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NCT Number: NCT06850441

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

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.

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Key information

Conditions

Diabetes Mellitus, Type I Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life (QOL) Social Behavior Social Stigma Stigma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. Type 1 Diabetes Stigma Assessment Scale

    Time frame: 0 day, 7 weeks, 3 months

    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.

Secondary outcomes

  1. Short Form-36

    Time frame: 0 day, 7 weeks, 3 months

    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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Effects of Anti-Stigma Psychoeducation Based on Roy Adaptation Model on Stigma and Quality of Life in Individuals With Type 1 Diabetes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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