Social AnxietyNCT04450303
Social Anxiety Telehealth Therapy Study
A study testing Telehealth CBT in people with Social Anxiety, run by Stanford University at 1 site in United States.
Trial summary
The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Telehealth CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 2 Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+,
- Liebowitz Social Anxiety Scale (LSAS) total score > 50
- Fluent spoken and written English
- Access to the internet via a smartphone or computer with a camera
- Ability to provide informed consent.
Who cannot join
- History of mania or psychosis
- Moderate or severe substance use disorder within the past year
- Current psychiatric diagnosis of greater impairment than that arising from social anxiety
- High risk for suicide (>8 on the Mini International Neuropsychiatric Interview suicidality section)
- Prior exposure therapy (more than 2 sessions)
- Current psychotropic medication use
- Current psychotherapy other than couples counseling.
Trial locations and contacts
1 site in 1 country.
About this study
The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.
- Conditions
- Social Anxiety
- Being tested
- Telehealth CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth CBTBehavioural
Also called CALM
The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Therapy | Experimental | Not described Receives: Behavioral: Telehealth CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS)
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
Measured: 12 weeks
Satisfaction with Therapy and Therapists Scale (STTS)
Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.
Measured: 12 weeks
UCLA Loneliness Scale version 3
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Measured: 12 weeks
Secondary outcomes (2)
Liebowitz Social Anxiety Scale (LSAS)
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
Measured: 24 weeks
UCLA Loneliness Scale version 3
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start30 Oct 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
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.
- More trials run by Stanford 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tali Manber Ball, PhD, Stanford University
- Investigators
- Tali Ball, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450303
- Sponsor's protocol ID
- 56697
- Status last verified
- Sep 2021
- First submitted
- 24 Jun 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Anxiety Telehealth Therapy Study
- ClinicalTrials.gov ID
- NCT04450303
- Acronym / sponsor ID
- 56697
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 29 Jun 2020 (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.
The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth Therapy | Experimental | Behavioral: Telehealth CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18+,
- Liebowitz Social Anxiety Scale (LSAS) total score > 50
- Fluent spoken and written English
- Access to the internet via a smartphone or computer with a camera
- Ability to provide informed consent.
Key exclusion criteria (7 listed)
- History of mania or psychosis
- Moderate or severe substance use disorder within the past year
- Current psychiatric diagnosis of greater impairment than that arising from social anxiety
- High risk for suicide (>8 on the Mini International Neuropsychiatric Interview suicidality section)
- Prior exposure therapy (more than 2 sessions)
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 |
|---|---|---|
| Telehealth CBTAlso: CALMThe Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium. | Behavioural | Telehealth Therapy |
Primary outcome
Liebowitz Social Anxiety Scale (LSAS)
Time frame: 12 weeks
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
Satisfaction with Therapy and Therapists Scale (STTS)
Time frame: 12 weeks
Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.
UCLA Loneliness Scale version 3
Time frame: 12 weeks
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
2 secondary outcomes
Liebowitz Social Anxiety Scale (LSAS)
Time frame: 24 weeks
UCLA Loneliness Scale version 3
Time frame: 24 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 23 Sep 2021.
- 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.
Tali Ball, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth CBT in people with Social Anxiety, run by Stanford 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 5 inclusion and 7 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 23 Sep 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?
Liebowitz Social Anxiety Scale (LSAS) (time frame: 12 weeks). 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 23 Sep 2021.