Text Message Safety Behavior Fading for Pathological Worry

Florida State University

Status: Not yet enrolling

Conditions: Worrying; Generalized Anxiety Disorder (GAD); Anxiety

Treatments: Behavioral: Progressive Muscle Relaxation (PMR); Behavioral: Safety Behavior Fading for Pathological Worry

Study type: Interventional

Funder types: Other

Identifiers

NCT07391020

STUDY00005991

Details and patient eligibility

About

The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Safety Behavior Fading

Experimental group

Description:

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.

Treatment:

Behavioral: Safety Behavior Fading for Pathological Worry

Progressive Muscle Relaxation (PMR)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Progressive Muscle Relaxation (PMR)