AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Israel1 site
  • Doron Amsalem

    Tel Aviv, 6432633

Other trials in Israel

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 groups in NCT03907696
Study groupRoleWhat they receive
InterventionOtherThe intervention arm participate in an educational program that aimed at reducing stigma
Receives: Other: Anti-stigma interventions curriculum
controlNo interventionregular curriculum with no addition educational contents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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.

  1. First posted9 Apr 2019
  2. Study start1 Nov 2017
  3. Primary completion30 Jul 2018
  4. Study completion30 Jul 2018

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in