Social AnxietyNCT04196296
Treatment Seeking for Social Anxiety
A study testing Psychoeducation and Motivation in people with Social Anxiety, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This study developed and then compared via randomized trial two brief online interventions targeting increasing treatment-seeking behavior in social anxiety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Psychoeducation and Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 919 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2016to 6 Jul 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High social anxiety (score >30 on Social Phobia Inventory (SPIN) Connor et al., 2000)
- Fluent in English
- Amazon Mechanical Turk HIT approval rate > 95%
- Amazon Mechanical Turk account listed as US resident
Who cannot join
- Already enrolled in target treatments (i.e. CBT for social anxiety, using social anxiety self-help book, or participating in online treatment for social anxiety)
- Indicating that they would "never consider" treatment for social anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: Brief Online Interventions to Facilitate Treatment Seeking for Social Anxiety
This study developed and then compared via randomized trial two brief online interventions targeting increasing treatment-seeking behavior in social anxiety.
- Conditions
- Social Anxiety
- Being tested
- Psychoeducation, Motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Online psychoeducation about social anxiety, evidence-based treatments that target social anxiety, and treatment referral/resource information.
MotivationBehavioural
Online exercises/activities regarding social anxiety (and treatment thereof) based in principles from Acceptance and Commitment Therapy (ACT) and Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET).
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
| Psychoeducation plus Motivation Enhancement | Experimental | Not described Receives: Behavioral: Psychoeducation; Behavioral: Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment seeking motivations: Attitudes toward seeking treatment for social anxiety.
Affective attitudes toward seeking treatment for social anxiety were assessed using a standard 7-item 1-7 semantic differential scale in which participants rated "seeking treatment for social anxiety in the next month would be" according to opposite adjective pairs (e.g., "Unhealthy"/"Healthy"). Possible scores range from 7-49, with higher scores indicating more favorable attitudes toward seeking treatment for social anxiety.
Measured: Change from baseline to one-month follow-up
Treatment seeking motivations: Intentions to seek treatment for social anxiety.
As the existing literature lacks a sufficient and specific scale for assessing intentions to seek treatment, we developed a scale based on the Theory of Planned Behavior (https://doi.org/10.1016/0749-5978(91)90020-T) as well as crucial steps toward seeking treatment identified previously (https://doi.org/10.1016/S0887-6185(02)00259-1). The resulting scale includes 13 total items assessing intentions to seek treatment for social anxiety in the following month. Items were rated using Likert scales from 1 ("strongly disagree"/"not very likely") to 7 ("strongly agree"/"very likely"), with higher scores indicating greater intention to seek treatment for social anxiety within the following month.
Measured: Change from baseline to one-month follow-up
Treatment seeking motivations: Perceived behavioral control/confidence regarding seeking treatment for social anxiety.
Paralleling the intentions scale above, the present study developed a measure of perceived behavioral control regarding seeking treatment for social anxiety, as the existing literature lacked a sufficient and specific measure. The resulting scale includes 14 total items assessment perceived ability to seek treatment for social anxiety in the following month. Items were rated using Likert scales from 1 ("strongly disagree") to 7 ("strongly agree"), with higher scores indicating greater perceived ability to seek treatment for social anxiety.
Measured: Change from baseline to one-month follow-up
Secondary outcomes (1)
Treatment seeking behaviors
Checklist of behavioral steps toward seeking treatment within specific domains (i.e. in-person treatment, bibliotherapy, online-treatment, medication, and alternative treatments). Because the existing literature lacks a treatment-seeking behavior questionnaire, we developed a behavioral checklist adapted from Buckner and Schmidt (2009; doi: 10.1016/j.brat.2009.04.009). The measure included 19 total treatment-seeking behaviors across the above listed domains, and as such scores could range from 0 (no steps taken toward seeking treatment since intervention) to 19 (every listed step toward every type of treatment taken since the intervention). Higher scores are considered the better outcome in the present study.
