Stigma, SocialNCT03907696
Reducing Stigma Towards Psychiatry Among Medical Students
A study testing Anti-stigma interventions curriculum in people with Stigma, Social, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study examines the effect of including a novel Anti-stigma Intervention Curriculum (ASIC) during a clinical rotation in psychiatry during medical school. It addresses stigma in medical students' perceptions of psychiatric patients, psychiatric illnesses and treatments, and the knowledge base of psychiatry in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social
- What is being tested?
- Anti-stigma interventions curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 30 Jul 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All medical students in psychiatric rotation during the academic year of 2017-2018 affiliated to Tel Aviv University
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Stigma Towards Psychiatry Among Medical Students: a Multicenter Controlled Trial
This study examines the effect of including a novel Anti-stigma Intervention Curriculum (ASIC) during a clinical rotation in psychiatry during medical school. It addresses stigma in medical students' perceptions of psychiatric patients, psychiatric illnesses and treatments, and the knowledge base of psychiatry in clinical practice.
Medical students from eight hospitals were divided into intervention (one hospital, n=57) and control (seven hospitals, n=163) arms at the beginning of a 6-week psychiatry rotation throughout one academic year (2017/18). The students completed the Attitudes to Psychiatry scale (ATP-30) and the Attitudes toward Mental Illness scale (AMI) at rotation onset and conclusion. The ASIC was designed to target prejudices and stigma by direct informal encounters with people with severe mental illness (SMI) during periods of remission and recovery. Supervised small group discussions followed those encounters in order to facilitate processing of thoughts and emotions that ensued, and to discuss salient topics, including psychiatric care, evidence-based medicine in psychiatry, and the neuroscientific underpinnings of clinical psychiatry.
Read the detailed description
Design and participants- This study used a controlled trial design. The study population consisted of medical students during their six-week psychiatry clerkship. The study was conducted between November 2017 and July 2018 in eight academic hospitals in central Israel. There were 16 groups of students.
The intervention arm included 3 groups of students (n=57) at a single general hospital, and the control group was comprised of 13 groups of students (n=163) from six psychiatric hospitals (n=139) and one general hospital (n=24). All students were informed that the purpose of the study was to explore their attitudes about people with mental illness and about psychiatry in general at the beginning (baseline) and at the end (endpoint) of their rotation. The participants were assured that their responses would remain confidential, and that they would not influence their rotation grade.
Procedure - The intervention and control groups received the same lecture and practical training components. Topics covered in the lectures included psychopathology, psychopharmacological treatment, psychotherapy, and forensic psychiatry. Practical training included participation in inpatient rounds, visits at outpatient clinics and consultation-liaison services, and seminars consisting of patient interviews and discussions of clinical cases. All students were placed in a psychiatric ward, under the supervision and responsibility of psychiatric residents and senior psychiatrists. Each ward had a range of 4 to 7 students assigned to it. During the rotation, students assumed supervised clinical responsibility for at least one clinical case. Although all students were exposed to a variety of patients in different clinical scenarios, they were exposed mostly to acutely ill inpatients.
Study intervention The Anti-Stigma Interventions Curriculum (ASIC) component that was added to the intervention group was designed to target stigma towards psychiatric patients, psychiatric treatment, and the knowledge base of clinical practice in psychiatry. A first part, aimed at reducing stigma towards psychiatric patients, consisted of two forms of direct encounters with individuals with serious mental illness (SMI) in recovery or rehabilitation: 1) A two-hour panel of three people who shared their personal stories as consumers of mental health services, followed by an open discussion with the students; and 2) A visit to a rehabilitation center, which included direct contact with the consumers. The emphasis in both of those encounters was on exposing students to the competence and strengths of the individuals, rather than to the symptoms and signs of their underlying illnesses. The second part, which was designed to target stigma towards psychiatric treatment and the knowledge base of clinical practice in psychiatry, included small group discussions (20 minutes each) on the efficacy of different treatments, the clinical utility of admission to inpatient wards, evidence-based medicine in psychiatry, and the biological pathways underpinning psychiatric disorders.
The study was conducted after receiving Helsinki ethics committee approval for a multicenter study from the University of Tel Aviv Institutional Review Board. Because the ethics committee approval was contingent on personal information being de-identified, the investigators only used aggregate, unpaired pre- and post-rotation data.
