NCT04822051

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

March 25, 2021

Last Update Submit

March 30, 2021

Conditions

Keywords

caregivernursing theoryuncertainty in illnesspsychoeducation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (3)

  • Perceived uncertainty

    2 weeks

  • Psychological well-being

    2 weeks

  • Coping styles

    2 weeks

Study Arms (2)

Psychoeducation Group

EXPERIMENTAL

"Uncertainty Management Psychoeducation Program" was given.

Other: The Uncertainty Management Psychoeducation Program

Control Group

NO INTERVENTION

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

Interventions

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.

Psychoeducation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

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

    RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sultan Taş Bora

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

April 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

I do not plan to share any data of participants.

Locations