Family Members of Psychiatric PatientsNCT07085936
Stress and Stigma Among Psychiatric Caregivers: Effects of a Video-Based Orientation and Feature Importance Via SVR
A study testing Video-based orientation program in people with Family Members of Psychiatric Patients, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention Conducted by: Faculty of Medicine, Karadeniz Technical University (KTU) Purpose of the Study: This study aims to examine the stress and stigma experienced by first-degree relatives (parent… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Members of Psychiatric Patients
- What is being tested?
- Video-based orientation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: First-degree relatives (mother, father, spouse, or child) of patients admitted to the psychiatric inpatient unit
Age 18 years or older
Willing to participate voluntarily
Able to read and write, and to communicate verbally well enough to complete the study instruments -
Exclusion Criteria: Individuals with a current psychiatric diagnosis based on DSM-5 criteria
History of alcohol or substance use
Diagnosed with dementia or other organic mental disorders
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention and Feature Importance Analysis Using SVR
Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention
Conducted by:
Read more
Faculty of Medicine, Karadeniz Technical University (KTU)
Purpose of the Study:
This study aims to examine the stress and stigma experienced by first-degree relatives (parent, spouse, or child) of patients hospitalized in a psychiatric unit, and to evaluate the effect of a video-based orientation training on these experiences.
Where and When Is the Study Conducted? The study will take place in the psychiatric ward of KTU Farabi Hospital between July 15 and September 30, 2025.
Who Can Participate?
You can take part in this study if you are:
A first-degree relative of a psychiatric inpatient,
18 years of age or older,
Able to read, write, and communicate verbally,
Willing to participate voluntarily.
What Will Happen During the Study?
Participants will be randomly assigned to one of two groups:
Intervention group: Will receive video-based orientation training.
Control group: Will receive standard routine orientation.
The video training includes four sessions (each lasting about 45-60 minutes). These sessions cover:
Introduction to the psychiatric unit and the research,
What stigma means and how it affects caregivers,
Basic information about mental illnesses and treatment,
How to understand and cope with stigma.
You will be asked to complete two short questionnaires: one before and one week after the training. These help us understand your stress levels and feelings of stigma.
Confidentiality and Ethics:
This study has been approved by the Scientific Research Ethics Committee of Karadeniz Technical University. All information you provide will be kept confidential and used only for scientific purposes. Your participation is voluntary, and you may withdraw from the study at any time without giving a reason.
Contact Information:
If you would like more information, feel free to contact the research team.
Read the detailed description
Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention and Feature Importance Analysis Using Support Vector Regression
Conducted by:Faculty of Medicine, Karadeniz Technical University (KTU)
Overview and Purpose of the Study:This scientific study is designed to explore the emotional and social challenges faced by family members who care for individuals with mental illness. In particular, it focuses on two common experiences: stress and stigma.
The goal is to assess whether a specially prepared video-based orientation training can help reduce the perceived stress levels and the feelings of being stigmatized among caregivers. By participating in this study, you will contribute to valuable research that can improve future support programs for families like yours.
What Is Stigma and Why Is It Important?"Stigma" refers to the negative beliefs and attitudes that society may hold about mental illness. Unfortunately, these beliefs do not only affect individuals with mental illness-they can also impact their families and caregivers. You may have experienced situations where people judged you or treated you differently because you care for someone with a psychiatric condition. This study aims to help reduce such experiences by offering accurate information, emotional support, and tools for coping.
Study Duration and Location:The study will be conducted between July 15 and September 30, 2025, at the psychiatric ward of KTU Farabi Hospital, located in northeastern Türkiye. This ward is a secure unit where patients with severe psychiatric symptoms receive treatment and support.
Who Can Participate?You are eligible to participate if you:
Are a first-degree relative (mother, father, spouse, or child) of a patient currently hospitalized in the psychiatric unit,
Are 18 years or older,
Can read, write, and communicate verbally,
Volunteer to participate in the study.
Individuals who have a current psychiatric diagnosis themselves or a history of substance use, dementia, or other serious mental conditions will not be included in the study.
What Does Participation Involve?
After agreeing to join the study, you will be randomly placed into one of two groups:
The Intervention Group: You will attend four video-supported orientation sessions.
The Control Group: You will receive routine orientation as typically provided in the hospital.
The video-based training program will be led by mental health professionals and held in a quiet, comfortable room within the psychiatric unit. Each session will last about 45-60 minutes, and will cover the following topics:
Introduction to the psychiatric unit and the research - a video tour and Q\&A session
Understanding stigma - what stigma is, how it affects caregivers, and personal experiences
Basic information about mental illnesses - causes, symptoms, treatment options, and how to provide care
Coping with stigma - strategies and tools to manage emotional and social stress
You will also be asked to fill out two brief questionnaires:
Once before the training (pre-test)
Once one week after the training (post-test) These questionnaires help us evaluate the impact of the training on your stress and stigma levels.
Benefits of Participation:
Gain knowledge and insight about the mental health system and caregiving.
