Depression LiteracyNCT02663180
Effects of an Educational Program on Depression Literacy and Stigma Among Secondary School Students in Jazan City
A study testing Educational program and Video contact in people with Depression Literacy and Depression Stigma, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Depression is a serious mental health disease. It is generally characterized by sadness, loss of interest in activities, and decreased energy. Globally, it is estimated that almost 350 million people suffer from depression. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Literacy, Depression Stigma
- What is being tested?
- Educational program and Video contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2016to Apr 2016
- 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students needed to be enrolled in one of the selected schools during the academic year 2015-2016.
- Must be in the age group 10-19 years.
- Must agree to participate in the study (consent was obtained from the students,and proxy consent was obtained from guardians).
- Exclusion Criteria There were no exclusion criteria for participation in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Educational Program on Depression Literacy and Stigma Among Students of Secondary Schools in Jazan City
Depression is a serious mental health disease. It is generally characterized by sadness, loss of interest in activities, and decreased energy. Globally, it is estimated that almost 350 million people suffer from depression. In Saudi Arabia, literature suggested that prevalence of depression among boy's secondary school students in Abha city was 38.2%. Another study found that the prevalence of depression was 22.4 % as moderate, 7.3 % as severe and 3.7% as very severe, with a clear predominance prevalence of depression in girls as in boys (1.5 times). It is important to assess depression literacy including knowledge and beliefs about mental disorders among adolescent. A high level of mental health literacy on depression leads to a better understanding and outcomes of depressive disorders. Schools are a typical venue in which to embed mental health literacy because the school students are more familiar with educational activities. Studies concluded that educational intervention about depression literacy and destigmatization improves knowledge and may decrease stigma. Further research, intervention and activism are needed in the field of mental health in Arab countries to improve awareness of mental health problems.
Objectives: This study is aimed to measure the effect of educational intervention program about depression among secondary schools in Jazan city on depression literacy and stigma during the academic year 2015-2016.
Read more
The intervention: the intervention will held at each selected intervention school separately. The program will be over 2 weeks intervention as the following:
- Educational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools.
- Contact strategies: the investigators will show a video of a young male who had been diagnosed (i.e., not an actor) with depression.
Benefits:
- The intervention group will join educational intervention program they expected to benefit from the program through increase their depression literacy and improve depression stigma, and control group will not join any form of intervention.
Risk: There is no expected risk for participating in the study.
Consent: Three Informed Consents forms will be signed from students, guardians and school manager.
- Conditions
- Depression Literacy, Depression Stigma
- Being tested
- Educational program, Video contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
Educational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools.
Video contactBehavioural
Contact strategies: Investigators will show a video of a young male who had been diagnosed with depression. The video presented information that was moderately disconfirming of prior stereotypes by balancing the individual's difficulties resulting from Depression, with his ability to live a normal life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | they will be enrolled in an educational program and video contact. Receives: Behavioral: Educational program; Behavioral: Video contact |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Literacy measured by Depression Literacy Questionnaire (D-Lit)
is measured by Depression Literacy Questionnaire (D-Lit)
Measured: is measured at baseline, directly after the intervention and three months follow-up.
Secondary outcomes (2)
Change in Depression Stigma measured by Depression Stigma Scale (DSS)
is measured by Depression Stigma Scale (DSS)
Measured: is measured at baseline, directly after the intervention and three months follow-up.
Change in Depression Self-Stigma measured by Self Stigma of Depression Scale (SSDS)
is measured by Self Stigma of Depression Scale (SSDS)
Measured: is measured at baseline, directly after the intervention and three months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression LiteracyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Collaborators
- Saudi Board of Community Medicine
- Responsible party
- Principal investigator, Hussain Darraj, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663180
- Sponsor's protocol ID
- U1111-1179-1857
- Status last verified
- Oct 2020
- First submitted
- 19 Jan 2016
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Educational Program on Depression Literacy and Stigma Among Students of Secondary Schools in Jazan City
- ClinicalTrials.gov ID
- NCT02663180
- Acronym / sponsor ID
- U1111-1179-1857
- Conditions
- Depression Literacy, Depression Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of JazanOther government
- Collaborators
- Saudi Board of Community Medicine
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Depression is a serious mental health disease. It is generally characterized by sadness, loss of interest in activities, and decreased energy. Globally, it is estimated that almost 350 million people suffer from depression. In Saudi Arabia, literature suggested that prevalence of depression among boy's secondary school students in Abha city was 38.2%. Another study found that the prevalence of depression was 22.4 % as moderate, 7.3 % as severe and 3.7% as very severe, with a clear predominance prevalence of depression in girls as in boys (1.5 times). It is important to assess depression literacy including knowledge and beliefs about mental disorders among adolescent. A high level of mental health literacy on depression leads to a better understanding and outcomes of depressive disorders. Schools are a typical venue in which to embed mental health literacy because the school students are more familiar with educational activities. Studies concluded that educational intervention about depression literacy and destigmatization improves knowledge and may decrease stigma. Further research, intervention and activism are needed in the field of mental health in Arab countries to improve awareness of mental health problems.
Objectives: This study is aimed to measure the effect of educational intervention program about depression among secondary schools in Jazan city on depression literacy and stigma during the academic year 2015-2016.
The intervention: the intervention will held at each selected intervention school separately. The program will be over 2 weeks intervention as the following:
- Educational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools.
- Contact strategies: the investigators will show a video of a young male who had been diagnosed (i.e., not an actor) with depression.
Benefits:
- The intervention group will join educational intervention program they expected to benefit from the program through increase their depression literacy and improve depression stigma, and control group will not join any form of intervention.
Risk: There is no expected risk for participating in the study.
Consent: Three Informed Consents forms will be signed from students, guardians and school manager.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Educational program, Behavioral: Video contactthey will be enrolled in an educational program and video contact. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Students needed to be enrolled in one of the selected schools during the academic year 2015-2016.
- Must be in the age group 10-19 years.
- Must agree to participate in the study (consent was obtained from the students,and proxy consent was obtained from guardians).
- Exclusion Criteria There were no exclusion criteria for participation in this study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational programEducational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools. | Behavioural | Intervention group |
| Video contactContact strategies: Investigators will show a video of a young male who had been diagnosed with depression. The video presented information that was moderately disconfirming of prior stereotypes by balancing the individual's difficulties resulting from Depression, with his ability to live a normal life. | Behavioural | Intervention group |
Primary outcome
Change in Depression Literacy measured by Depression Literacy Questionnaire (D-Lit)
Time frame: is measured at baseline, directly after the intervention and three months follow-up.
is measured by Depression Literacy Questionnaire (D-Lit)
2 secondary outcomes
Change in Depression Stigma measured by Depression Stigma Scale (DSS)
Time frame: is measured at baseline, directly after the intervention and three months follow-up.
Change in Depression Self-Stigma measured by Self Stigma of Depression Scale (SSDS)
Time frame: is measured at baseline, directly after the intervention and three months follow-up.
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 Oct 2020.
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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 Educational program and Video contact in people with Depression Literacy and Depression Stigma, run by University of Jazan at 1 site in Saudi Arabia.
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 4 inclusion and 0 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 Oct 2020. 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 Saudi Arabia. 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?
Change in Depression Literacy measured by Depression Literacy Questionnaire (D-Lit) (time frame: is measured at baseline, directly after the intervention and three months follow-up.). 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 28 Oct 2020.