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The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
- Elevated worry as defined by a score of 60 or higher on the PSWQ.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Sala, B.S. | Contact | 850-645-8729 | sala@psy.fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jesse Cougle, Ph.D. | Florida State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32304 | United States |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Participants are randomized to one of two conditions
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| Progressive Muscle Relaxation (PMR) | Behavioral | Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise. |
|
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 |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |