Text Message Safety Behavior Fading for Pathological Worry
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFlorida State University
About this trial
The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Safety Behavior Fading for Pathological Worry
BehavioralParticipants 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)
BehavioralParticipants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Safety Behavior FadingExperimental treatment 1 intervention
Group B: Progressive Muscle Relaxation (PMR)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 0, Day 28, Day 562
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.
Time frame
Day 0, Day 28, Day 563
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.
Time frame
Day 0, Day 28, Day 564
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.
Time frame
Day 0Secondary outcomes
1
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.
Time frame
Day 0, Day 28, Day 562
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.
Time frame
Day 0, Day 28, Day 563
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.
Time frame
Day 0, Day 28, Day 564
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.
Time frame
Day 0, Day 28, Day 56Sponsors and contacts
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Source ClinicalTrials.gov