- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562650
Text Message Treatment for Social Anxiety
January 26, 2021 updated by: Jesse Cougle, Florida State University
Computerized Treatment for Social Anxiety
This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Tallahassee, Florida, United States, 32306
- Florida State University, Department of Psychology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Participants are asked to try to increase their focus on the present.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
|
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.
|
Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2018
Primary Completion (Actual)
March 27, 2019
Study Completion (Actual)
March 27, 2019
Study Registration Dates
First Submitted
February 5, 2018
First Submitted That Met QC Criteria
June 18, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017.22461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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