NCT05074004

Brief Summary

Background: Psychoeducation is a process used in the realization of the principles of treatment and rehabilitation of mental illnesses and aims to help the patient and his/her family outside the hospital, to help the patient cope with the problems, experiencing, and to support them to live productive lives in society. Aims: This study aims to determine the effect of psychoeducation, given in a psychiatry dayhospital, on patients' self-sufficiency and well-being. Methods: The research is a single-blind randomized controlled experimental study. The sample of the study consisted of 28 schizophrenic patient(14experiment-14control), who agreed to participate in the study, followed in XXX University Psychiatry Day Hospital. In the study, an 8-week psychoeducation program was applied to the experimental group, and no intervention was made tothe control group. Socio-demographic data form, self-sufficiency scale, and well-being scale were used as data collection tools. The data obtained were analyzed using theSPSS-23 package program. Results: After the eight-week psychoeducation program, the pretest and posttest scores of the evaluations obtained from the scales of both groups were compared. It was found that while there was no change in thescores of the control group, there was an increase in the well-being and self-efficacy scores of the experimental group. While the increase in well-being was statistically significant(p\<0.05), the increase in self-sufficiency score wasnot statistically significant(p\>0.05), but the numerical increase was considered tobe aclinically significant result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

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

February 15, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

Same day

First QC Date

September 8, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

chronic mental disorderself-sufficiencywell-beingpsychoeducationpsychiatric nurseTurkey

Outcome Measures

Primary Outcomes (3)

  • Socio-demographic Data Form

    The form prepared by the researchers using the literature contains questions about the health status and the sociodemographic characteristics of individuals diagnosed with psychiatric diseases, such as age, gender, marital status, and educational status.

    pre-intervention

  • General Self-Sufficiency Scale

    The Turkish adaptation of the scale developed by Sherer et al. (1982) was carried out by Yıldırım \& İlhan (2010). The scale with a 5-point Likert structure consists of 17 items. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16 and 17 are scored in reverse. The total score that can be obtained varies between 17 and 85, and the increase in the score indicates increased self-sufficiency belief. The scale was applied by Yıldırım \& İlhan (2010) to 895 people aged 18 and over with at least five years of education. In the reliability study, the internal consistency coefficient was calculated as α = .80 for the whole scale and between .78 and .81 for each subscale.

    pre-intervention

  • Well-being Scale

    The Turkish adaptation study of the Well-Being Scale developed by Diener et al. (2009) was carried out by Fidan and Usta (2013). The scale has a 7-point Likert structure. The highest score that can be obtained from the scale is 56, and the lowest score is 8. There are no reverse-scored items on the scale. High scores from the scale indicate that the relevant individual has a high level of well-being. The reliability study of the scale was conducted by Fidan and Usta (2013) on a total of 385 high school 4th-grade students, 166 (43%) female and 219 (57%) male. The Cronbach alpha internal consistency coefficient of the Well-Being Scale was reported as .83.

    pre-intervention

Secondary Outcomes (2)

  • General Self-Sufficiency Scale:

    immediately after the interventio

  • Well-being Scale:

    immediately after the interventio

Study Arms (2)

control group

NO INTERVENTION

No intervention was applied to the control group in this process. * be receiving treatment in Clinic Day Hospital * Volunteering to participate in research

Psychoeducation

EXPERIMENTAL

* be receiving treatment in Clinic Day Hospital * Volunteering to participate in research

Other: Psychoeducation

Interventions

Psychoeducation sessions were conducted by two psychiatric nurses (İK, SS) who are experts in their fields and have psychoeducation and group leadership certificates. Each session was held once a week in 30-45 minutes sessions. The training was carried out interactively; approximately the first 5 minutes were spent on warm-up, the basic information of that day's session was given for 25 minutes, and the last 10 minutes were in the form of questions and answers. Two separate groups were formed according to the day hospital program of the patients, and the psychoeducation program was carried out in two separate groups to conduct psychoeducation effectively.

Psychoeducation

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who were followed up in the psychiatry day hospital,
  • accepted to participate in the study,
  • signed the informed consent form, and were able to read

You may not qualify if:

  • individuals indicating their desire to leave the study,
  • the development of an attack requiring hospitalization,
  • not attending education for more than two sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz Universty Faculty of Nursing

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • Kizilirmak Tatu M, Demir S. Effect of Group Psychoeducation on Treatment Adherence, Quality of Life and Well-Being of Patients Diagnosed with Schizophrenia. Issues Ment Health Nurs. 2021 Mar;42(3):256-266. doi: 10.1080/01612840.2020.1793244. Epub 2020 Aug 12.

Study Officials

  • İlkay Keser

    Akdeniz Universty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the envelope method, 15 envelopes with '1' symbolizing the intervention group and 15 envelopes with '2' symbolizing the control group were found in the box. All individuals pulled envelopes out of the box, and the envelope was not put in the box again. During the psychoeducation process, one patient from the experimental group did not want to continue the training, and one patient from the control group was hospitalized; two patients were excluded from the sample.The pretest evaluation was made in the first interview with the individuals included in the sample. Posttest evaluation was made at the end of the intervention to the individuals in the intervention group. No intervention was applied to the control group in this process. Posttest evaluation was made at the end of the 8th week following the pretest evaluation to the control group. After all evaluations were completed, a single-session informative training was given to the control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a single-blind randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 12, 2021

Study Start

February 15, 2018

Primary Completion

February 15, 2018

Study Completion

May 15, 2018

Last Updated

October 12, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

research can be viewed by all researchers

Shared Documents
STUDY PROTOCOL
Time Frame
ten years
Access Criteria
in search for keywords

Locations