Health Questionnaire Study

February 23, 2026 updated by: Sean D Young, University of California, Irvine

Effects of Emphasizing Instructions on Mental Health Questionnaires

We want to explore if emphasizing certain instructions (i.e. "bothered by") will affect the way participants respond to a questionnaire.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California - Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 or older
  • U.S. resident
  • Self-report being treated for or receiving a diagnosis generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Instruction Emphasis
The second time participants are asked a questionnaire, the study team will emphasize the instructions.
Behavioral: Instruction Emphasis
The study team will emphasize the questionnaire instructions when asking the second time.
No Intervention: Control
Participants will be asked the questionnaire the same way both times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Day 1
9-item questionnaire. Study is completed in 1 day. Scale is administered 2 times. Higher scores mean greater depressive symptoms.
Day 1
Generalized Anxiety Disorder (GAD-7)
Time Frame: Day 1
7-item questionnaire. Study is completed in 1 day. Scale is administered 2 times. Higher scores mean greater anxiety symptoms.
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck's Depression Inventory
Time Frame: Baseline
BDI was collected at baseline as an exploratory measure for convergent validity/correlation analysis, not a primary outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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