NCT06820580

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Keywords

SchizophreniaSalutogenesisSubjective RecoveryQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    From immediately before the interview began to 4 weeks after the interview.

Secondary Outcomes (1)

  • Quality of Life Scale for Schizophrenia

    From immediately before the interview began to 4 weeks after the interview.

Study Arms (2)

Salutogenic Approach Based Interview Group

EXPERIMENTAL

Participants will be offered an 8-session Salutogenic Approach Based Interview Program two days a week.

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.

Interventions

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.

Salutogenic Approach Based Interview Group

Eligibility Criteria

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

You may qualify if:

  • years and older
  • The participant is in the recovery (remission) period
  • Being diagnosed with schizophrenia
  • Being suitable for group work

You may not qualify if:

  • The participant experienced an exacerbation (relapse) period
  • Presence of hearing and comprehension problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Community Mental Health Center

Elâzığ, Province, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Şeyda Erçel, MSc

    Ataturk University

    PRINCIPAL INVESTIGATOR
  • Sibel Asi Karakaş

    Ataturk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

February 20, 2025

Primary Completion

October 26, 2025

Study Completion

December 12, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations