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

Primary Purpose

Psychiatric Nursing, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Uncertainty Management Psychoeducation Program
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychiatric Nursing focused on measuring caregiver, nursing theory, uncertainty in illness, psychoeducation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychoeducation Group

Control Group

Arm Description

"Uncertainty Management Psychoeducation Program" was given.

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

Outcomes

Primary Outcome Measures

Intolerance to uncertainty
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.

Secondary Outcome Measures

Perceived uncertainty
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.
Psychological well-being
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.
Coping styles
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.

Full Information

First Posted
March 25, 2021
Last Updated
March 30, 2021
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04822051
Brief Title
The Effect of Psychoeducation Based on Uncertainty In Illness Theory On Schizophrenia Caregivers
Official Title
The Effect of Psychoeducation Based On Uncertainty In Illness Theory On Intolerance To Uncertainty, Psychological Wellbeing And Coping Styles In Schizophrenia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Nursing, Schizophrenia
Keywords
caregiver, nursing theory, uncertainty in illness, psychoeducation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation Group
Arm Type
Experimental
Arm Description
"Uncertainty Management Psychoeducation Program" was given.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No attempt was made by the researcher during the study. Only data collection was carried out.
Intervention Type
Other
Intervention Name(s)
The Uncertainty Management Psychoeducation Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intolerance to uncertainty
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Perceived uncertainty
Description
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.
Time Frame
2 weeks
Title
Psychological well-being
Description
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.
Time Frame
2 weeks
Title
Coping styles
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan Taş Bora
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I do not plan to share any data of participants.
Citations:
PubMed Identifier
15525860
Citation
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.
Results Reference
result
PubMed Identifier
17228986
Citation
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.
Results Reference
result
PubMed Identifier
19819096
Citation
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.
Results Reference
result
PubMed Identifier
23269773
Citation
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.
Results Reference
result
PubMed Identifier
11920549
Citation
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.
Results Reference
result
PubMed Identifier
3203947
Citation
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.
Results Reference
result
PubMed Identifier
2292449
Citation
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.
Results Reference
result
PubMed Identifier
15712339
Citation
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.
Results Reference
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PubMed Identifier
12803150
Citation
Neville KL. Uncertainty in illness. An integrative review. Orthop Nurs. 2003 May-Jun;22(3):206-14. doi: 10.1097/00006416-200305000-00009.
Results Reference
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PubMed Identifier
31928566
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
Williams LA. Theory of caregiving dynamics. In Smith MJ, Liehr PR, eds. Middle Range Theory for Nursing. New York: Springer Publishing Company; 2008.
Results Reference
result

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

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