The Effect of Psychoeducation Based on Uncertainty In Illness Theory On Schizophrenia Caregivers

March 30, 2021 updated by: Sultan TAŞ BORA, Akdeniz University

The Effect of Psychoeducation Based On Uncertainty In Illness Theory On Intolerance To Uncertainty, Psychological Wellbeing And Coping Styles In Schizophrenia Caregivers

The purpose of this study is to determine the effect of the psychoeducation program based on the Uncertainty in Illness Theory on intolerance to uncertainty, psychological well-being and coping styles of caregivers of schizophrenia patients.

Sample was 54 (experimental group:27; control group: 27) caregivers. Experimental group received psychoeducation program (5 sessions) based on Mishel's Reconceptualized Uncertainty in Illness Theory while control group did not receive any intervention. Data were collected 2 times: pre test, post test.

Study Overview

Detailed Description

It was determined that schizophrenia was seen in 19.78 million people in 2017 and constituted 0.51% of "disability adjusted life years" due to all causes. It has been determined that patients with schizophrenia have care needs in many areas related to daily care such as self-care, relationships and coping even in the early period after discharge. This situation shows that they need support to continue their daily life independently. In this context, families are the closest accessible support elements to the patients. Living with schizophrenia is a difficult situation to deal with for the family as well as for the patient. Caregivers in schizophrenia are dealing with an uncertain future accompanied by hope, fear, or both during the illness process.

Theorist Merle H. Mishel's Uncertainty in Illness Theory (UIT) emerged within the framework of the concept of "uncertainty in illness". The Reconceptualized Uncertainty in Illness Theory (RUIT) was developed to explain chronic conditions that cause individuals to experience uncertainty. "Uncertainty in illness" arises when disease-related processes have characteristics such as complexity, inconsistency, unpredictability, and lack of knowledge. RUIT provides a framework for nurses to develop interventions to improve psychological and behavioral outcomes that occur under uncertainty.Interventions for managing uncertainty help individuals gain knowledge, solve problems, see their health conditions manageable, and improve communication and coping skills. When RUIT based interventions are applied to cancer patients, many positive results have been reported in psychosocial aspects, especially in managing uncertainty.

This study that randomized controlled single blinded experimental nature, was conducted between April 2019 and August 2020 at psychiatry clinic with hospitalized schizophrenia patients caregivers, total of 54 including 27 interventions and 27 control groups. The data were collected by "Caregiver Information Form, Visual Analogue Scale, Intolerance to Uncertainty Scale, Psychological Well-being Scale, Stress Coping Styles Scale". The Uncertainty Management Psychoeducation Program, consisting of a total of five sessions was applied to the intervention group. No intervention was applied to the caregivers in the control group. The psychoeducational intervention, which was individually designed consisting of one session per day for each caregiver and five sessions with a gap of at least two days between sessions, was completed within two weeks. Pre-test and post-test measurements were also carried out during this period, and scales were applied for the pre-test at the beginning of the first session and for the post-test at the end of the last session. Mann-Whitney U and Wilcoxon tests were used for hypotheses.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being primarily responsible for the care of the patient diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • For caregiver; being above 18 years of age
  • Being literate
  • For patient; being over 18 years of age
  • Being diagnosed with schizophrenia for at least a year

Exclusion Criteria:

  • Having any physical (hearing, speech, etc.) or mental disorder (psychotic disorder, mental retardation, etc.)
  • Being a participant in a similar research
  • For patient; having other accompanying mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychoeducation Group
"Uncertainty Management Psychoeducation Program" was given.
The program is conducted in the form of individual psychoeducation. The training was planned to include a total of five sessions, with 60 minutes for each session once a day, and at least two sessions a week. At least two days of a gap was decided between two consecutive sessions.
No Intervention: Control Group
No attempt was made by the researcher during the study. Only data collection was carried out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intolerance to uncertainty
Time Frame: 2 weeks
Intolerance to Uncertainty Scale, consisting of 12 items. Intolerance to uncertainty is defined as "the tendency to react negatively to uncertain events and situations in cognitive, affective and behavioral terms Higher scores indicate a high level of intolerance to uncertainty. The highest score that can be obtained from the scale is 60 and the lowest score is 12.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived uncertainty
Time Frame: 2 weeks

Visual analogue scale (VAS) is a scale used to convert some values that cannot be measured numerically into numerical ones. The two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line in the scale and one is asked to indicate where his condition is appropriate on this line. In the evaluation of the test, the values obtained for the individuals are averaged.

VAS, was used to measure the level of uncertainty perceived by the individuals in this study. It is arranged in such a way that the level of uncertainty perceived by the caregiver can be marked on a ten-centimeter ruler with "no uncertainty" at the left end and "a high level of uncertainty" at the right. The lowest score that can be obtained from the scale is 0, the highest score is 10. 10 points indicates that the perceived level of uncertainty is too high.

2 weeks
Psychological well-being
Time Frame: 2 weeks
Psychological Well-being Scale The scale has a single dimension and consists of 8 items. The items of the Psychological Well-Being Scale are answered between 1 and 7 as strongly disagree (1) and strongly agree (7). All items in the scale are expressed positively. Scores range from 8 (if all items are answered "strongly disagree") to 56 (if all items are answered "strongly agree"). A high score indicates that the person has psychological resources and strength.
2 weeks
Coping styles
Time Frame: 2 weeks
Ways of Coping Questionnaire Scale measures two main styles of coping with stress. These are "Problem-oriented / active" and "Emotional / passive" styles. Higher scores obtained from self-confident, optimistic, and social support-seeking approaches mean that the person uses effective or active coping strategies, and higher scores from helpless and submissive approach scores mean that ineffective passive coping strategies are used. The scale is a 4-point Likert type consisting of 30 items and 5 separate subscales. Each item - totally unsuitable 0 points - unsuitable 1 point - suitable 2 points - totally appropriate 3 points. In the scale, the scores of each subscale are calculated separately and the total score for that subscale is obtained. 0-21 points for Self-Confident Approach, 0-24 points for Optimistic Approach, 0-15 points for the Social Support Seeking Approach, 0-12 points for Insecure Approach, 0-18 points for Submissive Approach.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sultan Taş Bora, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 28, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

I do not plan to share any data of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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