Schizophrenia Clinical Trial
Official title:
The Effect of Salutogenic Approach Based Interview on Sense of Coherence and Psychological Resistance of People With Schizophrenia: A Randomized Controlled Trial
Verified date | February 2021 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 31, 2019 |
Est. primary completion date | November 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria of the study: - Getting diagnosed with schizophrenia or schizoaffective disorder - Completing acute treatment and being at maintenance medication period Exclusion criteria of the study - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University - Cerrahpasa Institute of Granduate Studies | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
Arvidsdotter T, Marklund B, Taft C, Kylén 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. — View Citation
Badura-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. — View Citation
Bag B, Salutogenic model in mental health and psychiatric nursing. Current Approaches in Psychiatry. 2017:9: 284-300.
Bas AU, Yurdabakan I. 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. — View Citation
Bengtsson-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. — View Citation
Bilge A, Mermer G, Çam O, Çetinkaya A, Erdogan E, Üçkuyu N. Profile of community mental health centers in Turkey between 2013-2015 years. Journal of Health Sciences of Kocaeli University. 2016;(2): 1-5.
Çapan BE, Aricioglu A. Forgiveness as predictor of psychological resiliency. e-International Journal of Educational Research. 2014;(5): 70-82.
Dogan 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, Lindström 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/ — View Citation
Forsberg KA, Björkman T, Sandman PO, Sandlund M. Influence of a lifestyle intervention among persons with a psychiatric disability: a cluster randomised controlled trail on symptoms, quality of life and sense of coherence. J Clin Nurs. 2010 Jun;19(11-12): — View Citation
Gassmann 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. — View Citation
Griffiths 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.
Griffiths CA. Sense of coherence and mental health rehabilitation. Clin Rehabil. 2009 Jan;23(1):72-8. doi: 10.1177/0269215508095360. Review. — View Citation
Hjelle EG, Bragstad LK, Kirkevold M, Zucknick M, Bronken BA, Martinsen R, Kvigne KJ, Kitzmüller 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. — View Citation
Izydorczyk B, Sitnik-Warchulska K, Kühn-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). pii: E1266. doi: 10.3390/ijerph16071266. — View Citation
Jakovljevic M. Empathy, Sense of Coherence and Resilience: Bridging Personal, Public and Global Mental Health and Conceptual Synthesis. Psychiatr Danub. 2018 Dec;30(4):380-384. doi: 10.24869/psyd.2018.380. — View Citation
Jensen BB, Dür W, Buijs G. The Application of Salutogenesis in Schools. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindström B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 22. Available from http://www.ncbi.nlm.nih.gov/books/NBK435853/ — View Citation
Kasperek-Zimowska B, Chadzynska M. [Sense of coherence and coping styles among parents of adult children with schizophrenia]. Psychiatr Pol. 2011 Sep-Oct;45(5):643-52. Polish. — View Citation
Korlin D, Wrangsjo B. Treatment effects of GIM therapy. Nordic Journal of Music Therapy. 2002.(11): 3-15.
Köroglu A, Hocaoglu Ç. The effect of schizophrenia on the family. Journal of Duzce Univertsity Health Sciences Institute. 2017;(7): 170-175.
Langeland E, Riise T, Hanestad BR, Nortvedt MW, Kristoffersen K, Wahl AK. The effect of salutogenic treatment principles on coping with mental health problems A randomised controlled trial. Patient Educ Couns. 2006 Aug;62(2):212-9. Epub 2005 Oct 19. — View Citation
Langeland E, Sense of coherence and life satisfaction in people suffering from mental health problems. An intervention study in talk-therapy groups with focus on salutogenesis. Doctoral Thesis, Dissertation for The Degree Doctor Rerum Politicarum, University of Bergen, Norway.(2007).
Langeland E, Vinje HF. The Application of Salutogenesis in Mental Healthcare Settings. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindström B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 28. Available from http://www.ncbi.nlm.nih.gov/books/NBK435815/ — View Citation
Menzies V. Depression in schizophrenia: nursing care as a generalized resistance resource. Issues Ment Health Nurs. 2000 Sep;21(6):605-17. Review. — View Citation
Pétavy F, Guizzaro L, Antunes Dos Reis I, Teerenstra S, Roes KCB. Beyond "Intent-to-treat" and "Per protocol": Improving assessment of treatment effects in clinical trials through the specification of an estimand. Br J Clin Pharmacol. 2020 Jul;86(7):1235-1239. doi: 10.1111/bcp.14195. Epub 2020 Mar 27. — View Citation
Schrank B, Brownell T, Jakaite Z, Larkin C, Pesola F, Riches S, Tylee A, Slade M. Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial. Epidemiol Psychiatr Sci. 2016 Jun;25(3):235-46. doi: 10.1017/S2045796015000141. Epub 2015 Feb 20. — View Citation
Tan KK, Chan SWC, Vehviläinen-Julkunen K. Self-care program for older Community-dwellers: protocol for a randomized controlled trial. Central European Journal of Nursing and Midwifery. 2014; 5(4): 145-155.
Veltro F, Nicchiniello I, Pica A, Pontarelli I, Iannone C, Pontarelli C, Zappone L, Vendittelli N. Description and impact of a structured psychoeducational and salutogenetic approach (InteGRO) to support the recovery of people with severe mental disorders. Riv Psichiatr. 2018 Jul-Aug;53(4):205-213. doi: 10.1708/2954.29697. Italian. — View Citation
Witkowska-Luc B. Schizophrenia and sense of coherence. Psychiatr Pol. 2018 Apr 30;52(2):217-226. doi: 10.12740/PP/OnlineFirst/69697. Epub 2017 Jun 29. English, Polish. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 weeks | |
Primary | 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. | 8 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks |
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