Study evaluations Participants completed one socio-demographic and two self-report questionnaires, the Attitudes to Psychiatry (ATP-30)22, and the Attitudes to Mental Illness (AMI)7, which were administrated through a secured online server (SurveyMonkey®). The ATP-30 consists of 30 items, and it measures medical students' attitudes towards eight different attitudinal domains: 1) Psychiatric patients; 2) Psychiatric illness; 3) Psychiatric treatment; 4) Psychiatric institutions; 5) Psychiatric knowledge base in clinical practice; 6) Psychiatric education; 7) Psychiatry as a career choice; and 8) Psychiatrists. The AMI consists of 20 items, and it measures medical students' attitudes to mental illnesses and, more specifically, towards their causes, treatments, and impact on individuals and society. Each item in both questionnaires is rated on a 5-point Likert scale ranging from strongly agree to strongly disagree. Some items are negatively phrased in order to minimize the likelihood of social desirability bias, and higher composite scores indicate more favorable attitudes (less stigma) toward mental illness. Both ATP-30 and AMI have been shown to have good psychometric properties, and both have been translated into many languages and used in many countries worldwide.7,22
- Conditions
- Stigma, Social
- Being tested
- Anti-stigma interventions curriculum
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-stigma interventions curriculumOther
educational curriculum aimed at reducing stigma
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The intervention arm participate in an educational program that aimed at reducing stigma Receives: Other: Anti-stigma interventions curriculum |
| control | No intervention | regular curriculum with no addition educational contents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude toward psychiatry (ATP) scale
scale that measure stigma among medical students. 30 statements, scale of 1 (strongly disagree) to 5 (strongly agree). Minimum score: 30; maximum score: 150; Higher scores indicate less stigma.
Measured: 6 weeks (psychiatric rotation)
Attitude toward mental illness (AMI) scale
scale that measure stigma among medical students. 30 statements, scale of 1 (strongly disagree) to 5 (strongly agree). Minimum score: 20; maximum score: 100. Higher scores indicate less stigma.
Measured: 6 weeks (psychiatric rotation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Nov 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Raz Gross, Sheba Medical Center
- Investigators
- Doron Amsalem, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907696
- Sponsor's protocol ID
- 4716-17-SMC
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available for other researchers
Publications
Amsalem D, Gothelf D, Dorman A, Goren Y, Tene O, Shelef A, Horowitz I, Dunsky LL, Rogev E, Klein EH, Mekori-Domachevsky E, Fischel T, Levkovitz Y, Martin A, Gross R. Reducing Stigma Toward Psychiatry Among Medical Students: A Multicenter Controlled Trial. Prim Care Companion CNS Disord. 2020 Feb 27;22(2):19m02527. doi: 10.4088/PCC.19m02527.
PubMed 32135042
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stigma Towards Psychiatry Among Medical Students: a Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT03907696
- Acronym / sponsor ID
- 4716-17-SMC
- Conditions
- Stigma, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 9 Apr 2019 (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 study examines the effect of including a novel Anti-stigma Intervention Curriculum (ASIC) during a clinical rotation in psychiatry during medical school. It addresses stigma in medical students' perceptions of psychiatric patients, psychiatric illnesses and treatments, and the knowledge base of psychiatry in clinical practice.
Medical students from eight hospitals were divided into intervention (one hospital, n=57) and control (seven hospitals, n=163) arms at the beginning of a 6-week psychiatry rotation throughout one academic year (2017/18). The students completed the Attitudes to Psychiatry scale (ATP-30) and the Attitudes toward Mental Illness scale (AMI) at rotation onset and conclusion. The ASIC was designed to target prejudices and stigma by direct informal encounters with people with severe mental illness (SMI) during periods of remission and recovery. Supervised small group discussions followed those encounters in order to facilitate processing of thoughts and emotions that ensued, and to discuss salient topics, including psychiatric care, evidence-based medicine in psychiatry, and the neuroscientific underpinnings of clinical psychiatry.
Detailed description
Design and participants- This study used a controlled trial design. The study population consisted of medical students during their six-week psychiatry clerkship. The study was conducted between November 2017 and July 2018 in eight academic hospitals in central Israel. There were 16 groups of students.
The intervention arm included 3 groups of students (n=57) at a single general hospital, and the control group was comprised of 13 groups of students (n=163) from six psychiatric hospitals (n=139) and one general hospital (n=24). All students were informed that the purpose of the study was to explore their attitudes about people with mental illness and about psychiatry in general at the beginning (baseline) and at the end (endpoint) of their rotation. The participants were assured that their responses would remain confidential, and that they would not influence their rotation grade.
Procedure - The intervention and control groups received the same lecture and practical training components. Topics covered in the lectures included psychopathology, psychopharmacological treatment, psychotherapy, and forensic psychiatry. Practical training included participation in inpatient rounds, visits at outpatient clinics and consultation-liaison services, and seminars consisting of patient interviews and discussions of clinical cases. All students were placed in a psychiatric ward, under the supervision and responsibility of psychiatric residents and senior psychiatrists. Each ward had a range of 4 to 7 students assigned to it. During the rotation, students assumed supervised clinical responsibility for at least one clinical case. Although all students were exposed to a variety of patients in different clinical scenarios, they were exposed mostly to acutely ill inpatients.
