- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872424
The Effect of Psychosocial Skills Focused Group Psychoeducation in Schizophrenia Patients (Schizophrenia)
March 10, 2025 updated by: Elif Güzide Emirza, Gazi University
The Effect of Psychosocial Skills Focused Group Psychoeducation on Functional Improvement, Treatment Compliance and Mental Well-Being in Schizophrenia Patients: a Randomised Controlled Study
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia.
This research will be conducted in Giresun Community Mental Health Center.
The study was planned as a randomized controlled pretest-posttest design.
In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data.
The sample size was calculated as 34 people (experimental group= 17, control group= 17).
Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia.
This research will be conducted in Giresun Community Mental Health Center.
The study was planned as a randomized controlled pretest-posttest design.
In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data.
The sample size was calculated as 34 people (experimental group= 17, control group= 17).
Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.
Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.
Thus, the effect of the psychoeducation program on the determined parameters will be evaluated.
After the completion of the research, short-term counseling services will be provided to the control group in line with ethical principles.
SPSS 25 package program will be used for data analysis.
Study Type
Interventional
Enrollment (Estimated)
34
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having a diagnosis of schizophrenia according to DSM-5 diagnostic criteria
- To have continuity in the Community Mental Health Center
- Being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor,
- To be mentally capable of understanding the questions posed
- To have the cognitive competence to understand the training provided
- Not having any visual or auditory disability
- Graduating from at least primary school
Exclusion Criteria:
- Refusing to participate in the study
- Being under 18 years of age
- Being illiterate in Turkish
- Having Mental Retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Effect of psychoeducation on schizophrenia patients
Experimental and control group
|
A 5-session Psychosocial Skills Focused Group Psychoeducation will be implemented, each session lasting approximately 60-90 minutes.
In order to make the training more active and effective, the experimental group will be divided into small groups and divided into 3 groups and each group will be given 5 sessions of Psychosocial Skills Focused Group Psychoeducation once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Recovery Scale in Schizophrenia
Time Frame: 1 day
|
Functional Recovery Scale: The scale is 5-point Likert-type and consists of 19 items.
The maximum score that can be obtained from the scale is 95 and the minimum score is 19.
Patients who score below 58 points are considered to have a low level of Functional Recovery, patients who score between 59-65 points are considered to have a moderate level of Functional Recovery, and patients who score 66 points and above are considered to have a high level.
|
1 day
|
|
Morisky Treatment Adherence Scale
Time Frame: 1 day
|
Morisky Treatment Adherence Scale: The scale consists of 4 closed-ended questions with two options (yes/no).
Medication adherence is assessed as high if "no" is answered to all questions (4 points), moderate if "yes" is answered to one or two questions (2-3 points), and low if "yes" is answered to three or four questions (0-1 pn).
|
1 day
|
|
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 1 day
|
Warwick-Edinburgh Mental Well-Being Scale: The scale consists of 14 items and each question is scored between 1-5.
The total score range is 14-70.
A higher score indicates a higher level of mental well-being.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 15, 2025
Primary Completion (Estimated)
July 15, 2025
Study Completion (Estimated)
August 15, 2025
Study Registration Dates
First Submitted
February 27, 2025
First Submitted That Met QC Criteria
March 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGUEM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.