NCT04740944

Brief 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. The control group continued their routine activities and was interviewed face-to-face 5 times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2021

Last Update Submit

February 3, 2021

Conditions

Keywords

Salutogenesissense of coherenceresilienceschizophrenia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Sense of Coherence Scale_13 (SOC_13)

    12 weeks

  • Brief Resilience Scale (BRS)

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

the intervention group was subjected to salutogenic approach-based interview consisting of 16 sessions twice a week.

Behavioral: Salutogenic Approach Based Interview

Control group

NO INTERVENTION

The control group continued their routine activities and was interviewed face-to-face 5 times.

Interventions

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Getting diagnosed with schizophrenia or schizoaffective disorder
  • Completing acute treatment and being at maintenance medication period

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa Institute of Granduate Studies

Istanbul, Turkey (Türkiye)

Location

Related Publications (30)

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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • 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/

    PMID: 28590620BACKGROUND
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    PMID: 23294596BACKGROUND
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    PMID: 19114439BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31411337BACKGROUND
  • Izydorczyk 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.

    PMID: 30970589BACKGROUND
  • 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.

    PMID: 30439796BACKGROUND
  • Jensen BB, Dur W, Buijs G. The Application of Salutogenesis in Schools. 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 22. Available from http://www.ncbi.nlm.nih.gov/books/NBK435853/

    PMID: 28590654BACKGROUND
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    PMID: 22220482BACKGROUND
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    PMID: 16242903BACKGROUND
  • 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, Lindstrom 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/

    PMID: 28590623BACKGROUND
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    PMID: 30087491BACKGROUND
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    PMID: 29975362BACKGROUND
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Related Links

MeSH Terms

Conditions

Mental DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • OZGUR S ACI, Dr

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 5, 2021

Study Start

December 31, 2018

Primary Completion

November 28, 2019

Study Completion

December 31, 2019

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

There is no plan to share to IPD

Locations