NCT06774573

Brief Summary

The purpose of the proposed study is to test the feasibility and efficacy of a "anxiety-focused" text-delivered counseling program to reduce anxiety symptoms among young adults (18-25) with elevated anxiety symptoms. We are primarily interested in whether the intervention will reduce anxiety. We have adapted an effective in-person, manualized cognitive behavioral therapy treatment for anxiety (Muñoz et al, 2000) into an 8-week, text-delivered anxiety treatment, named CBT-txt-Anxiety. We will test this with 100 young adults who will be randomized to either CBTtxt-Anxiety or waitlist control condition and assessed at baseline, and at 1- month, 2-months, and 3-months post-baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

January 8, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

anxiety, young adult, text-message treatment

Outcome Measures

Primary Outcomes (1)

  • GAD-7

    Generalized Anxiety Disorder Symptoms

    baseline, 1, 2, and 3 months post-basseline

Study Arms (2)

CBT-txt-A

EXPERIMENTAL

8-week automated text-message delivered treatment for Generalized Anxiety Disorder

Behavioral: CBT-txt-A

Control

NO INTERVENTION

Assessment only condition

Interventions

CBT-txt-ABEHAVIORAL

8-week automated text-message delivered treatment for Generalized Anxiety Disorder

CBT-txt-A

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A) 18 to 25 years old B) a score of at least 10 on the GAD-7 (indicating elevated anxiety symptoms) C) lives in the United States D) consents to receiving text messages from the study

You may not qualify if:

  • A) treatment for anxiety during the past three months B) lack of access to a text-capable phone C) unable or unwilling to commit to three months of follow-up D) not fluent in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee-Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two group randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

December 18, 2024

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations