Instruction Emphasis for Mental Health Surveys

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how emphasizing certain instructions on mental health surveys, such as the phrase "bothered by," might alter responses from individuals with anxiety or depression. The study includes two groups: one will receive special emphasis on instructions when retaking the survey, while the other will not. This trial suits U.S. residents diagnosed or treated for generalized anxiety disorder or major depressive disorder in the past year. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mental health assessments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research has shown that highlighting certain words or phrases in mental health surveys poses no safety risks to participants. This technique, known as "instruction emphasis," examines whether it alters how people respond to questions. It remains safe because it only modifies question presentation, not any medical treatment or procedure.

In studies on mental health surveys, researchers have reported no safety issues, indicating that this method is well-tolerated. Since this trial does not involve testing a new drug or an invasive procedure, the risks remain minimal. Participants can be confident that the focus is on improving survey methods, not on introducing anything that could directly affect their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Instruction Emphasis method because it aims to improve the accuracy of mental health surveys by enhancing how instructions are delivered. Unlike standard surveys where instructions may be overlooked, this approach emphasizes them, potentially leading to more thoughtful and accurate responses. This can significantly impact the reliability of mental health assessments, providing clearer insights into a participant's mental health status. By refining how questions are understood, this method hopes to set a new standard for survey-based mental health diagnostics.

What evidence suggests that emphasizing instructions is effective for mental health surveys?

Research shows that the phrasing of questions in mental health surveys can influence responses. In this trial, participants in the "Instruction Emphasis" arm will receive emphasized instructions when completing the questionnaire a second time. Studies have found that clear instructions reduce mistakes and enhance data accuracy. Clear guidance helps participants focus on their true feelings rather than on socially desirable responses. Additionally, well-designed mental health questionnaires can reliably assess and improve mental health care. When used properly, these questionnaires gather timely and accurate information about mental health symptoms. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing depression, anxiety, major depression, or panic attacks. It's designed to see if the way questions are asked can influence how people respond about their mental health.

Inclusion Criteria

U.S. resident

I have been diagnosed or treated for anxiety or depression by a licensed provider in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete the mental health questionnaire twice, with emphasis on instructions during the second administration for the experimental group

2 weeks

2 visits (virtual)

Follow-up

Participants are monitored for any changes in response patterns after completing the questionnaires

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Instruction Emphasis

Trial Overview The study is testing whether emphasizing certain words in instructions (like 'bothered by') changes responses on a mental health questionnaire. There's no medication involved; it's about survey methodology.

How Is the Trial Designed?

Group I: Instruction Emphasis Experimental Treatment 1 Intervention

The second time participants are asked a questionnaire, the study team will emphasize the instructions.

Group II: Control Active Control 1 Intervention

Participants will be asked the questionnaire the same way both times

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

A study involving 332 grade 9 students showed that using an evidence-based mental health literacy curriculum significantly improved students' knowledge and reduced stigma about mental health, with lasting effects observed one year later.

Both students and educators experienced substantial improvements in mental health knowledge and stigma reduction, indicating that the curriculum is effective for enhancing mental health literacy outcomes in a school setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term impact of a mental health literacy resource applied by regular classroom teachers in a Canadian school cohort. Wei, Y., Church, J., Kutcher, S.[2023]

Outcome research is crucial for assessing the effectiveness of mental health services, but current conditions make it unlikely to be widely implemented in the future.

A new method for estimating clinical improvement using routinely collected data (like treatment duration and termination status) was proposed, highlighting different categories of patient outcomes such as early dropouts and appropriate terminators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of termination status and treatment duration patterns as an indicator of clinical improvement. Pekarik, G.[2019]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

Adverse events in mental health care are common and can lead to significant distress and even death, highlighting the need for improved practices in treatment and discharge processes.

The study identifies critical areas for improvement, including assessment processes, communication, documentation, and training, to reduce the frequency of these adverse events based on coronial recommendations in three Australian States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. Smith-Merry, J., Caple, A.[2014]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The implementation of the Psychiatry Morbidity and Mortality Incident Reporting Tool (PMIRT) led to psychiatrists filing 65 reports over one year, indicating increased engagement in reporting adverse events (AEs).

Following the introduction of PMIRT, the average number of AEs reported in the hospital's formal event reporting system significantly increased, demonstrating that targeted tools can enhance safety reporting practices among psychiatrists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychiatry Morbidity and Mortality Incident Reporting Tool Increases Psychiatrist Participation in Reporting Adverse Events. Kroll, DS., Shellman, AD., Gitlin, DF.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248189/

Developing and studying an outcome-focused measure of ... This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure.

2. sciencedirect.com sciencedirect.com/science/article/pii/S221265702500011X

Systematic review of outcome measures used in evaluation ... This study seeks to identify instruments that have been shown to detect change in child mental health when implemented universally in schools.

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What is a Mental Health Assessment Questionnaire? Unveil the power of the mental health assessment questionnaire! Discover its purpose, benefits, and how to administer for reliable results.

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7 Ways to Use a Mental Health Survey and Questions to Ask Capturing responses at the moment can improve data accuracy by reducing memory errors. Additionally, be aware that social desirability bias can ...

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Measuring and improving the quality of mental health care In this paper, we present a framework for promoting quality measurement as a tool for improving quality of mental health care.

6. withpower.com withpower.com/trial/phase-depressive-disorder-major-3-2025-dd12c

Instruction Emphasis for Mental Health Surveys The research articles focus on tools and methods to detect and report adverse events in mental health care, but they do not provide specific safety data for ...

7. safesupportivelearning.ed.gov safesupportivelearning.ed.gov/sites/default/files/SCIRP/datainttopicalguidementalhlth.pdf

Interpreting Mental Health School Climate Survey Data This Discussion Guide provides suggestions to help you use your school climate data to make meaningful interpretations about the topic of Mental Health ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652438/

Methods, strategies, and incentives to increase response to ... This systematic review aimed to identify effective methods to increase adolescents' response to surveys about mental health and substance use.

9. oklahoma.gov oklahoma.gov/content/dam/ok/en/osde/documents/services/student-development/health-services-resources/Model-Policy-Guidance-SMPH-Rubric.pdf

Student Mental Health Protocol - Oklahoma.gov [District Name] will provide a statement/plan on dissemination of Oklahoma. Prevention Needs Assessment (OPNA) survey data and other mental health data. [ ...

10. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.161.9.1692

Safety Reporting in Randomized Trials of Mental Health ... The authors aimed to evaluate the adequacy of the reporting of safety information in publications of randomized trials of mental-health-related interventions.