Text Message Treatment for Social Anxiety
Primary Purpose
Social Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Behavior Fading
Present Centered
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety
Eligibility 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
Sites / Locations
- Florida State University, Department of Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Safety Behavior Fading
Present Centered
Arm Description
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.
Participants receive texts every other day for a month asking them to try to focus on the present that day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03562650
First Posted
February 5, 2018
Last Updated
January 26, 2021
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT03562650
Brief Title
Text Message Treatment for Social Anxiety
Official Title
Computerized Treatment for Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2018 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active treatment and active treatment control conditions.
Masking
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.
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Safety Behavior Fading
Arm Type
Experimental
Arm Description
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.
Arm Title
Present Centered
Arm Type
Active Comparator
Arm Description
Participants receive texts every other day for a month asking them to try to focus on the present that day.
Intervention Type
Behavioral
Intervention Name(s)
Safety Behavior Fading
Intervention Description
Participants are asked to fade their three most common safety behaviors associated with their social anxiety
Intervention Type
Behavioral
Intervention Name(s)
Present Centered
Intervention Description
Participants are asked to try to increase their focus on the present.
Primary Outcome Measure Information:
Title
Social Phobia Inventory (SPIN)
Description
Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Time Frame
Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary Outcome Measure Information:
Title
Subtle Avoidance Frequency Examination(SAFE)
Description
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.
Time Frame
Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Title
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Description
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.
Time Frame
Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Florida State University, Department of Psychology
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32105093
Citation
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.
Results Reference
derived
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Text Message Treatment for Social Anxiety
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