Text Message Treatment for Social Anxiety

• ClinicalTrials.gov Identifier: NCT03562650
• Recruitment Status: Completed
• First Posted: June 19, 2018
• Last Update Posted: January 29, 2021
• Sponsor: Florida State University
• Information provided by (Responsible Party): Jesse Cougle, Florida State University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Social Anxiety	Behavioral: Safety Behavior Fading; Behavioral: Present Centered	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Active treatment and active treatment control conditions.
• Masking: Single (Participant)
• Masking Description: All participants are assigned to a condition and given a treatment justification, but are not told whether they are in the treatment or control condition.
• Primary Purpose: Treatment
• Official Title: Computerized Treatment for Social Anxiety
• Actual Study Start Date: January 27, 2018
• Actual Primary Completion Date: March 27, 2019
• Actual Study Completion Date: March 27, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Safety Behavior Fading; Participants are asked to pick their three most common safety behaviors from a list and then receive texts every other day for a month reminding them to fade those behaviors.	Behavioral: Safety Behavior Fading; Participants are asked to fade their three most common safety behaviors associated with their social anxiety
Active Comparator: Present Centered; Participants receive texts every other day for a month asking them to try to focus on the present that day.	Behavioral: Present Centered; Participants are asked to try to increase their focus on the present.

Outcome Measures

Primary Outcome Measures :

1. Social Phobia Inventory (SPIN) [ Time Frame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks) ]
   Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.

Secondary Outcome Measures :

1. Subtle Avoidance Frequency Examination(SAFE) [ Time Frame: Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks) ]
   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.
2. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [ Time Frame: Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Social Phobia Inventory score > 29

Exclusion Criteria:

• receiving therapy
• changes in the past 4 weeks with medication for emotional difficulties
• psychotic symptoms

Contacts and Locations

Locations

United States, Florida

Florida State University, Department of Psychology

Tallahassee, Florida, United States, 32306

Sponsors and Collaborators

Florida State University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cougle JR, Mueller NE, McDermott KA, Wilver NL, Carlton CN, Okey SA. Text message safety behavior reduction for social anxiety: A randomized controlled trial. J Consult Clin Psychol. 2020 May;88(5):445-454. doi: 10.1037/ccp0000494. Epub 2020 Feb 27.

• Responsible Party: Jesse Cougle, Associate Professor, Florida State University
• ClinicalTrials.gov Identifier: NCT03562650
• Other Study ID Numbers: 2017.22461
• First Posted: June 19, 2018
• Last Update Posted: January 29, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders