Recruiting

Safety Behavior Fading

Sponsor:

Florida State University

Code:

NCT07391020

Conditions

Generalized Anxiety Disorder (GAD)

Worrying

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Safety Behavior Fading for Pathological Worry

Progressive Muscle Relaxation (PMR)

Study Details

Brief summary:

The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.

Conditions

Generalized Anxiety Disorder (GAD)

Worrying

Anxiety

Study ID

NCT07391020

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Elevated worry as defined by a score of 60 or higher on the PSWQ.

Exclusion Criteria:

  • Score of 59 or lower on the PSWQ
  • If applicable, unstable psychiatric medication usage any time over the past 4 weeks
  • Failing attention checks in baseline data collection
  • Pregnancy

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Safety Behavior Fading

Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed worry behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a worry behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Participants will also be able to track their progress using daily progress charts that show how their daily total safety behavior use changes throughout treatment.

active comparator: Progressive Muscle Relaxation (PMR)

Individuals randomly assigned to the PMR condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to systematically tense and release different muscle groups in the body in order to build awareness of tension and relaxation.

Interventions

Safety Behavior Fading for Pathological Worry

Participants are asked to reduce or eliminate safety behaviors via text message reminders, daily checklist, and daily progress chart to monitor progress.

Progressive Muscle Relaxation (PMR)

Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.

Primary outcome measure

  • Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) [ Time Frame: Day 0, Day 28, Day 56 ]
  • Worry Behaviors Inventory (Mahoney et al., 2016) [ Time Frame: Day 0, Day 28, Day 56 ]
  • Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006) [ Time Frame: Day 0, Day 28, Day 56 ]
  • Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000). [ Time Frame: Day 0 ]
  • Theoretical Framework of Acceptability Questionnaire (TFA; Sekhon et al., 2022) [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Matthew Sala, B.S.

850-645-8729sala@psy.fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32304

Contacts

Matthew Sala, B.S.

850-645-8729sala@psy.fsu.edu

Principal Investigator:

Jesse Cougle, Ph.D.

More Information

Sponsor

Florida State University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • safety behaviors
  • worry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-04-30.