Social Anxiety DisorderNCT04622930
Waitlist-Control Trial of Smartphone (App-based) CBT for Social Anxiety Disorder (SAD), Withdrawn
A study testing Smartphone-delivered CBT for SAD in people with Social Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Smartphone-delivered CBT for SAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Dec 2025
- 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
- At least 18 years of age
- Current diagnosis of primary DSM-5 SAD, based on MINI
- Currently living in the United States
Who cannot join
- Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- Past participation in ≥ 4 sessions of CBT for SAD
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 *EDIT*
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
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- Concurrent psychological treatment
- Does not own a supported mobile Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).
Read the detailed description
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with SAD recruited nationally. Eligible subjects (N=80) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for SAD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for SAD will be feasible and acceptable to individuals with SAD, and that it will lead to greater reductions in SAD symptom severity compared to the passage of time (waitlist control).
- Conditions
- Social Anxiety Disorder
- Being tested
- Smartphone-delivered CBT for SAD
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-delivered CBT for SADDevice
12-week Smartphone-delivered CBT for SAD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for SAD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Smartphone-delivered CBT for SAD | Experimental | 12-week Smartphone delivered CBT for SAD. Receives: Device: Smartphone-delivered CBT for SAD |
| 12 Week Waitlist Control | Other | 12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control). Receives: Device: Smartphone-delivered CBT for SAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
Measured: Endpoint (week 12)
Secondary outcomes (3)
Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12. The CESD-R is a self-report measure of depressive symptoms consisting of 20 scale items with responses ranging from 0 to 4, including two questions about suicidal ideation (item #14, #15). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Measured: Endpoint (week 12)
Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12. The WSAS uses a Likert scale from 0 (not at all impaired) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.
Measured: Endpoint (week 12)
Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12. The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Measured: Endpoint (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: No longer proceeding with this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Koa Health B.V.
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622930
- Sponsor's protocol ID
- 2018P001671
- Status last verified
- Jun 2026
- First submitted
- 13 Oct 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
- ClinicalTrials.gov ID
- NCT04622930
- Acronym / sponsor ID
- 2018P001671
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer proceeding with this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Koa Health B.V.
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Nov 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 investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).
Detailed description
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with SAD recruited nationally. Eligible subjects (N=80) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for SAD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for SAD will be feasible and acceptable to individuals with SAD, and that it will lead to greater reductions in SAD symptom severity compared to the passage of time (waitlist control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Smartphone-delivered CBT for SAD | Experimental | Device: Smartphone-delivered CBT for SAD12-week Smartphone delivered CBT for SAD. |
| 12 Week Waitlist Control | Other | Device: Smartphone-delivered CBT for SAD12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Current diagnosis of primary DSM-5 SAD, based on MINI
- Currently living in the United States
Key exclusion criteria (9 listed)
- Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- Past participation in ≥ 4 sessions of CBT for SAD
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 *EDIT*
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 |
|---|---|---|
| Smartphone-delivered CBT for SAD12-week Smartphone-delivered CBT for SAD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for SAD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills. | Device | 12 Week Waitlist Control, Experimental: Smartphone-delivered CBT for SAD |
Primary outcome
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
Time frame: Endpoint (week 12)
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
3 secondary outcomes
Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.
Time frame: Endpoint (week 12)
Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.
Time frame: Endpoint (week 12)
Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.
Time frame: Endpoint (week 12)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Sabine Wilhelm, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-delivered CBT for SAD in people with Social Anxiety Disorder, run by Massachusetts General Hospital 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 Jul 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in SAD severity (LSAS) at the end of treatment/waitlist period. (time frame: Endpoint (week 12)). 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 1 Jul 2026.