search
Back to results

Psychoeducation in Patients Who Diagnosed With Schizophrenia

Primary Purpose

Quality of Life, Well-Being, Compliance, Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group Psychoeducation that Focused on Social Skill Development
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring schizophrenia, psychoeducation, compliance to treatment, quality of life, well-being

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Merve Kızılırmak Tatu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Psychoeducation that Focused on Social Skill Development

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Life Scale for Schizophrenia (QLSS)
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.
Medication Adherence Rating Scale (MARS)
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).
Flourishing Scale (FS)
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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2020
Last Updated
February 20, 2020
Sponsor
Gazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT04280835
Brief Title
Psychoeducation in Patients Who Diagnosed With Schizophrenia
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. It is known that psychoeducation practices aimed at developing social skills in schizophrenia give patients new skills and these skills continue for many years. This study aimed 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Well-Being, Compliance, Treatment
Keywords
schizophrenia, psychoeducation, compliance to treatment, quality of life, well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research was using quasi-experimental research methods. The experimental group was composed of patients with schizophrenia registered at Community Mental Health Center and the control group was composed of outpatients diagnosed with schizophrenia who applied to Psychiatric Polyclinic.The patients met the inclusion criteria of the study and volunteered to participate in the study.The study was completed with 42 patients (n=21for the intervention group; n=21 patients for the control group).Psychoeducation program were applied to intervention group. No intervention was performed on the patients in the control group.To the experimental and control group, at screening (pre-test), eight weeks after screening (post-intervention/post-test), three months after the post tests (follow-up) was applied.The mesurements were taken simultaneously in the intervention and control groups.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Psychoeducation that Focused on Social Skill Development
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Psychoeducation that Focused on Social Skill Development
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life Scale for Schizophrenia (QLSS)
Description
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.
Time Frame
Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
Title
Medication Adherence Rating Scale (MARS)
Description
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).
Time Frame
Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
Title
Flourishing Scale (FS)
Description
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.
Time Frame
Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Kızılırmak Tatu, PhD
Organizational Affiliation
Gazi University Health Science Faculty, Ankara, Turkey.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merve Kızılırmak Tatu
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.

Learn more about this trial

Psychoeducation in Patients Who Diagnosed With Schizophrenia

We'll reach out to this number within 24 hrs