Learn new strategies to cope with emotional challenges and societal stigma.
Contribute to scientific research that may improve mental health care policies and family support services.
Confidentiality and Ethics:This study has been reviewed and approved by the Scientific Research Ethics Committee of Karadeniz Technical University. All the information you provide will be kept strictly confidential and used solely for research purposes. Participation is entirely voluntary, and you are free to withdraw at any time without any consequences.
Contact Information:If you have any questions or would like further details about the study, please feel free to contact the research team. Your questions are always welcome.
We thank you sincerely for considering participation in this important research.
- Conditions
- Family Members of Psychiatric Patients
- Being tested
- Video-based orientation program
- Keywords
- stigma, stress, anxiety
- Medical subject headings
- Social Stigma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based orientation programBehavioural
The intervention group will receive a structured video-based orientation program developed for first-degree relatives of psychiatric inpatients. The program consists of four sessions (each 45-60 minutes) delivered over one week by psychiatric nurses. Topics include an introduction to the psychiatric unit, understanding stigma, basic information on mental illnesses, and strategies for coping with stigma. Educational videos support learning and discussion. Unlike the control group, this intervention emphasizes stigma awareness and emotional support. Pre- and post-tests are used to assess perceived stress and stigma.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | First-degree relatives of psychiatric inpatients who receive a structure Video-based orientation program with four sessions over one week. Sessions cover stigma, mental illness education, and coping strategies, led by psychiatric nurses. Pre- and post-tests assess outcomes. Receives: Behavioral: Video-based orientation program |
| Control group | No intervention | Participants receive standard verbal orientation routinely provided in the hospital, without structured sessions or video materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' Internalized Stigma of Mental Illness Scale (PISMI)
Measured: Baseline (pre-test) and 1 week after intervention (post-test)
Parents' Internalized Stigma of Mental Illness Scale (PISMI)
The PISMI is a 29-item self-report instrument developed by Boyd-Ritsher et al. (2003) to measure internalized stigma in parents of individuals with mental illness. It includes five subscales: Alienation, Stereotype Endorsement, Perceived Discrimination, Social Withdrawal, and Resistance to Stigma. Items are rated on a 4-point Likert scale. Higher scores indicate greater levels of internalized stigma. The Turkish version was adapted by Gül Dikeç et al. (2019).
Measured: Baseline (pre-test) and 1 week after intervention (post-test)
Secondary outcomes (1)
Perceived Stress Scale (PSS-14)
The PSS-14 is a 14-item self-report scale developed by Cohen et al. (1983) to measure the degree to which situations in one's life are appraised as stressful. Scores range from 0 to 56; higher scores indicate higher perceived stress. Turkish version validated by Eskin et al. (2013).
Measured: Baseline (pre-test) and 1 week after intervention (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start15 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Members of Psychiatric PatientsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Aydın, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085936
- Sponsor's protocol ID
- Stigma_Psychiatric Caregivers
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention and Feature Importance Analysis Using SVR
- ClinicalTrials.gov ID
- NCT07085936
- Acronym / sponsor ID
- Stigma_Psychiatric Caregivers
- Conditions
- Family Members of Psychiatric Patients
- Keywords
- stigma, stress, anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jul 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.
Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention
Conducted by:
Faculty of Medicine, Karadeniz Technical University (KTU)
Purpose of the Study:
This study aims to examine the stress and stigma experienced by first-degree relatives (parent, spouse, or child) of patients hospitalized in a psychiatric unit, and to evaluate the effect of a video-based orientation training on these experiences.
Where and When Is the Study Conducted? The study will take place in the psychiatric ward of KTU Farabi Hospital between July 15 and September 30, 2025.
Who Can Participate?
You can take part in this study if you are:
A first-degree relative of a psychiatric inpatient,
18 years of age or older,
Able to read, write, and communicate verbally,
Willing to participate voluntarily.
What Will Happen During the Study?
Participants will be randomly assigned to one of two groups:
Intervention group: Will receive video-based orientation training.
Control group: Will receive standard routine orientation.
The video training includes four sessions (each lasting about 45-60 minutes). These sessions cover:
Introduction to the psychiatric unit and the research,
What stigma means and how it affects caregivers,
Basic information about mental illnesses and treatment,
How to understand and cope with stigma.
You will be asked to complete two short questionnaires: one before and one week after the training. These help us understand your stress levels and feelings of stigma.
Confidentiality and Ethics:
This study has been approved by the Scientific Research Ethics Committee of Karadeniz Technical University. All information you provide will be kept confidential and used only for scientific purposes. Your participation is voluntary, and you may withdraw from the study at any time without giving a reason.
Contact Information:
If you would like more information, feel free to contact the research team.
Detailed description
Determinants of Stress and Stigma Among Caregivers of Psychiatric Patients: The Effect of a Video-Based Orientation Intervention and Feature Importance Analysis Using Support Vector Regression
Conducted by:Faculty of Medicine, Karadeniz Technical University (KTU)
Overview and Purpose of the Study:This scientific study is designed to explore the emotional and social challenges faced by family members who care for individuals with mental illness. In particular, it focuses on two common experiences: stress and stigma.
The goal is to assess whether a specially prepared video-based orientation training can help reduce the perceived stress levels and the feelings of being stigmatized among caregivers. By participating in this study, you will contribute to valuable research that can improve future support programs for families like yours.
What Is Stigma and Why Is It Important?"Stigma" refers to the negative beliefs and attitudes that society may hold about mental illness. Unfortunately, these beliefs do not only affect individuals with mental illness-they can also impact their families and caregivers. You may have experienced situations where people judged you or treated you differently because you care for someone with a psychiatric condition. This study aims to help reduce such experiences by offering accurate information, emotional support, and tools for coping.
Study Duration and Location:The study will be conducted between July 15 and September 30, 2025, at the psychiatric ward of KTU Farabi Hospital, located in northeastern Türkiye. This ward is a secure unit where patients with severe psychiatric symptoms receive treatment and support.
Who Can Participate?You are eligible to participate if you:
Are a first-degree relative (mother, father, spouse, or child) of a patient currently hospitalized in the psychiatric unit,
Are 18 years or older,
Can read, write, and communicate verbally,
Volunteer to participate in the study.
Individuals who have a current psychiatric diagnosis themselves or a history of substance use, dementia, or other serious mental conditions will not be included in the study.
What Does Participation Involve?
After agreeing to join the study, you will be randomly placed into one of two groups:
The Intervention Group: You will attend four video-supported orientation sessions.
The Control Group: You will receive routine orientation as typically provided in the hospital.
The video-based training program will be led by mental health professionals and held in a quiet, comfortable room within the psychiatric unit. Each session will last about 45-60 minutes, and will cover the following topics:
Introduction to the psychiatric unit and the research - a video tour and Q\&A session
Understanding stigma - what stigma is, how it affects caregivers, and personal experiences
Basic information about mental illnesses - causes, symptoms, treatment options, and how to provide care
Coping with stigma - strategies and tools to manage emotional and social stress
You will also be asked to fill out two brief questionnaires:
Once before the training (pre-test)
Once one week after the training (post-test) These questionnaires help us evaluate the impact of the training on your stress and stigma levels.
Benefits of Participation:
Gain knowledge and insight about the mental health system and caregiving.
Learn new strategies to cope with emotional challenges and societal stigma.
Contribute to scientific research that may improve mental health care policies and family support services.
Confidentiality and Ethics:This study has been reviewed and approved by the Scientific Research Ethics Committee of Karadeniz Technical University. All the information you provide will be kept strictly confidential and used solely for research purposes. Participation is entirely voluntary, and you are free to withdraw at any time without any consequences.
Contact Information:If you have any questions or would like further details about the study, please feel free to contact the research team. Your questions are always welcome.
We thank you sincerely for considering participation in this important research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Video-based orientation programFirst-degree relatives of psychiatric inpatients who receive a structure Video-based orientation program with four sessions over one week. Sessions cover stigma, mental illness education, and coping strategies, led by psychiatric nurses. Pre- and post-tests assess outcomes. |
| Control group | No intervention | –Participants receive standard verbal orientation routinely provided in the hospital, without structured sessions or video materials. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Video-based orientation programThe intervention group will receive a structured video-based orientation program developed for first-degree relatives of psychiatric inpatients. The program consists of four sessions (each 45-60 minutes) delivered over one week by psychiatric nurses. Topics include an introduction to the psychiatric unit, understanding stigma, basic information on mental illnesses, and strategies for coping with stigma. Educational videos support learning and discussion. Unlike the control group, this intervention emphasizes stigma awareness and emotional support. Pre- and post-tests are used to assess perceived stress and stigma. | Behavioural | Experimental Group |
Primary outcome
Parents' Internalized Stigma of Mental Illness Scale (PISMI)
Time frame: Baseline (pre-test) and 1 week after intervention (post-test)
Parents' Internalized Stigma of Mental Illness Scale (PISMI)
Time frame: Baseline (pre-test) and 1 week after intervention (post-test)
The PISMI is a 29-item self-report instrument developed by Boyd-Ritsher et al. (2003) to measure internalized stigma in parents of individuals with mental illness. It includes five subscales: Alienation, Stereotype Endorsement, Perceived Discrimination, Social Withdrawal, and Resistance to Stigma. Items are rated on a 4-point Likert scale. Higher scores indicate greater levels of internalized stigma. The Turkish version was adapted by Gül Dikeç et al. (2019).
1 secondary outcome
Perceived Stress Scale (PSS-14)
Time frame: Baseline (pre-test) and 1 week after intervention (post-test)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based orientation program in people with Family Members of Psychiatric Patients, run by Karadeniz Technical 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?
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: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Parents' Internalized Stigma of Mental Illness Scale (PISMI) (time frame: Baseline (pre-test) and 1 week after intervention (post-test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.