Text Message Safety Behavior Fading for Pathological Worry

Safety Behavior Fading Intervention for Pathological Worry

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Generalized Anxiety Disorder (GAD); Worrying
• Intervention / Treatment: Behavioral: Safety Behavior Fading for Pathological Worry; Behavioral: Progressive Muscle Relaxation (PMR)

Detailed Description

Safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of worry-related safety behaviors.

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. Text messaging will be managed by EZTexting - a service that manages mass texting protocols. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today's checklist: [link to checklist]." 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Sala, B.S.; Phone Number: 850-645-8729; Email: sala@psy.fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32304
      • Recruiting
      • Florida State University
      • Contact: Matthew Sala, B.S.; Phone Number: 850-645-8729; Email: sala@psy.fsu.edu
      • Principal Investigator: Jesse Cougle, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: Progressive Muscle Relaxation (PMR); Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990)	Self-report scale that measures levels of worry. Scores range from 16 to 80 with higher scores indicating higher levels of worry.	Day 0, Day 28, Day 56
Worry Behaviors Inventory (Mahoney et al., 2016)	Self-report scale that measures frequency of worry-related safety behavior use. Scores range from 0 to 44 with higher scores indicating more frequent worry-related safety behavior use.	Day 0, Day 28, Day 56
Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006)	Self-report scale that measures generalized anxiety symptom severity. Scores range from 0 to 21, with higher scores indicating higher levels of generalized anxiety.	Day 0, Day 28, Day 56
Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000).	Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Three items are rated on a 1-9 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility.	Day 0
Theoretical Framework of Acceptability Questionnaire (TFA; Sekhon et al., 2022)	Self-report scale for measuring treatment acceptability. Each item is rated on a 1-5 scale measuring agreement with each statement. For four items, higher scores reflect higher levels of acceptability. For the remaining four items, higher scores reflect lower levels of acceptability. Scores for each subscale range from 4-20.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)	Self-report measure of depression symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 30 with higher scores indicating greater depression severity.	Day 0, Day 28, Day 56
NIH Toolbox Fear - Somatic Arousal Scale (Pilkonis et al., 2013)	Self-report scale measuring levels of anxious somatic arousal. Scores range from 6 to 30, with higher scores indicating higher levels of anxious arousal.	Day 0, Day 28, Day 56
Intolerance of Uncertainty Scale - 12 item version (IUS-12; Carleton et al., 2007)	Self-report scale that measures intolerance of uncertainty. Scores range from 12 to 60 with higher scores indicating higher levels of intolerance of uncertainty.	Day 0, Day 28, Day 56
Short Scale Anxiety-Sensitivity Index (SSASI; Zvolensky et al., 2018)	Self-report scale that measures anxiety sensitivity. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety sensitivity.	Day 0, Day 28, Day 56

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Study Director: Jesse Cougle, Ph.D., Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: worry; safety behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis; Autogenic Training
• Other Study ID Numbers: STUDY00005991

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