million people in the world. Because of the problems these individuals face in cognitive, emotional, and behavioral domains, they have frequently difficulty in adapting to their environment, have to struggle against stigmatization, have an increased risk of committing suicide due to ever decreasing functioning and hopelessness they experience, and they need a long-term care and support due to their difficulty in compliance to treatment.
The sense of coherence and resilience are important components for individuals diagnosed with schizophrenia to cope with problems in cognitive, emotional, and behavioral domains. Sense of coherence reflects the capacity of a person to respond stressful situations. It is associated with a person's emotional responses and resources, making sense of the world, use of required resources, and respond to demands. Powerful sense of coherence helps a person to protect own health, to cope with the stress factors, to manage the strain, and to activate their resources.
Resilience is described as the capacity of individuals to recover or adapt after problems, difficult periods, and stressful life crises that they face during their life. This term can also be understood as the ability to ensure and/or maintain a state of coherence.
The model addressing the concepts of sense of coherence and resilience is salutogenic model. Salutogenic model (1996) which was developed by Aaron Antonovsky (1923-1994) is an alternative model to pathogenesis approach. While pathogenesis focuses on how the disease has occurred, salutogenesis focuses on how wellbeing is formed. Salutogenic approach attempts to explain why some people better cope with the strain, stressful life events and difficulties they face and how they maintain their health and wellbeing better compared to others. The most significant factor in personal evaluation of an external stimulus and in coping with the strain is explained with sense of coherence which is specified in the model. Sense of coherence is the fundamental concept of salutogenic theory and consists of three components. These are comprehensibility, manageability, and meaningfulness. Comprehensibility expresses that internal and external stressors experienced by a person are "expected" and "explainable" in the life. Manageability is the sense about that individual has the internal and external resources to cope with the situation caused by stressor. Meaningfulness states a person's perception on how they struggle against negative life events.
Lindström and Eriksson (2010) describe salutogenesis as an "umbrella". Under this umbrella, there are also concepts of "empowerment", "self-efficacy", "quality of life", "resilience", "welfare", and "competence" as well as the sense of coherence. It is accepted that all of these concepts are associated with salutogenic dimensions and provide significant contributions to describe, explain, analyze, and promote health.
There are studies applying intervention programs based on salutogenic model in people with mental disorder or groups at risk in terms of mental disorder. The first intervention program based on salutogenic model is talk therapy. The major goal of this application is to increase awareness and confidence of the participants and to promote their sense of coherence, coping skills, mental health, and welfare level by allowing them to recognize internal/external resources and potentials. With the talk therapy application, it is provided to manage stressful situations effectively by bringing out personal and collective resistance resources.
The intervention based on salutogenic model has five fundamental components. (1) Sustainability of health, (2) Story of the person, (3) Factors to promote health, (4) Understanding the health promotion power of tension and strain, (5) Active adaptation.
Traditional therapy which is recommended for recovery focuses on negative life events, diagnosis, and medication. In the talk therapy based on salutogenic approach, resources and coping potential of a person are addressed and three recovery factors are focused for the recovery process. These factors are (1) participants' perception about themselves as more than only a diagnosis and disease, (2) getting respected about discovering themselves and getting discovered by other people, (3) having control of their own lives. Psychiatric nurses take part as group leaders in the intervention. Focus of the talk therapies is their speech.
It is stated that it could be possible for a person diagnosed with schizophrenia to gradually regain the ability of functioning independently, to rebuild family relationships, and to fulfil professional roles and functions with the practices to be made by the help of salutogenic model. Therefore, these people should be empowered to decide about their lives. By this means, it is possible to lead a satisfying life for them against the restrictions caused by the disease. A study evaluating sense of coherence and quality of life for people diagnosed with schizophrenia revealed that sense of coherence was an indicator for the quality of life. Bengtsson-Tops and Hansson (2001) concluded in their literature review on sense of coherence that the studies using methods regarding care, support and recovery of people diagnosed with schizophrenia or schizoaffective disorder could be useful in terms of recovery. In the light of these findings, Bengtsson-Tops and Hansson concluded that actions to improve cognitive abilities of people in order to facilitate the recovery could be increased by the concepts of sense of coherence. Menzies (2000) providing detailed information about how salutogenic approach should be applied for a person diagnosed with schizophrenia highlighted that psychiatric nurse would develop a person's hopes allowing them to cope with symptoms and problems, would enhance their self-esteem supporting their abilities and skills, would contribute development of their personal identity, and would increase the sense of coherence.
It is stated in the literature that practices based on salutogenic model and talk therapy based on this model could be used for people diagnosed with schizophrenia. In the international literature, there is no study in which salutogenic-based talk therapy program is applied to only people diagnosed with schizophrenia. In Turkey, there has been no study examining the efficacy of any intervention program based on this model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Salutogenic Approach Based Interviewthe intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week. |
| Control group | No intervention | –The control group continued their routine activities and was interviewed face-to-face 5 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Getting diagnosed with schizophrenia or schizoaffective disorder
- Completing acute treatment and being at maintenance medication period
Key exclusion criteria (5 listed)
- Being at the period of psychotic relapse
- Having mental development disorder
- Being under the influence of alcohol-drugs
- Having diagnosed with personal disorder
- Being considered unsuitable to include in the group study by doctors and nurses of CMHC.
