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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03562650
Other study ID # 2017.22461
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 27, 2018
Est. completion date March 27, 2019

Study information

Verified date January 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder.


Description:

This study hopes to assess whether a month long text message based safety behavior fading protocol is effective in reducing safety behaviors and social anxiety symptoms. Over the course of four consecutive weeks, text messages will be sent to participants the first day of the study and every other day for four weeks (14 texts in total). These text messages will remind participants to either avoid using their three most engaged in safety behaviors (assessed at pre-treatment) or to stay present-focused. The past week frequency of the participants' safety behaviors will be assessed at the beginning of pre-treatment, post-treatment, and four week follow up assessments Participants will be asked to complete an additional online questionnaire for both a post-treatment and a 4-week post-treatment follow up assessment. We hypothesize that: 1) the safety behavior group will show a greater overall reduction in social anxiety symptoms, 2) that the safety behavior group will show a reduction in the frequency of safety behavior use, and 3) that the present-focused group will show an increase in mindfulness.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date March 27, 2019
Est. primary completion date March 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Social Phobia Inventory score > 29 Exclusion Criteria: - receiving therapy - changes in the past 4 weeks with medication for emotional difficulties - psychotic symptoms

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Safety Behavior Fading
Participants are asked to fade their three most common safety behaviors associated with their social anxiety
Present Centered
Participants are asked to try to increase their focus on the present.

Locations

Country Name City State
United States Florida State University, Department of Psychology Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Social Phobia Inventory (SPIN) Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms. Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary Subtle Avoidance Frequency Examination(SAFE) Self report scale used to assess how often people use safety behaviors to cope with their anxiety. Scores range from 33 to 165. Higher total scores are associated with more frequent safety behavior use. Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) Self-report used to measure mindfulness, including awareness of thoughts and feelings. Total scores range from 12 to 48 with higher scores indicating a greater ability to be mindful, present in the moment, and aware of thoughts and feelings. Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
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