Diabetes Mellitus, Type INCT06850441
Effects of Education on Stigma and Quality of Life in Individuals With Type 1 Diabetes
A study testing Psychoeducation in people with Diabetes Mellitus, Type I and Stigma, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type I, Stigma, Quality of Life (QOL)
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 diabetes at least 6 months ago,
- Being between the ages of 18 and 75,
- Speaking and understanding Turkish,
Who cannot join
- Having hearing and vision impairment
- Being diagnosed with mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anti-Stigma Psychoeducation Based on Roy Adaptation Model 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:
- Does anti-stigma psychoeducation reduce stigma of individuals diagnosed with Type 1 Diabetes?
- Does anti-stigma psychoeducation improve the quality of life of individuals diagnosed with Type 1 Diabetes?
Read more
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
- Conditions
- Diabetes Mellitus, Type I, Stigma, Quality of Life (QOL)
- Being tested
- Psychoeducation
- Keywords
- Diabetes Mellitus, Type I, Stigma, Quality of life, Roy Adaptation Model
- Medical subject headings
- Diabetes Mellitus, Type 1, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychoeducation |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 day, 7 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jul 2024
- Primary completion17 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group to be given group psychoeducation The control group to continue their routine treatments and not receive intervention
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece MUTLU SATIL, Izmir Katip Celebi University
- Investigators
- Seyda Dülgerler, PhD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850441
- Sponsor's protocol ID
- IzmirKCU-SBF-EMS-001
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This experimental study is a thesis study. In order to preserve originality, I do not approve of sharing it.
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 1593914Browne 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 28891210Satil 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-Stigma Psychoeducation Based on Roy Adaptation Model on Stigma and Quality of Life in Individuals With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06850441
- Acronym / sponsor ID
- IzmirKCU-SBF-EMS-001
- Conditions
- Diabetes Mellitus, Type I, Stigma, Quality of Life (QOL)
- Keywords
- Diabetes Mellitus, Type I, Stigma, Quality of life, Roy Adaptation Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does anti-stigma psychoeducation reduce stigma of individuals diagnosed with Type 1 Diabetes?
- 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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group to be given group psychoeducation The control group to continue their routine treatments and not receive intervention
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Group | Experimental | Other: PsychoeducationThe 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. |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Type 1 diabetes at least 6 months ago,
- Being between the ages of 18 and 75,
- Speaking and understanding Turkish,
Key exclusion criteria (2 listed)
- Having hearing and vision impairment
- Being diagnosed with mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationThe 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 Group |
Primary outcome
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.
1 secondary outcome
Short Form-36
Time frame: 0 day, 7 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 1593914Ware 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.
- Results publication: PubMed 28891210Browne 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.
- Results publication: PubMed 36685628Satil 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.
- Individual participant dataSharing planned: No. This experimental study is a thesis study. In order to preserve originality, I do not approve of sharing it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Dülgerler, PhD study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Diabetes Mellitus, Type I and Stigma, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 1 Diabetes Stigma Assessment Scale (time frame: 0 day, 7 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850441, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.