Social AnxietyNCT03562650
Text Message Treatment for Social Anxiety
A study testing Safety Behavior Fading and Present Centered in people with Social Anxiety, run by Florida State University at 1 site in United States.
Trial summary
This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Safety Behavior Fading and Present Centered
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2018to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social Phobia Inventory score > 29
Who cannot join
- receiving therapy
- changes in the past 4 weeks with medication for emotional difficulties
- psychotic symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Department of Psychology
Tallahassee, Florida, 32306
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Safety Behavior Fading, Present Centered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Behavior FadingBehavioural
Participants are asked to fade their three most common safety behaviors associated with their social anxiety
Present CenteredBehavioural
Participants are asked to try to increase their focus on the present.
| Study group | Role | What they receive |
|---|---|---|
| Safety Behavior Fading | Experimental | 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. Receives: Behavioral: Safety Behavior Fading |
| Present Centered | Active comparator | Participants receive texts every other day for a month asking them to try to focus on the present that day. Receives: Behavioral: Present Centered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary outcomes (2)
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.
Measured: 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)
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.
Measured: Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start27 Jan 2018
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active treatment and active treatment control conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562650
- Sponsor's protocol ID
- 2017.22461
- Other IDs
- 2017
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32105093
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Treatment for Social Anxiety
- ClinicalTrials.gov ID
- NCT03562650
- Acronym / sponsor ID
- 2017.22461
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Jan 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Active treatment and active treatment control conditions.
| Arm | Type | Receives |
|---|---|---|
| Safety Behavior Fading | Experimental | Behavioral: Safety Behavior FadingParticipants 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. |
| Present Centered | Active comparator | Behavioral: Present CenteredParticipants receive texts every other day for a month asking them to try to focus on the present that day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Social Phobia Inventory score > 29
Key exclusion criteria (3 listed)
- receiving therapy
- changes in the past 4 weeks with medication for emotional difficulties
- psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Behavior FadingParticipants are asked to fade their three most common safety behaviors associated with their social anxiety | Behavioural | Safety Behavior Fading |
| Present CenteredParticipants are asked to try to increase their focus on the present. | Behavioural | Present Centered |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 32105093Cougle 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Behavior Fading and Present Centered in people with Social Anxiety, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.