NCT06956378

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

April 18, 2025

Last Update Submit

February 23, 2026

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1

Other Outcomes (1)

  • Beck's Depression Inventory

    Baseline

Study Arms (2)

Instruction Emphasis

EXPERIMENTAL

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

Behavioral: Instruction Emphasis

Control

NO INTERVENTION

Participants will be asked the questionnaire the same way both times

Interventions

Instruction EmphasisBEHAVIORAL

The study team will emphasize the questionnaire instructions when asking the second time.

Instruction Emphasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California - Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 4, 2025

Study Start

April 18, 2025

Primary Completion

September 1, 2025

Study Completion

March 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)