The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers

NCT ID: NCT05068765

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the effectiveness of a communication skills-focused psychoeducation program on the subjective well-being of primary caregivers of individuals with schizophrenia.

Today, with the adoption of contemporary treatment models, the relatives of individuals with schizophrenia have become caregivers. Some caregivers who are not competent enough to communicate satisfactorily with a person diagnosed with schizophrenia may have problems in patient-patient-relative interaction. Problems that occur frequently in expressing oneself, giving appropriate reactions in interaction with the patient and creating a sense of trust are seen as a major source of concern by caregivers. In the solution of this problem, improving the communication skills of the caregiver and increasing the self-confidence and motivation to communicate with the individual diagnosed with schizophrenia is an area that should be addressed by mental health professionals.

By using a communication skills focused psychoeducation program, it is aimed to increase the level of subjective well-being of caregivers of individuals with schizophrenia by establishing healthy and positive relationships, coping with the negative emotions and difficulties they face, realizing their strengths, and leading a happy and meaningful life. Within the scope of this aim, it was aimed to evaluate the effect of a communication skills focused psychoeducation program on the subjective well-being of caregivers of individuals with schizophrenia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was planned as an experimental study with a randomized control group in order to evaluate the effect of psychoeducation focused on communication skills on the subjective well-being of caregivers of individuals with schizophrenia.

The population of the research will be family members who apply to ZBEÜ Application and Research Center Psychiatry Outpatient Clinic and care for individuals diagnosed with schizophrenia according to DSM-5 TR criteria. Statistical power analysis was applied for the number of samples. While calculating the power values, the results were determined within the scope of 95% confidence level. According to the power values obtained from the reference study in parallel with the research to be carried out, if this study is studied with a total of 60 observations, a test power of approximately 88.5% is reached. As a result, according to the power analysis, it was determined that the research could be done with 60 observations. The caregiver family members included in the study will be stratified according to the scores they get from the care burden and communication skills scale and some individual characteristics, and an equal number of individuals from each stratum will be selected, and they will be included in two intervention groups and a control group by randomization.

The Criteria for Inclusion of Caregivers in the Research are as follows:

* The patient receiving care should have been diagnosed with schizophrenia at least one year ago according to the DSM-V TR diagnostic criteria,
* Living together with the caregiver for at least six months,
* Being directly (fully) responsible for the care of the patient being cared for,
* Being 18 years or older,
* Residing in the city center of Zonguldak,
* To be at least primary school graduate,
* No hearing and comprehension problems. The first measurements (Information Form, Zarit Care Burden Scale, Subjective Well-Being Scale and Communication Skills Scale) will be collected by making face-to-face preliminary interviews with the caregivers who meet the research criteria and agree to participate in the research.

After the pre-test, intervention and control groups will be formed in line with homogeneity in terms of scale scores and some individual characteristics.

While the control group continues their routine follow-ups, psychoeducation focused on communication skills will be applied to the first intervention group and general psychoeducation program to the second intervention group.

After the psychoeducation program is completed, final measurements will be collected for intervention and control groups. Follow-up measurements will be made in the intervention and control groups in the 1st and 3rd months.

The first intervention group will be given a communication skills-focused psychoeducation program for eight weeks, one session per week, for a total of eight sessions. The number of sessions was planned with reference to the study in which the effect of the psychoeducation program on general health and communication skills in caregivers of individuals with schizophrenia was investigated. The second intervention group will be given a general psychoeducation program for four weeks, one session per week, in total. Session groups will be formed from a single session of 60-90 minutes for each topic.

Scales Subjective well-being scale: The scale is a five-point Likert type consisting of 46 items. The aim of the scale is to determine the subjective well-being levels of individuals by determining the frequency and intensity of positive and negative emotions with their cognitive evaluations of their lives. Subjective well-being scale consists of personal judgments and positive and negative emotional expressions about living spaces. The lowest score that can be obtained from the scale is 46, and the highest score is 230. A high score indicates a high level of subjective well-being.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Caregiver Psychoeducation Communication Skills Well-being

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months.

Group Type NO_INTERVENTION

No interventions assigned to this group

communication skills psychoeducation

Communication skills focused psychoeducation group will be given a communication skills-focused psychoeducation program for eight weeks, one session per week, for a total of eight sessions. The number of sessions was planned with reference to the study in which the effect of the psychoeducation program on general health and communication skills in caregivers of individuals with schizophrenia was investigated.Session groups will be formed from a single session of 60-90 minutes for each topic.

Group Type EXPERIMENTAL

Communication skills psychoeducation

Intervention Type OTHER

Intervention explanations are explained in the groups section.

general psychoeducation

General psychoeducation group will be given a general psychoeducation program for four weeks, one session per week, in total. Session groups will be formed from a single session of 60-90 minutes for each topic.

Group Type EXPERIMENTAL

General psychoeducation

Intervention Type OTHER

İntervention descriptions are explained in the intervention groups section.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Communication skills psychoeducation

Intervention explanations are explained in the groups section.

Intervention Type OTHER

General psychoeducation

İntervention descriptions are explained in the intervention groups section.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient receiving care has a diagnosis of schizophrenia,
* Living with the patient receiving care for 6 months,
* Being directly (full) responsible for the care of the patient being cared for,
* Be over 18 years old,
* Living in the city center of Zonguldak,
* To be at least primary school graduate,
* Having no hearing and comprehension problems,

Exclusion Criteria

• Having a history of substance abuse (excluding nicotine)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ŞİRİN HARKİN

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ŞİRİN HARKİN

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hülya Bilgin, Prof.

Role: STUDY_DIRECTOR

Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty Mental Health and Psychiatric Nursing Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zonguldak Bulent Ecevit University Health Practice and Research Hospital

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Gharavi Y, Stringer B, Hoogendoorn A, Boogaarts J, Van Raaij B, Van Meijel B. Evaluation of an interaction-skills training for reducing the burden of family caregivers of patients with severe mental illness: a pre-posttest design. BMC Psychiatry. 2018 Mar 27;18(1):84. doi: 10.1186/s12888-018-1669-z.

Reference Type BACKGROUND
PMID: 29587690 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.1016/j.ejpsy.2018.04.001

Rezaei, et al. (2018). Applying psychoeducational program on general health and communication skills in caregivers of patients with schizophrenia: a randomized controlled trial. The European Journal of Psychiatry, 32(4), 174-181

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

157435

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TTM-Based Social Media Psychoeducation for Psychosis
NCT07080827 ACTIVE_NOT_RECRUITING NA