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CompletedNCT06850441Updated Apr 28, 2026

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

An interventional study of Psychoeducation in Diabetes Mellitus, Type I, Stigma and Quality of Life (QOL), sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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

Researchers will compare the group that did not receive stigma prevention psychoeducation with those that did.

Participants will receive 7 sessions of the psychoeducation once a week. An evaluation session will be administered 3 months after the psychoeducation.

Researchers will assess all participants' stigma and quality of life before, after and 3 months after the psychoeducation.

Read the detailed description

Individuals who were diagnosed with Type 1 Diabetes at least 6 months ago, are between the ages of 18-75, and can speak and understand the language spoken will be included in the study. Individuals with hearing and visual impairments and those diagnosed with mental retardation will not be included in the study. Participants will be assigned to the intervention and control groups by the statistician through randomization. Each group will consist of 18 people.

Stigma prevention psychoeducation will be applied to the intervention group. This psychoeducation will be conducted as a group education. No intervention will be applied to the control group.

The researcher will evaluate the stigma and quality of life of the intervention and control groups before, after and 3 months after the education. pre-test and post-test and 3-month follow-up Group psychoeducation will be applied to the participants in the intervention group once a week. After the education, they will be evaluated according to the nursing outcome criteria

02

Conditions studied

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

Keywords

  • Diabetes Mellitus, Type I
  • Stigma
  • Quality of life
  • Roy Adaptation Model
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 36 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Having hearing and vision impairment
  • Being diagnosed with mental retardation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Psychoeducation Group

    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

  • No intervention
    Control Group

    No intervention

Interventions

  • OtherPsychoeducation

    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.

06

What researchers measure

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.

    Time frame: 0 day, 7 weeks, 3 months

Secondary outcomes

  1. Short Form-36

    Short Form-36 is a scale that evaluates quality of life in terms of physical and mental health. It was developed by Ware and his colleagues (Ware and Sherbourne, 1992). It consists of 36 items and 8 sub-dimensions; Physical function, physical role, pain, general health perception, vitality, social function, mental role and mental health. The 4th and 5th items of the assessment are yes/no and the rest are Likert type. The sub-dimensions are scored, not the whole scale. The scoring of the sub-scales varies between 0 and 100. A high score indicates a better level of health, while a low score indicates deterioration in health.

    Time frame: 0 day, 7 weeks, 3 months

07

Study locations

1 site
  • Ege University
    Izmir, Bornova 35040, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 1593914 ↗
  • 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. PubMed 28891210 ↗
  • 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. PubMed 36685628 ↗

Individual participant data

Plan to share: No — This experimental study is a thesis study. In order to preserve originality, I do not approve of sharing it.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06850441
Lead sponsor
Izmir Katip Celebi University
Responsible party
Ece MUTLU SATIL (Research Assistant, Izmir Katip Celebi University) — Principal investigator
First posted
Feb 27, 2025
Start date
Jul 1, 2024
Primary completion
Feb 17, 2025
Completion
Feb 28, 2025
Last update
Apr 28, 2026

Study contacts

Seyda Dülgerler, PhD
study chair · Ege University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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