- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280835
Psychoeducation in Patients Who Diagnosed With Schizophrenia
The Effect of Group Psychoeducation That Focused on Social Skills Development Applied to Patients Who Diagnosed With Schizophrenia on Treatment Compliance, Quality of Life and Well-being
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim is to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.
The study was conducted with 42 schizophrenia patients (n=21 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication Adherence Rating Scale (MARS)", "Quality of Life Scale for Schizophrenia (QLSS)" and "Flourishing Scale" (FS). The measurements were taken 3 times: pre test, post-test and 3-months post-test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06500
- Merve Kızılırmak Tatu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteering
- Being 18 and over being literate
- Having been diagnosed with schizophrenia for at least three months
- Taking oral antipsychotics
- Being in remission.
Exclusion Criteria:
- Being in an acute period of exacerbation
- Actively using alcohol or psychoactive substances
- Having mental retardation or dementia
- Having another psychiatric illness that makes it impossible to cooperate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Psychoeducation that Focused on Social Skill Development
The Psychoeducation program that focused on social skill development, consists of 8 sessions, one day a week, each lasting an average of 60 Minutes.
Psychoeducation was conducted in three groups and each of them consisted of eight patients.
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Psychoeducation Program consists of; Preparatory Session, Recognition of Schizophrenia, Evaluating the Treatment of Schizophrenia, Stress and Coping with Stress, Improving Communication Skills, Improving Problem-solving Skills, Improving Interpersonal relationships and social activities and Evaluating Session.The sessions were held in the form of PowerPoint presentations.
In the psychoeducation program, lecture, question-answer, homework, sharing experiences, group discussion, repetition, video presentation, summarization, reinforcer, and role-playing techniques were used.
The day before each session, patients were phoned and reminded of the time of the session.
At the end of each session, the content of the subject is given as hard copy and cookies, tea and coffee were served.
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No Intervention: Control Group
No intervention was performed on the patients in the control group, and routine follow-up (arranging treatment by the doctor, answering the patient's and family's questions about treatment) continued in the polyclinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Scale for Schizophrenia (QLSS)
Time Frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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It evaluates the quality of life of schizophrenic patients receiving maintenance treatment.
QLSS provides information about ongoing symptoms and functionality.
It is a 7-degree Likert type scale applied in a semi-structured interview format.
It consists of a total of four sub-dimensions and 21 questions in the form of interpersonal relationships, professional role, psychic findings and daily item use-activities.
The total score of all subscales gives the total score (0-126) of quality of life.
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Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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Medication Adherence Rating Scale (MARS)
Time Frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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The scale assesses the patient's compliance behaviors and attitude to treatment.
The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high).
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Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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Flourishing Scale (FS)
Time Frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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It is a self-assessment scale measures an individual's level of well-being.
It consists of eight items and each item is scored 1-7 points.
The total score range from 8-56 points.
The more the score from the scale increases the more the well-being increases.
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Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merve Kızılırmak Tatu, PhD, Gazi University Health Science Faculty, Ankara, Turkey.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKTatu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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