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 Interview has five basic components. (1) Continuity of health, (2) The story of the person, (3) Health promoting factors, (4) Understanding the health promoting power of tension and strain, (5) Active adaptation In traditional therapy recommended for recovery, more emphasis is placed on negative life events, diagnosis and medication. In the salutogenic approach-based interview, the resources and coping potential of the person are discussed and three healing factors are focused on for the recovery process. These factors are that the participants (1) perceive themselves as more than just a diagnosis and disease, (2) self-discovery and respect for other people's self-discovery, (3) control over their own lives. In the intervention, mental health nurses take part as group leaders. The focus in interviews is therapeutic conversations. | Behavioural | Intervention group |
Primary outcome
Sense of Coherence Scale_13 (SOC_13)
Time frame: 8 weeks
At the end of 8 weeks (16 sessions of salutogenic approach based interview ), they were evaluated using the sense of coherence scale which was developed by Antonovsky (1987) is a self-report scale consisting of a total of 13 items ranging between 1 and 7. The scale allows to use subscale scores and calculate total score. Higher scale scores indicate that individual has higher sense of coherence. In the reliability studies of the original version of the scale, internal consistency coefficients were calculated as .62 for "meaningfulness", .54 for "manageability", .57 for "comprehensibility", and .69 for overall scale.
Brief Resilience Scale (BRS)
Time frame: 8 weeks
At the end of 8 weeks (16 sessions of salutogenic approach based interview ), they were evaluated using brief resilience scale which was developed by Smith et al., (2008) to measure resilience of individuals. The scale is a 5-point likert self-report assessment instrument with 6 items. High BRS scores signify higher resilience of a person.
2 secondary outcomes
Sense of Coherence Scale_13 (SOC_13)
Time frame: 12 weeks
Brief Resilience Scale (BRS)
Time frame: 12 weeks
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 5 Feb 2021.
- Background: PubMed 25928131Arvidsdotter T, Marklund B, Taft C, Kylen S. Quality of life, sense of coherence and experiences with three different treatments in patients with psychological distress in primary care: a mixed-methods study. BMC Complement Altern Med. 2015 Apr 26;15:132. doi: 10.1186/s12906-015-0654-z.
- Background: PubMed 19697531Badura-Brzoza K, Zajac P, Matysiakiewicz J, Piegza M, Rycerski W, Hese RT, Koczy B, Semenowicz J. [The association of quality of life with mental status and sociodemographic data in patients after total hip replacement]. Psychiatr Pol. 2008 Mar-Apr;42(2):261-9. Polish.
- BackgroundBag B, Salutogenic model in mental health and psychiatric nursing. Current Approaches in Psychiatry. 2017:9: 284-300.
- BackgroundBaş AU, Yurdabakan İ. The predictive value of resilience and school climate in life satisfaction among middle school students. Mehmet Akif Ersoy University Journal of Education Faculty. 2017;1: 202-214.
- Background: PubMed 16101857Bengtsson-Tops A, Brunt D, Rask M. The structure of Antonovsky's sense of coherence in patients with schizophrenia and its relationship to psychopathology. Scand J Caring Sci. 2005 Sep;19(3):280-7. doi: 10.1111/j.1471-6712.2005.00342.x.
- Background: PubMed 11251730Bengtsson-Tops A, Hansson L. The validity of Antonovsky's Sense of Coherence measure in a sample of schizophrenic patients living in the community. J Adv Nurs. 2001 Feb;33(4):432-8. doi: 10.1046/j.1365-2648.2001.01692.x.
- BackgroundBilge A, Mermer G, Çam O, Çetinkaya A, Erdoğan E, Üçkuyu N. Profıle of communıty mental health centers in Turkey between 2013-2015 years. Journal of Health Sciences of Kocaeli University. 2016;(2): 1-5.
- BackgroundÇapan BE, Arıcıoğlu A. Forgiveness as predictor of psychological resiliency. e-International Journal of Educational Research. 2014;(5): 70-82.
- BackgroundDoğan T. Adaptation of the brief resilience scale into Turkish: A validity and reliability study. The Journal of Happiness ve Well-Being. 2015;3: 93-102.
- Background: PubMed 28590620Eriksson M. The Sense of Coherence in the Salutogenic Model of Health. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK435812/
- Background: PubMed 23294596Gassmann W, Christ O, Lampert J, Berger H. The influence of Antonovsky's sense of coherence (SOC) and psychoeducational family intervention (PEFI) on schizophrenic outpatients' perceived quality of life: a longitudinal field study. BMC Psychiatry. 2013 Jan 7;13:10. doi: 10.1186/1471-244X-13-10.
- Background: PubMed 19114439Griffiths CA. Sense of coherence and mental health rehabilitation. Clin Rehabil. 2009 Jan;23(1):72-8. doi: 10.1177/0269215508095360.
- WHO (2019) World Health ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share to IPD
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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.
OZGUR S ACI, Dr principal investigator
Istanbul University - Cerrahpasa
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 Salutogenesis and Mental Health Disorder, run by Istanbul University - Cerrahpasa 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 2 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 5 Feb 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?
Sense of Coherence Scale_13 (SOC_13) (time frame: 8 weeks). 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 NCT04740944, which also lists 30 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 5 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.