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NCT Number: NCT07391020

Text Message Safety Behavior Fading 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.

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Key information

Conditions

Generalized Anxiety Disorder (GAD) Anxiety Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Worrying

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32304, United States

Location status: Recruiting

Location contact

Jesse Cougle, Ph.D.

PRINCIPAL_INVESTIGATOR

Matthew Sala, B.S.

CONTACT

[email protected]

850-645-8729

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Progressive Muscle Relaxation (PMR)

Behavioral

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

Primary outcomes

  1. Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990)

    Time frame: Day 0, Day 28, Day 56

    Self-report scale that measures levels of worry. Scores range from 16 to 80 with higher scores indicating higher levels of worry.

  2. Worry Behaviors Inventory (Mahoney et al., 2016)

    Time frame: Day 0, Day 28, Day 56

    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.

  3. Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006)

    Time frame: Day 0, Day 28, Day 56

    Self-report scale that measures generalized anxiety symptom severity. Scores range from 0 to 21, with higher scores indicating higher levels of generalized anxiety.

  4. Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000).

    Time frame: Day 0

    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.

  5. Theoretical Framework of Acceptability Questionnaire (TFA; Sekhon et al., 2022)

    Time frame: Day 28

    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.

Secondary outcomes

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

    Time frame: Day 0, Day 28, Day 56

    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.

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

    Time frame: Day 0, Day 28, Day 56

    Self-report scale measuring levels of anxious somatic arousal. Scores range from 6 to 30, with higher scores indicating higher levels of anxious arousal.

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

    Time frame: Day 0, Day 28, Day 56

    Self-report scale that measures intolerance of uncertainty. Scores range from 12 to 60 with higher scores indicating higher levels of intolerance of uncertainty.

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

    Time frame: Day 0, Day 28, Day 56

    Self-report scale that measures anxiety sensitivity. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety sensitivity.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Sala, B.S.

CONTACT

[email protected]

850-645-8729

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Safety Behavior Fading Intervention for Pathological Worry

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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