Measured: One-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start28 Mar 2016
- Primary completion6 Jul 2016
- Study completion6 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Arch, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196296
- Sponsor's protocol ID
- 15-0452
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Interventions to Facilitate Treatment Seeking for Social Anxiety
- ClinicalTrials.gov ID
- NCT04196296
- Acronym / sponsor ID
- 15-0452
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 6 Jul 2016 (actual)
- Study completion
- 6 Jul 2016 (actual)
- First posted
- 12 Dec 2019 (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 study developed and then compared via randomized trial two brief online interventions targeting increasing treatment-seeking behavior in social anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
| Psychoeducation plus Motivation Enhancement | Experimental | Behavioral: Psychoeducation, Behavioral: Motivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High social anxiety (score >30 on Social Phobia Inventory (SPIN) Connor et al., 2000)
- Fluent in English
- Amazon Mechanical Turk HIT approval rate > 95%
- Amazon Mechanical Turk account listed as US resident
Key exclusion criteria (2 listed)
- Already enrolled in target treatments (i.e. CBT for social anxiety, using social anxiety self-help book, or participating in online treatment for social anxiety)
- Indicating that they would "never consider" treatment for social anxiety
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 |
|---|---|---|
| PsychoeducationOnline psychoeducation about social anxiety, evidence-based treatments that target social anxiety, and treatment referral/resource information. | Behavioural | Psychoeducation, Psychoeducation plus Motivation Enhancement |
| MotivationOnline exercises/activities regarding social anxiety (and treatment thereof) based in principles from Acceptance and Commitment Therapy (ACT) and Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET). | Behavioural | Psychoeducation plus Motivation Enhancement |
Primary outcome
Treatment seeking motivations: Attitudes toward seeking treatment for social anxiety.
Time frame: Change from baseline to one-month follow-up
Affective attitudes toward seeking treatment for social anxiety were assessed using a standard 7-item 1-7 semantic differential scale in which participants rated "seeking treatment for social anxiety in the next month would be" according to opposite adjective pairs (e.g., "Unhealthy"/"Healthy"). Possible scores range from 7-49, with higher scores indicating more favorable attitudes toward seeking treatment for social anxiety.
Treatment seeking motivations: Intentions to seek treatment for social anxiety.
Time frame: Change from baseline to one-month follow-up
As the existing literature lacks a sufficient and specific scale for assessing intentions to seek treatment, we developed a scale based on the Theory of Planned Behavior (https://doi.org/10.1016/0749-5978(91)90020-T) as well as crucial steps toward seeking treatment identified previously (https://doi.org/10.1016/S0887-6185(02)00259-1). The resulting scale includes 13 total items assessing intentions to seek treatment for social anxiety in the following month. Items were rated using Likert scales from 1 ("strongly disagree"/"not very likely") to 7 ("strongly agree"/"very likely"), with higher scores indicating greater intention to seek treatment for social anxiety within the following month.
Treatment seeking motivations: Perceived behavioral control/confidence regarding seeking treatment for social anxiety.
Time frame: Change from baseline to one-month follow-up
Paralleling the intentions scale above, the present study developed a measure of perceived behavioral control regarding seeking treatment for social anxiety, as the existing literature lacked a sufficient and specific measure. The resulting scale includes 14 total items assessment perceived ability to seek treatment for social anxiety in the following month. Items were rated using Likert scales from 1 ("strongly disagree") to 7 ("strongly agree"), with higher scores indicating greater perceived ability to seek treatment for social anxiety.
1 secondary outcome
Treatment seeking behaviors
Time frame: One-month follow-up
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 12 Dec 2019.
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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 Psychoeducation and Motivation in people with Social Anxiety, run by University of Colorado, Boulder 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 4 inclusion and 2 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 12 Dec 2019. 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?
Treatment seeking motivations: Attitudes toward seeking treatment for social anxiety. (time frame: Change from baseline to one-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2019.