Effects of Education on Stigma and Quality of Life in Individuals With Type 1 Diabetes

NCT06850441 | Completed

• 1 other identifier: IzmirKCU-SBF-EMS-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aimed to examine the effects of anti-stigma psychoeducation based on the Roy Adaptation Model on stigma and quality of life in individuals with Type 1 Diabetes.The main questions it aims to answer are:

1. 1.Does anti-stigma psychoeducation reduce stigma of individuals diagnosed with Type 1 Diabetes?
2. 2.Does anti-stigma psychoeducation improve the quality of life of individuals diagnosed with Type 1 Diabetes?

Conditions

Diabetes Mellitus, Type I; Stigma; Quality of Life (QOL)

Keywords

Diabetes Mellitus, Type I; Stigma; Quality of life; Roy Adaptation Model

Outcome Measures

Primary Outcomes (1)

• Type 1 Diabetes Stigma Assessment Scale

  Type 1 Diabetes Stigma Assessment Scale was developed by Browne et al. in 2017 to assess perceived and experienced stigma in adults diagnosed with type 1 diabetes. The scale consists of 19 items. The scale has 3 sub-dimensions; "treated differently", "Blame and judgment" and "Identity concerns" Each item is scored on a 5-point Likert scale. (1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree). Item scores are added to obtain the sub-dimensions and total score of the scale. A high score indicates an increase in perceived and felt stigma.

  0 day, 7 weeks, 3 months

Secondary Outcomes (1)

• Short Form-36

  0 day, 7 weeks, 3 months

Study Arms (2)

Psychoeducation Group

EXPERIMENTAL

The education is a group psychoeducation. Education methods such as role-play, discussion, demonstration, and narration will be applied. The education will be held once a week and will be completed in 7 weeks. Psychoeducation topics include adaptation to stigma in type 1 diabetes, coping, diabetes management, social life, self-esteem, roles in life and impact on life. Concepts such as stigma, blame, judgment, discrimination, shame and stereotyped thoughts will be included.

Other: Psychoeducation

Control Group

NO INTERVENTION

No intervention

Interventions

Psychoeducation OTHER

The education is a group psychoeducation. Education methods such as role-play, discussion, demonstration, and narration will be applied. The education will be held once a week and will be completed in 7 weeks. Psychoeducation topics include adaptation to stigma in type 1 diabetes, coping, diabetes management, social life, self-esteem, roles in life and impact on life. Concepts such as stigma, blame, judgment, discrimination, shame and stereotyped thoughts will be included.

Psychoeducation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Type 1 diabetes at least 6 months ago,
• Being between the ages of 18 and 75,
• Speaking and understanding Turkish,

You may not qualify if:

• Having hearing and vision impairment
• Being diagnosed with mental retardation

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (3)

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 RESULT

• Browne JL, Ventura AD, Mosely K, Speight J. Measuring Type 1 diabetes stigma: development and validation of the Type 1 Diabetes Stigma Assessment Scale (DSAS-1). Diabet Med. 2017 Dec;34(12):1773-1782. doi: 10.1111/dme.13507.

  PMID: 28891210 RESULT

• Satil EM, Arabaci LB. Turkish validity and reliability of Type-1 Diabetes Stigma Assessment Scale. North Clin Istanb. 2022 Dec 12;9(6):654-662. doi: 10.14744/nci.2021.36937. eCollection 2022.

  PMID: 36685628 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Social Stigma

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Seyda Dülgerler, PhD

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A diabetes education nurse will identify participants and assign numbers to the identified participants. A statistician will randomize the participant numbers. A different nurse will place the participants in the experimental and control groups according to the numbers. A statistician will evaluate the results of the education. Thus, the researcher will be blinded in both the participant selection and the outcome evaluation stages.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Intervention group to be given group psychoeducation The control group to continue their routine treatments and not receive intervention

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: July 1, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 28, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)