Generalized Anxiety Disorder (GAD)NCT07391020
Text Message Safety Behavior Fading for Pathological Worry
A study testing Safety Behavior Fading for Pathological Worry and Progressive Muscle Relaxation (PMR) in people with Generalized Anxiety Disorder (GAD) and Worrying, run by Florida State University at 1 site in United States.
Trial summary
The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Worrying, Anxiety
- What is being tested?
- Safety Behavior Fading for Pathological Worry and Progressive Muscle Relaxation (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated worry as defined by a score of 60 or higher on the PSWQ.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: 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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder (GAD), Worrying, Anxiety
- Being tested
- Safety Behavior Fading for Pathological Worry, Progressive Muscle Relaxation (PMR)
- Keywords
- safety behaviors, worry
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Behavior Fading for Pathological WorryBehavioural
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)Behavioural
Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Progressive Muscle Relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two conditions
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
- Investigators
- Jesse Cougle, Ph.D., Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391020
- Sponsor's protocol ID
- STUDY00005991
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Behavior Fading Intervention for Pathological Worry
- ClinicalTrials.gov ID
- NCT07391020
- Acronym / sponsor ID
- STUDY00005991
- Conditions
- Generalized Anxiety Disorder (GAD), Worrying, Anxiety
- Keywords
- safety behaviors, worry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two conditions
| Arm | Type | Receives |
|---|---|---|
| Safety Behavior Fading | Experimental | Behavioral: Safety Behavior Fading for Pathological WorryIndividuals 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. |
| Progressive Muscle Relaxation (PMR) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated worry as defined by a score of 60 or higher on the PSWQ.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Behavior Fading for Pathological WorryParticipants are asked to reduce or eliminate safety behaviors via text message reminders, daily checklist, and daily progress chart to monitor progress. | Behavioural | Safety Behavior Fading |
| Progressive Muscle Relaxation (PMR)Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise. | Behavioural | Progressive Muscle Relaxation (PMR) |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Time frame: Day 0, Day 28, Day 56
NIH Toolbox Fear - Somatic Arousal Scale (Pilkonis et al., 2013)
Time frame: Day 0, Day 28, Day 56
Intolerance of Uncertainty Scale - 12 item version (IUS-12; Carleton et al., 2007)
Time frame: Day 0, Day 28, Day 56
Short Scale Anxiety-Sensitivity Index (SSASI; Zvolensky et al., 2018)
Time frame: Day 0, Day 28, Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Cougle, Ph.D. study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Behavior Fading for Pathological Worry and Progressive Muscle Relaxation (PMR) in people with Generalized Anxiety Disorder (GAD) and Worrying, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) (time frame: Day 0, Day 28, Day 56). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.