NCT04280835

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable quality-of-life

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

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 17, 2020

Last Update Submit

February 20, 2020

Conditions

Keywords

schizophreniapsychoeducationcompliance to treatmentquality of lifewell-being

Outcome Measures

Primary Outcomes (3)

  • 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.

    Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)

  • 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).

    Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)

  • 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.

    Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)

Study Arms (2)

Group Psychoeducation that Focused on Social Skill Development

EXPERIMENTAL

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.

Behavioral: Group Psychoeducation that Focused on Social Skill Development

Control Group

NO INTERVENTION

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.

Interventions

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.

Group Psychoeducation that Focused on Social Skill Development

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering
  • Being 18 and over being literate
  • Having been diagnosed with schizophrenia for at least three months
  • Taking oral antipsychotics
  • Being in remission.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Kızılırmak Tatu

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient ComplianceSchizophrenia

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Merve Kızılırmak Tatu, PhD

    Gazi University Health Science Faculty, Ankara, Turkey.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 21, 2020

Study Start

January 1, 2019

Primary Completion

March 30, 2019

Study Completion

June 30, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

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.

Locations