Depression, AnxietyNCT06956378
Health Questionnaire Study
A study testing Instruction Emphasis in people with Depression, Anxiety, run by University of California, Irvine at 1 site in United States.
Trial summary
We want to explore if emphasizing certain instructions (i.e. "bothered by") will affect the way participants respond to a questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Instruction Emphasis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - Irvine
Orange, California, 92868
About this study
Official title: 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.
- Conditions
- Depression, Anxiety
- Being tested
- Instruction Emphasis
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction EmphasisBehavioural
The study team will emphasize the questionnaire instructions when asking the second time.
| Study group | Role | What they receive |
|---|---|---|
| Instruction Emphasis | Experimental | The second time participants are asked a questionnaire, the study team will emphasize the instructions. Receives: Behavioral: Instruction Emphasis |
| Control | No intervention | Participants will be asked the questionnaire the same way both times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
9-item questionnaire. Study is completed in 1 day. Scale is administered 2 times. Higher scores mean greater depressive symptoms.
Measured: Day 1
Generalized Anxiety Disorder (GAD-7)
7-item questionnaire. Study is completed in 1 day. Scale is administered 2 times. Higher scores mean greater anxiety symptoms.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start18 Apr 2025
- Primary completion1 Sep 2025
- Study completionMar 2026 (estimated)
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 Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean D Young, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956378
- Sponsor's protocol ID
- 6915
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young SD, Cumberland WG, Fehmie DA, Ugarte D. Instructional Emphasis and PHQ-9 and GAD-7 Scores Among Participants With Anxiety or Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2623952. doi: 10.1001/jamanetworkopen.2026.23952.
PubMed 42475096
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Emphasizing Instructions on Mental Health Questionnaires
- ClinicalTrials.gov ID
- NCT06956378
- Acronym / sponsor ID
- 6915
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 May 2025 (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.
We want to explore if emphasizing certain instructions (i.e. "bothered by") will affect the way participants respond to a questionnaire.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instruction Emphasis | Experimental | Behavioral: Instruction EmphasisThe second time participants are asked a questionnaire, the study team will emphasize the instructions. |
| Control | No intervention | –Participants will be asked the questionnaire the same way both times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 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 |
|---|---|---|
| Instruction EmphasisThe study team will emphasize the questionnaire instructions when asking the second time. | Behavioural | Instruction Emphasis |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 42475096Young SD, Cumberland WG, Fehmie DA, Ugarte D. Instructional Emphasis and PHQ-9 and GAD-7 Scores Among Participants With Anxiety or Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2623952. doi: 10.1001/jamanetworkopen.2026.23952.
- Individual participant dataSharing planned: No
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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 Instruction Emphasis in people with Depression, Anxiety, run by University of California, Irvine at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Health Questionnaire (PHQ-9) (time frame: Day 1). 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 NCT06956378, 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 27 Feb 2026.