Text Message Safety Behavior Fading for Pathological Worry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Safety Behavior Fading for Pathological Worry, Progressive Muscle Relaxation (PMR).
- Who it may be relevant to
- Registry conditions: Generalized Anxiety Disorder (GAD), Worrying, Anxiety. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety Behavior Fading Intervention for Pathological Worry
Overview
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.
Interventions
- 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. - Behavioral Progressive Muscle Relaxation (PMR)
Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.
Primary outcome measures
- Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) [Time frame: Day 0, Day 28, Day 56]
- Worry Behaviors Inventory (Mahoney et al., 2016) [Time frame: Day 0, Day 28, Day 56]
- Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006) [Time frame: Day 0, Day 28, Day 56]
- Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000). [Time frame: Day 0]
- Theoretical Framework of Acceptability Questionnaire (TFA; Sekhon et al., 2022) [Time frame: Day 28]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Florida State University — Tallahassee
Identifiers
NCT: NCT07391020 · STUDY00005991