Study intervention The Anti-Stigma Interventions Curriculum (ASIC) component that was added to the intervention group was designed to target stigma towards psychiatric patients, psychiatric treatment, and the knowledge base of clinical practice in psychiatry. A first part, aimed at reducing stigma towards psychiatric patients, consisted of two forms of direct encounters with individuals with serious mental illness (SMI) in recovery or rehabilitation: 1) A two-hour panel of three people who shared their personal stories as consumers of mental health services, followed by an open discussion with the students; and 2) A visit to a rehabilitation center, which included direct contact with the consumers. The emphasis in both of those encounters was on exposing students to the competence and strengths of the individuals, rather than to the symptoms and signs of their underlying illnesses. The second part, which was designed to target stigma towards psychiatric treatment and the knowledge base of clinical practice in psychiatry, included small group discussions (20 minutes each) on the efficacy of different treatments, the clinical utility of admission to inpatient wards, evidence-based medicine in psychiatry, and the biological pathways underpinning psychiatric disorders.
The study was conducted after receiving Helsinki ethics committee approval for a multicenter study from the University of Tel Aviv Institutional Review Board. Because the ethics committee approval was contingent on personal information being de-identified, the investigators only used aggregate, unpaired pre- and post-rotation data.
Study evaluations Participants completed one socio-demographic and two self-report questionnaires, the Attitudes to Psychiatry (ATP-30)22, and the Attitudes to Mental Illness (AMI)7, which were administrated through a secured online server (SurveyMonkey®). The ATP-30 consists of 30 items, and it measures medical students' attitudes towards eight different attitudinal domains: 1) Psychiatric patients; 2) Psychiatric illness; 3) Psychiatric treatment; 4) Psychiatric institutions; 5) Psychiatric knowledge base in clinical practice; 6) Psychiatric education; 7) Psychiatry as a career choice; and 8) Psychiatrists. The AMI consists of 20 items, and it measures medical students' attitudes to mental illnesses and, more specifically, towards their causes, treatments, and impact on individuals and society. Each item in both questionnaires is rated on a 5-point Likert scale ranging from strongly agree to strongly disagree. Some items are negatively phrased in order to minimize the likelihood of social desirability bias, and higher composite scores indicate more favorable attitudes (less stigma) toward mental illness. Both ATP-30 and AMI have been shown to have good psychometric properties, and both have been translated into many languages and used in many countries worldwide.7,22
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Anti-stigma interventions curriculumThe intervention arm participate in an educational program that aimed at reducing stigma |
| control | No intervention | –regular curriculum with no addition educational contents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All medical students in psychiatric rotation during the academic year of 2017-2018 affiliated to Tel Aviv University
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Anti-stigma interventions curriculumeducational curriculum aimed at reducing stigma | Other | Intervention |
Primary outcome
Attitude toward psychiatry (ATP) scale
Time frame: 6 weeks (psychiatric rotation)
scale that measure stigma among medical students. 30 statements, scale of 1 (strongly disagree) to 5 (strongly agree). Minimum score: 30; maximum score: 150; Higher scores indicate less stigma.
Attitude toward mental illness (AMI) scale
Time frame: 6 weeks (psychiatric rotation)
scale that measure stigma among medical students. 30 statements, scale of 1 (strongly disagree) to 5 (strongly agree). Minimum score: 20; maximum score: 100. Higher scores indicate less stigma.
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 11 Apr 2019.
- Derived from this study: PubMed 32135042Amsalem D, Gothelf D, Dorman A, Goren Y, Tene O, Shelef A, Horowitz I, Dunsky LL, Rogev E, Klein EH, Mekori-Domachevsky E, Fischel T, Levkovitz Y, Martin A, Gross R. Reducing Stigma Toward Psychiatry Among Medical Students: A Multicenter Controlled Trial. Prim Care Companion CNS Disord. 2020 Feb 27;22(2):19m02527. doi: 10.4088/PCC.19m02527.
- Individual participant dataSharing planned: No. Individual participant data is not available for other researchers
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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.
Doron Amsalem, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-stigma interventions curriculum in people with Stigma, Social, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 11 Apr 2019. 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 Israel. 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?
Attitude toward psychiatry (ATP) scale (time frame: 6 weeks (psychiatric rotation)). 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?
On the ClinicalTrials.gov record for NCT03907696, which also lists 1 linked publication.
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 11 Apr 2019.