NCT07017881

Brief Summary

This study was conducted to investigate the effects of Psychosocial Skills Training on subjective recovery, self-esteem and quality of life levels of schizophrenia patients. The research is a randomized controlled trial. The research was conducted with 48 schizophrenia patients (Experimental: 24, Control: 24) registered in the Mental Health and Diseases Outpatient Clinic of a hospital. Personal Information Form, Subjective Recovery Assessment Scale, Rosenberg Self-Esteem Scale, Quality of Life Scale for Schizophrenia Patients were used to collect data. Data were collected by the researcher using the self-reporting face-to-face interview method in the form of pre-test and post-test. Psychosocial Skills Training was applied to the patients in the experimental group, one session per week, two days a week for 11 weeks, while the patients in the control group did not receive any intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4 days

First QC Date

May 25, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

schizophenia disorderpsychiatric nursingPsychosocial skills trainingquality of lifeself-esteemSubjective improvement

Outcome Measures

Primary Outcomes (1)

  • Subjective Improvement Total Score Average

    The scale is evaluated based on the total score and the total score varies between 17-85. Higher scores obtained from the scale indicate that the individual perceives himself/herself as better recovered.

    11 weeks from pre-test to end of training

Secondary Outcomes (2)

  • Rosenberg Self-Esteem Scale Society Score Average

    11 weeks from pre-test to end of training

  • Quality of Life Scale Total Score Average for Schizophrenia Patients

    11 weeks from pre-test to end of training

Study Arms (2)

control group

NO INTERVENTION

No intervention was applied. They continued their routine outpatient clinic check-ups and treatments.

intervention group

EXPERIMENTAL

The intervention group is a group of 24 schizophrenia patients who received 11 weeks of Psychosocial Skills Training.

Behavioral: Psychosocial Skills Training

Interventions

The 24-person intervention group was divided into three separate groups of 8 people (Group 1, Group 2, Group 3). Group 1 and Group 2 attended sessions on Tuesdays at different times, while Group 3 attended sessions on Thursdays. Psychosocial Skills Training consisted of eleven sessions in total, one session per week. Sessions lasted an average of 60 minutes for each group. In each session, 5-10 minute breaks were given for rest and eating and drinking, considering the attention span and fatigue of the patients. Psychosocial Skills Training was applied two days a week (Group 1-2: Tuesday, Group 3: Thursday) in order to ensure that the patients could get more benefit from the application.

intervention group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65,
  • Having been diagnosed with Schizophrenia for at least 6 months according to ICD-10,
  • Being registered with Selçuk University Medical Faculty Hospital Mental Health and Diseases Polyclinic,
  • Coming to polyclinic check-ups regularly,
  • Using antipsychotic medication regularly,
  • Being at least a primary school graduate,

You may not qualify if:

  • Having an organic mental disorder or mental retardation,
  • Having a visual or hearing impairment,
  • Participating in a program similar to the intervention to be implemented.
  • Not attending at least two sessions of Psychosocial Skills Training,
  • Having an exacerbation period/hospitalization and experiencing a physical discomfort at a level that prevents attending sessions during the program process,
  • Wanting to leave the study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Faculty of Medicine Hospital

Konya, Selçuklu, Turkey (Türkiye)

Location

Study Officials

  • Neslihan LÖK, Prof. Dr.

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample group was determined as 48 in total, 24 intervention and 24 control. Individuals were assigned to the intervention and control groups using the simple randomization method. The program was asked to randomly divide the files into two groups of 24 people each. The researcher randomly determined these two groups as the intervention (Set 1) and control (Set 2) groups. The 24 individuals constituting the intervention group were assigned to 3 separate groups of 8 people each (Group 1, Group 2, Group 3) using the block randomization method. In addition to their routine treatments, the intervention group received one session of psychosocial skills training per week. The control group continued their routine treatments.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Study Director

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 12, 2025

Study Start

August 5, 2024

Primary Completion

August 9, 2024

Study Completion

October 18, 2024

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations