Waitlist-Control Trial of Smartphone (App-based) CBT for Social Anxiety Disorder (SAD)

NCT04622930 | Withdrawn DMC FDA Device

• 1 other identifier: 2018P001671
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 (week 12).

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  Endpoint (week 12)

Study Arms (2)

Experimental: Smartphone-delivered CBT for SAD

EXPERIMENTAL

12-week Smartphone delivered CBT for SAD.

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).

Device: Smartphone-delivered CBT for SAD

Interventions

Smartphone-delivered CBT for SAD DEVICE

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.

12 Week Waitlist Control; Experimental: Smartphone-delivered CBT for SAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Current diagnosis of primary DSM-5 SAD, based on MINI
• Currently living in the United States

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Koa Health B.V.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Sagittal Abdominal Diameter

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Phycology

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 10, 2020
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)