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

NCT ID: NCT04822051

Last Updated: 2021-04-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychiatric Nursing Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
In this study, it is the same researcher who applied the intervention and evaluated the data.

For this reason, a one-way blinding was made by ensuring that only the individuals who agreed to participate in the study did not know the group they were in.

Study Groups

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Psychoeducation Group

"Uncertainty Management Psychoeducation Program" was given.

Group Type EXPERIMENTAL

The Uncertainty Management Psychoeducation Program

Intervention Type OTHER

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.

Control Group

No attempt was made by the researcher during the study. Only data collection was carried out.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Uncertainty Management Psychoeducation Program

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Sultan TAŞ BORA

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan Taş Bora

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bailey DE, Mishel MH, Belyea M, Stewart JL, Mohler J. Uncertainty intervention for watchful waiting in prostate cancer. Cancer Nurs. 2004 Sep-Oct;27(5):339-46. doi: 10.1097/00002820-200409000-00001.

Reference Type RESULT
PMID: 15525860 (View on PubMed)

Gil KM, Mishel MH, Belyea M, Germino B, Porter LS, Clayton M. Benefits of the uncertainty management intervention for African American and White older breast cancer survivors: 20-month outcomes. Int J Behav Med. 2006;13(4):286-94. doi: 10.1207/s15327558ijbm1304_3.

Reference Type RESULT
PMID: 17228986 (View on PubMed)

Mishel MH, Germino BB, Lin L, Pruthi RS, Wallen EM, Crandell J, Blyler D. Managing uncertainty about treatment decision making in early stage prostate cancer: a randomized clinical trial. Patient Educ Couns. 2009 Dec;77(3):349-59. doi: 10.1016/j.pec.2009.09.009. Epub 2009 Oct 9.

Reference Type RESULT
PMID: 19819096 (View on PubMed)

Germino BB, Mishel MH, Crandell J, Porter L, Blyler D, Jenerette C, Gil KM. Outcomes of an uncertainty management intervention in younger African American and Caucasian breast cancer survivors. Oncol Nurs Forum. 2013 Jan;40(1):82-92. doi: 10.1188/13.ONF.82-92.

Reference Type RESULT
PMID: 23269773 (View on PubMed)

Mishel MH, Belyea M, Germino BB, Stewart JL, Bailey DE Jr, Robertson C, Mohler J. Helping patients with localized prostate carcinoma manage uncertainty and treatment side effects: nurse-delivered psychoeducational intervention over the telephone. Cancer. 2002 Mar 15;94(6):1854-66. doi: 10.1002/cncr.10390.

Reference Type RESULT
PMID: 11920549 (View on PubMed)

Mishel MH. Uncertainty in illness. Image J Nurs Sch. 1988 Winter;20(4):225-32. doi: 10.1111/j.1547-5069.1988.tb00082.x. No abstract available.

Reference Type RESULT
PMID: 3203947 (View on PubMed)

Mishel MH. Reconceptualization of the uncertainty in illness theory. Image J Nurs Sch. 1990 Winter;22(4):256-62. doi: 10.1111/j.1547-5069.1990.tb00225.x.

Reference Type RESULT
PMID: 2292449 (View on PubMed)

Mishel MH, Germino BB, Gil KM, Belyea M, Laney IC, Stewart J, Porter L, Clayton M. Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005 Nov;14(11):962-78. doi: 10.1002/pon.909.

Reference Type RESULT
PMID: 15712339 (View on PubMed)

Neville KL. Uncertainty in illness. An integrative review. Orthop Nurs. 2003 May-Jun;22(3):206-14. doi: 10.1097/00006416-200305000-00009.

Reference Type RESULT
PMID: 12803150 (View on PubMed)

He H, Liu Q, Li N, Guo L, Gao F, Bai L, Gao F, Lyu J. Trends in the incidence and DALYs of schizophrenia at the global, regional and national levels: results from the Global Burden of Disease Study 2017. Epidemiol Psychiatr Sci. 2020 Jan 13;29:e91. doi: 10.1017/S2045796019000891.

Reference Type RESULT
PMID: 31928566 (View on PubMed)

Taş S, Buldukoğlu K. Early period self-care ability and care requirements of schizophrenia patients after discharge. Journal of Psychiatric Nursing. 2018; 9(1):11-22.

Reference Type RESULT

Williams LA. Theory of caregiving dynamics. In Smith MJ, Liehr PR, eds. Middle Range Theory for Nursing. New York: Springer Publishing Company; 2008.

Reference Type RESULT

Other Identifiers

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10386387

Identifier Type: -

Identifier Source: org_study_id

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