Text Message Safety Behavior Fading for Pathological Worry

NCT07391020 | Recruiting

• 1 other identifier: STUDY00005991
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

safety behaviors; worry

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)

  Day 0, Day 28, Day 56

• NIH Toolbox Fear - Somatic Arousal Scale (Pilkonis et al., 2013)

  Day 0, Day 28, Day 56

• Intolerance of Uncertainty Scale - 12 item version (IUS-12; Carleton et al., 2007)

  Day 0, Day 28, Day 56

• Short Scale Anxiety-Sensitivity Index (SSASI; Zvolensky et al., 2018)

  Day 0, Day 28, Day 56

Study Arms (2)

Safety Behavior Fading

EXPERIMENTAL

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

Progressive Muscle Relaxation (PMR)

ACTIVE COMPARATOR

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)

Interventions

Safety Behavior Fading for Pathological Worry BEHAVIORAL

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

Safety Behavior Fading

Progressive Muscle Relaxation (PMR) BEHAVIORAL

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

Progressive Muscle Relaxation (PMR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jesse Cougle, Ph.D.

  Florida State University

  STUDY DIRECTOR

Central Study Contacts

Matthew Sala, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized to one of two conditions

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)